2018 europeanpharmaceuticalreview.com Providing high-quality content for the European pharmaceutical sector since 1996 MEDIA PLANNER 2018/19 Charles River has been working with EPR for a little bit less than 10 years now and we highly estimate the quality of service your company provides. We sincerely appreciate your responsiveness, the evolutions of your services portfolio and the way you conduct scientific communication. We look forward to doing business with you for years to come and leverage the European scientific leadership. MÉLANCOLIE SPEDITO-JOVIAL Business & Marketing Manager, Microbial Solutions Charles River RELEASED: JULY 2018
Transcript
2018europeanpharmaceuticalreview.com
Providing high-quality content for the European pharmaceutical sector since 1996
MEDIA PLANNER2018/19
Charles River has been working with EPR for a little bit less than 10 years now and we highly estimate
the quality of service your company provides. We sincerely appreciate your responsiveness, the evolutions of your services portfolio and the way you conduct scientifi c communication. We look forward to doing business with you for years to come and leverage the European scientifi c leadership.
MÉLANCOLIE SPEDITO-JOVIALBusiness & Marketing Manager, Microbial SolutionsCharles River
RELEASED: JULY 2018
STEVEN BAERTSCHIPresidentBaertschi Consulting
PAUL ROYALLSenior LecturerKing’s College London
DAVIDP ELDERDirectorDavid P Elder Consultancy
JOSÉ MANUEL AMIGOAssociate ProfessorUniversity of Copenhagen
MICHAEL J MILLERPresidentMicrobiology Consultants
MICHAELH ELLIOTTChief ExecutiveAtrium Research & Consulting
SHERAZGULHead of Drug DiscoveryFraunhofer Institute for Molecular Biology and Applied Ecology
MATTHEW MORANDirectorBioPharmaChem Ireland
DONCLARKSenior Principal ScientistPfizer
Advisory Board
Note from the EditorThe pharmaceutical industry is facing a unique set of challenges, and an exciting range of opportunities in 2018/19 as global markets and patient requirements evolve while life sciences make huge strides forward. In some respects, pharma has never had it so good, according to consultants PwC, who predict that the global market could be worth nearly $1.6tn by 2020. The tools to develop remarkable new medicines are materialising, demand for products is escalating, and trade is getting easier. The fl ipside is that costs per molecule are still rising relentlessly and the number of new medicines reaching the market remains broadly fl at.
As the industry shifts its R&D focus from small molecules to biologics, adjusts to the potential of orphan drugs, and identifi es the opportunities and threats arising from biosimilars, its shape and focus is constantly changing. New technologies such as synthetic biology, artifi cial intelligence and big data require manufacturers to rapidly adapt and think ahead to reap the benefi ts for patients.
European Pharmaceutical Review keeps you abreast of industry developments, whether they relate to R&D, formulation and development, or business issues. Whatever your role in the industry, we have content that’s relevant and current for you. Most of our content is focused around our nine core topics: analytical techniques; biopharma; drug delivery; formulation; manufacturing; packaging; QA/QC; R&D; regulation and legislation. But we will cover anything of interest and relevance to those that work in the pharmaceutical industry.
Whether you prefer to receive our news, features and educational articles via print, online, digital newsletters, social media or webinars, rest assured that EPR is well connected to, and fully informed about, the issues and the people at the heart of your industry.
A global network of highly respected leaders in their specialist fi elds who continuously compile and advise our teams on curating the highest quality content for our international audience.
JO PISANIPharmaceutical and Life Science Consulting LeaderPwC
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Analytical Support for R&D, Clinical Development andLicensed Manufacture
Leaders in pharmaceutical analysisButterworth Laboratories Ltd are a UK-based contract laboratory providing analytical chemistry services to the global pharmaceutical industry in support of R&D, clinical development and licensed manufacture. We are GLP, GCP and GMP-compliant, FDA and MHRA-inspected.
WE HAVE extensive experience in the analysis of raw materials, finished products, devices and packaging in accordance with internationally published (EP, BP, USP, JP, JPE), client-supplied, or in-house developed, methods.
A wide range of state-of-the-art analytical instrumentation complements our classical competencies, enabling us to provide the most up-to-date and cost-effective analytical services.
What are the main areas that you can test for?We predominantly focus our analysis on confirming the identity and demonstrating the purity, safety and quality of materials, using techniques such as HPLC, GC, IC and ICP all to cGMP standards. Classical wet chemistry, elemental impurity and residual solvents analysis are particular specialisms of ours.
What are the main challenges that the pharmaceutical sector faces in testing for QA/QC?In terms of quality control, the age-old challenge is whether to retain in-house analytical capabilities as a manufacturer, or to outsource to a dedicated contract analytical supplier such as ourselves. This decision should really be driven by the assessment of core and non-core activities. Many companies choose to outsource raw material analysis and keep drug product testing in-house. The former is often
complex and sporadic, while the latter can be consistent and time constrained.
A major QA challenge currently is the data integrity requirements surrounding cGMP analysis. These have, and will continue to, push costs up across the industry due to the investment required in compliant analytical data systems and personnel.
What additional services do you provide?Being analytical chemists, we can apply our equipment and expertise to many applications across the wider industry. We offer development and validation of methods for ongoing use in quality control analysis.
What additional benefits are there to working with you?Our business is independent, so there are no shareholder dividends. This means we can re-invest our profits in two key ways: staff retention and capital investment in new equipment and laboratory facilities.
Retaining talent and expertise is critical to offering a first-class contract analytical service. It ensures that we can advise customers on the correct analytical approach and also quickly solve problems when they are encountered.
Investing in new and updated instrumentation ensures that we are offering the most up-to-date analytical methods to our customers.
The trend in the pharmaceutical industry is to globalise testing services. How can your company address the local needs of users?We have an established reputation forged over nearly 43 years of operation. This provides our local customers with absolute confidence in the quality of service they will receive, allowing them to focus on their core business, safe in the knowledge that their analysis is in experienced hands.
However, globalisation has reduced barriers, and approximately 30% of our business is outside of the UK, with many businesses choosing us over local suppliers. This demonstrates that we are able to offer as good a quality service to customers outside of the UK, as within it.
THE G U ID E TO. . . | TESTING SER VICES
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Spectroscopy Raman NIRBiopharma
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Mass Spec Microbiology ChromatographyBiopharma
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IngredientsBiopharma
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Chromatography Raman
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Virtually all characterisation techniques used to monitor the state of cells during bioproduction require direct physical contact, leading to measurement errors and handling problems. Bahman Farzi and Çetin Çetinkaya, from Clarkson University, explain how they have used non-contact ultrasonic excitation and high-frequency interferometric motion acquisition to characterise the surface adhesion and mechanical properties of single cells.
In addition to the online monitoring of cell culture pH, temperature and dissolved oxygen, biopharmaceutical manufacturers also need near real-time full structural insights into the drug substance. Rowan Moore, Simon Cubbon and Michael Blank, from Thermo Fisher Scientifi c, and NIBRT’s Jonathan Bones, consider whether high resolution mass spectrometry is the missing piece in continuous bioproduction.
Advanced therapy medicinal products (ATMPs) require diff erent procedures for clinical trials compared to traditional medicines. Parexel’s Andrea Zobel and Bridget Heelan discuss the regulatory, clinical and logistics challenges of ATMPs in clinical research.
BIOPHARMACEUTICAL DEVELOPMENT & PROCESSING
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europeanpharmaceuticalreview.com12
Ralph O. Schoenleber on peptidesEuropean Pharmaceutical Review Editor, Steve Bremer, discusses peptide research and the manufacture and development of glycosylated peptides with Ralph O. Schoenleber, PhD, VP Research and Development at Bachem AG.
Which current area of research at Bachem do you think is the most exciting, or likely to have the biggest impact on pharmaceutical research and development?Internal research projects at Bachem are primarily targeted to result in long-term commercial benefi t. The continuous investment in development and implementation of new chemistries and technologies is regarded as crucial for future success. This is especially the case since stringent and costly requirements from authorities and the demand for more complex structures from clients require major efforts to remain competitive.
In particular, the increasing interest in longer and signifi cantly more complex peptides and peptide conjugates represents a challenge for all peptide manufacturers. Unlike biotechnological production, the synthetic access to these macromolecules allows for substantial fi ne-tuning of these structures. Therefore, products with tailored properties can be developed, offering opportunities to achieve patent protection for the optimised structures.
What advantages does your chemical glycosylation of peptides give to drug developers?Glycosylation of peptide drugs can be a powerful way to enable optimisation of lead candidates. Chemical glycosylation permits the synthesis of peptides and proteins with pre-attached sugars. It has been shown to markedly improve drug properties such as half-life, binding affi nity and selectivity. Furthermore, compared to recombinant products, the chemically synthesised proteins
are more homogeneous. Selective, site-specifi c glycosylation leads to a homogeneous product with potential for more defi ned bioactivity compared to heterogeneous products.
What technological challenges are presented by the synthesis of longer and more complex peptides, and how are you overcoming these?Enhanced interest in long peptides, and even synthetic proteins, is a logical consequence of the development in biology and chemistry. In particular, progress in mass spectrometric techniques has facilitated the discovery of more complex peptides. As considerable progress in synthesis and ligation technologies has been realised, these molecules are well within the scope of current synthetic methodologies. Bachem’s research projects originate from the idea to continuously evaluate new chemistries and technologies to improve on existing processes in a dynamic fashion. Collaborations with external research partners like Prof S Kent complement these activities.
Can you summarise the key aspects of your ground-breaking and award-winning work on Interferon b-1a, and how this has been taken forward by other researchers?The partnership between Bachem and GlyTech is focused on the chemical development and manufacturing of glycosylated peptides. Bachem has the proven expertise to scale up and manufacture peptides at all volumes required, while GlyTech is capable of producing glycans in kilogram amounts by a proprietary technology. Bachem and GlyTech were the 2013 CPhI innovation prize fi nalist for their work on Interferon b-1a.
The selective chemical glycosylation has potential to be applied to a variety of peptides, owing to the concept of
Ralph O. Schoenleber, Bachem AG
www.bachem.com
improving current and future drugs via chemical glycosylation. For a lead peptide, which has been chosen for glycosylation, a library of over 50 specifi c human-type glycans is available. This technology has been used in several other projects, such as to manufacture glycosylated somatostatin analogues and glycosylated GLP-1. In all cases, drug improvements were achieved. Some of the glycopeptides emanating from the partnership are now in clinical trials.
What might the future hold for peptide research?For a contract manufacturing organisation in the competitive environment of pharma and biotechnology, research and development is extremely important to enhance customer satisfaction and service quality. Increasing demands on performance, combined with growing sustainability requirements, such as those relating to occupational safety as well as waste management, are chief concerns of our markets. There is a trend towards the development of molecules with higher complexity and, at the same time, the patent landscape is more and more crowded. Plus, requirements from customers and authorities with regard to documentation – and data integrity in particular – are changing the way people work.
In order to meet the increasing demands of the markets, a company needs the right combination of creative, innovative – but at the same time structured and accurately working – scientists on board, and they need to focus on the management of knowledge as a key factor to success. Efforts on knowledge management at Bachem focus on organisational objectives, such as continuous improvement, competitive advantage, innovation, and the sharing of ‘lessons learned’.
U N D ER THE MI CROSCOPE | BAC HEM AG
CHEMICAL GLYCOSYLATIONOF PEPTIDESBACHEM
Bachem and GlyTech, Inc.Two pioneers in their respective fieldscollaborating to advance innovation in drug development.
ADVANTAGES OF CHEMICAL GLYCOSYLATION
• Homogeneous products: chemical synthesis yieldswell-definedglycopeptides
• Most chemically synthesized peptide drugs can be easily adapted to glycosylation
• Competitive production costs
Improving the Pharmacokinetic Profile of Drugs
OH OH
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H3C
H3C
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OHOH
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www.bachem.com
MORE THAN 50 GLYCANS ARE AVAILABLE
europeanpharmaceuticalreview.com19
PerkinElmer LAMBDA 365 UV/Vis Spectrophotometer
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In particular, the LAMBDA 365 delivers state-of-the-art UV/Vis performance that meets the needs of pharmaceuticals, analytic chemists, geneticists, and manufacturing QA/QC analysts everywhere. With 21 CFR part 11 software available, the LAMBDA system is ready to support everything from standard methods and applications to those requiring regulatory compliance.
The system delivers a variable spectral bandwidth capability from 0.5nm to 20nm, to meet your application needs. And it can accommodate a wide range of accessories, including multicell changers (both water and Peltier temperature-controlled), solid sample accessories for transmission and reflectance, optical fibre probes for remote measurements, an integrating sphere for colour and diffuse measurements, and a range of cuvette holders to meet your sampling requirements.
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Software that works the way you workUVWinLab software mimics the way you work, guiding you through method development, analysis, reporting and results in a series of simple steps. With advanced software capabilities such as macros and sample tables, it’s easy to personalise all the stages of your analysis. With a single click, UVWinLab archives all your results and methods into a secure database, transforming your data from a collection of individual results into valuable knowledge to help you make faster decisions.
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europeanpharmaceuticalreview.com1 2@PharmaReview
PRESENTATION | YOUR CO M PAN Y N AM E EUROPEAN PHARMACEUTICAL REVIEW | Volume 23, Issue 03
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Anion Exchange ChromatographyFinal virus purification was accomplished using Nuvia Q Resin (Figure 4). This portion of the process achieved an additional twofold reduction of product volume along with a significant improvement in product purity (Figure 1C, lanes 4 –7 ). Following this operation, nonvirus proteins were no longer evident by SDS-PAGE (Figure 1C, lane 7).
Mixed-Mode ChromatographyInitial capture was accomplished using Nuvia cPrime Mixed-Mode Resin (Figure 3). This portion of the process achieved a tenfold reduction in processing volume and a significant reduction in feedstream contaminants (Figure 1C, lanes 2–4).
Final Process
Fig. 3. Representative mixed-mode chromatogram. OD 260 (—); OD 280 (—); conductivity (—).
0 60 120 180 240Time, min
2
0
100
0
mS
/cm
AU
Start of load 25 mM histidine, pH 6.0 (wash)
Flowthrough
240 250 260 270 280 290Time, min
1.2
0
60
0
mS
/cm
AU
100 mM NaOH (strip)
Product collection
75 mM Tris, 525 mM NaCl, pH 8.5 (elution)
Fig. 4. Representative anion exchange chromatogram. OD 260 (—); OD 280 (—); conductivity (—).
0 10 20 30 40 50Time, min
0.8
0
80
0
mS
/cm
AU Start of load
75 mM Tris, 250 mM NaCl, pH 8.0 (equilibration and wash)
75 mM Tris, 440 mM NaCl, pH 8.0 (pre-elution) 75 mM Tris,
1,000 mM NaCl, pH 7.5 (product elution)
100 mM acetate, 1,000 mM NaCl, pH 4.0 (strip)
Flowthrough Pre-elutionProduct collection
Conclusion
The final process yields an active, concentrated virus product with purity, HCP, and DNA levels comparable to clinical grade products. While the purification methods presented here were developed using the Ad5-E1+GFP model virus, they are expected to be applicable to recombinant adenoviruses in general, and to constructs derived from serotype 5 viruses, in particular. This efficient two-step purification process, Nuvia cPrime Mixed-Mode Resin followed by Nuvia Q Anion Exchange Resin, provided approximately 54% overall recovery of virus particles ( Table 1). This process is readily scalable and uses procedures and reagents compatible with cGMPs.
SDS-PAGE shows the progressive reduction of contaminating proteins at each step of our purification process (Figure 1). The five most prominent viral proteins — hexon, penton, core (V), hexon (VI), and core (VII) — are readily visible in the final purified product (Figure 1, lane 7).
Overall recovery of virus particles is approximately 54%, with DNA levels below detection and HCPs at 2 ng/1010 particles. These values are within current guidelines for clinical and possibly commercial use.
Abstract
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. These challenges mostly arise from the size and complexity of the virus. Here we present purification results of a cGMP-ready process developed for a recombinant adenovirus. The two-step column process results in an adenovirus preparation with high yield and very low host cell protein (HCP) and DNA contamination, comparable to clinical grade products. This process is readily scalable, simple, rapid, and efficient and is thus well-suited for the production of clinical grade viral vectors.
Fig. 1. Purification process results. Chromatograms from A, the mass capture and; B, the anion exchange steps; C, SDS-PAGE of intermediates and the final product. Lane 1, MW marker; lane 2, Nuvia cPrime load; lane 3, Nuvia cPrime flowthrough; lane 4, Nuvia cPrime elution/Nuvia Q load; lane 5, Nuvia Q flowthrough; lane 6, Nuvia Q pre-elution; lane 7, Nuvia Q product. OD 260 (—); OD 280 (—); conductivity (—).
Development of a cGMP-Ready Purification Process for Adenovirus Purification
A. Nuvia™ cPrime™ Resin
AU
B. Nuvia™ Q Resin
0 10 20 30 40 50Time, min
1.0
0.8
0.6
0.4
0.2
0
120
100
80
60
40
20
0
AU
mS
/cm
Flowthrough Pre-eluate Eluate
Strip
mS
/cm
0 40 80 120 160 200 240 280 320Time, min
2.6
2.2
1.8
1.4
1.0
0.6
0.2
120
100
80
60
40
20
0
Flowthrough
Eluate
Strip
C. Purity analysis of intermediates and final product
1 3 4 5 6 7
250
150100
75
5037
25201510
Hexon
PentonCore (V)
Hexon (VI)Core (VII)
2
Table 1. Viral particle recovery and impurity clearance.
SampleTotal virus
(x1011 particles)
Impurity levels (ng/1010 particles)
DNA HCP
Bulk harvest 30.6 3,144 n/d
Nuclease-treated harvest 31.8 30 3,022
Nuvia cPrime eluate 18.4 n/d 58
Nuvia Q eluate 16.4 <0.02 2
n/d, not determined.
Fig. 2. Behavior of the crude harvest on the Nuvia Q Column. OD 260 (—); OD 280 (—); conductivity (—). Blue shading indicates detection of significant transgene expression.
Introduction
Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. They offer several advantages including the capacity to accommodate up to 37 kb of foreign genetic material, very high infection efficiencies, the ability to infect a wide variety of both dividing and nondividing cell types, lack of integration into the host chromosome, and production systems capable of generating high virus titers. A two-column cGMP-ready purification process was developed for a recombinant adenovirus. We show that the final process yields an active, concentrated virus product with purity comparable to clinical grade products.
Process Development
Mass CaptureProcess developers seek high recovery and purity during initial capture. Affinity capture is usually not an option for the downstream processing of recombinant proteins, viruses, and second generation mAb-like proteins. The mixed-mode resin, Nuvia™ cPrime™, was chosen for initial capture because of its ability to quantitatively bind the virus, provide high recovery of active material, and clear DNA. Using a mixed-mode resin for capture enhances selectivity and delivers increased total protein recovery and purity. A nuclease digestion was introduced prior to column loading.
Anion Exchange ChromatographyThe anion exchange resin, Nuvia Q, was selected because it could adsorb virus at the higher sodium chloride concentration used during Nuvia cPrime elution (Figure 2). It was therefore easier to work with downstream of the Nuvia cPrime capture step, where the eluate had a sodium chloride concentration of approximately 500 mM going on to the anion exchange column.
0 10 20 30 40 50 60
Time, min
0.8
0.6
0.4
0.2
0
100
80
60
40
20
0
mA
U
mS
/cm
Nuvia Q
Anion Exchange ChromatographyFinal virus purification was accomplished using Nuvia Q Resin (Figure 4). This portion of the process achieved an additional twofold reduction of product volume along with a significant improvement in product purity (Figure 1C, lanes 4 –7 ). Following this operation, nonvirus proteins were no longer evident by SDS-PAGE (Figure 1C, lane 7).
Mixed-Mode ChromatographyInitial capture was accomplished using Nuvia cPrime Mixed-Mode Resin (Figure 3). This portion of the process achieved a tenfold reduction in processing volume and a significant reduction in feedstream contaminants (Figure 1C, lanes 2–4).
Final Process
Fig. 3. Representative mixed-mode chromatogram. OD 260 (—); OD 280 (—); conductivity (—).
0 60 120 180 240Time, min
2
0
100
0
mS
/cm
AU
Start of load 25 mM histidine, pH 6.0 (wash)
Flowthrough
240 250 260 270 280 290Time, min
1.2
0
60
0
mS
/cm
AU
100 mM NaOH (strip)
Product collection
75 mM Tris, 525 mM NaCl, pH 8.5 (elution)
Fig. 4. Representative anion exchange chromatogram. OD 260 (—); OD 280 (—); conductivity (—).
0 10 20 30 40 50Time, min
0.8
0
80
0
mS
/cm
AU Start of load
75 mM Tris, 250 mM NaCl, pH 8.0 (equilibration and wash)
75 mM Tris, 440 mM NaCl, pH 8.0 (pre-elution) 75 mM Tris,
1,000 mM NaCl, pH 7.5 (product elution)
100 mM acetate, 1,000 mM NaCl, pH 4.0 (strip)
Flowthrough Pre-elutionProduct collection
Conclusion
The final process yields an active, concentrated virus product with purity, HCP, and DNA levels comparable to clinical grade products. While the purification methods presented here were developed using the Ad5-E1+GFP model virus, they are expected to be applicable to recombinant adenoviruses in general, and to constructs derived from serotype 5 viruses, in particular. This efficient two-step purification process, Nuvia cPrime Mixed-Mode Resin followed by Nuvia Q Anion Exchange Resin, provided approximately 54% overall recovery of virus particles ( Table 1). This process is readily scalable and uses procedures and reagents compatible with cGMPs.
SDS-PAGE shows the progressive reduction of contaminating proteins at each step of our purification process (Figure 1). The five most prominent viral proteins — hexon, penton, core (V), hexon (VI), and core (VII) — are readily visible in the final purified product (Figure 1, lane 7).
Overall recovery of virus particles is approximately 54%, with DNA levels below detection and HCPs at 2 ng/1010 particles. These values are within current guidelines for clinical and possibly commercial use.
Abstract
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. These challenges mostly arise from the size and complexity of the virus. Here we present purification results of a cGMP-ready process developed for a recombinant adenovirus. The two-step column process results in an adenovirus preparation with high yield and very low host cell protein (HCP) and DNA contamination, comparable to clinical grade products. This process is readily scalable, simple, rapid, and efficient and is thus well-suited for the production of clinical grade viral vectors.
Fig. 1. Purification process results. Chromatograms from A, the mass capture and; B, the anion exchange steps; C, SDS-PAGE of intermediates and the final product. Lane 1, MW marker; lane 2, Nuvia cPrime load; lane 3, Nuvia cPrime flowthrough; lane 4, Nuvia cPrime elution/Nuvia Q load; lane 5, Nuvia Q flowthrough; lane 6, Nuvia Q pre-elution; lane 7, Nuvia Q product. OD 260 (—); OD 280 (—); conductivity (—).
Development of a cGMP-Ready Purification Process for Adenovirus Purification
A. Nuvia™ cPrime™ Resin
AU
B. Nuvia™ Q Resin
0 10 20 30 40 50Time, min
1.0
0.8
0.6
0.4
0.2
0
120
100
80
60
40
20
0
AU
mS
/cm
Flowthrough Pre-eluate Eluate
Strip
mS
/cm
0 40 80 120 160 200 240 280 320Time, min
2.6
2.2
1.8
1.4
1.0
0.6
0.2
120
100
80
60
40
20
0
Flowthrough
Eluate
Strip
C. Purity analysis of intermediates and final product
1 3 4 5 6 7
250
150100
75
5037
25201510
Hexon
PentonCore (V)
Hexon (VI)Core (VII)
2
Table 1. Viral particle recovery and impurity clearance.
SampleTotal virus
(x1011 particles)
Impurity levels (ng/1010 particles)
DNA HCP
Bulk harvest 30.6 3,144 n/d
Nuclease-treated harvest 31.8 30 3,022
Nuvia cPrime eluate 18.4 n/d 58
Nuvia Q eluate 16.4 <0.02 2
n/d, not determined.
Fig. 2. Behavior of the crude harvest on the Nuvia Q Column. OD 260 (—); OD 280 (—); conductivity (—). Blue shading indicates detection of significant transgene expression.
Introduction
Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. They offer several advantages including the capacity to accommodate up to 37 kb of foreign genetic material, very high infection efficiencies, the ability to infect a wide variety of both dividing and nondividing cell types, lack of integration into the host chromosome, and production systems capable of generating high virus titers. A two-column cGMP-ready purification process was developed for a recombinant adenovirus. We show that the final process yields an active, concentrated virus product with purity comparable to clinical grade products.
Process Development
Mass CaptureProcess developers seek high recovery and purity during initial capture. Affinity capture is usually not an option for the downstream processing of recombinant proteins, viruses, and second generation mAb-like proteins. The mixed-mode resin, Nuvia™ cPrime™, was chosen for initial capture because of its ability to quantitatively bind the virus, provide high recovery of active material, and clear DNA. Using a mixed-mode resin for capture enhances selectivity and delivers increased total protein recovery and purity. A nuclease digestion was introduced prior to column loading.
Anion Exchange ChromatographyThe anion exchange resin, Nuvia Q, was selected because it could adsorb virus at the higher sodium chloride concentration used during Nuvia cPrime elution (Figure 2). It was therefore easier to work with downstream of the Nuvia cPrime capture step, where the eluate had a sodium chloride concentration of approximately 500 mM going on to the anion exchange column.
0 10 20 30 40 50 60
Time, min
0.8
0.6
0.4
0.2
0
100
80
60
40
20
0
mA
U
mS
/cm
Nuvia Q
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THE effects of sample preparation will be discussed in terms of the removal of some targeted analytes, which are known to cause detection issues with
mass spectrometry, the detector of choice for many bioanalytical laboratories. Effective sample pre-treatment of a biological fluid – as well as removing problem endogenous components – can be used to increase the sensitivity of the assay by pre-concentrating the final extract, as well as improving the performance of the instrumentation, resulting in improved lifetimes of consumable items and improved robustness of the detectors.
The nature of the compound under investigation can be exogenous or endogenous, with the nature of the biological fluid also being very varied, ranging from urine and bile, to more complex fluids such as blood and cerebrospinal fluid.1-3 The nature of the biological matrix presents the greatest challenge within bioanalysis. This is often referred to as matrix effects, as it causes issues with selectivity and specificity, which ultimately affects the sensitivity and robustness of the assay. It is used in a variety of contexts including pharmacokinetic studies,4 metabolism studies,5 and also metabonomics.6 Depending on the nature of the analysis, different sample preparation techniques are favoured, thus an approach which is suitable for a single compound determination in a biological fluid may not be suitable to identify a particular metabolic biomarker using a metabonomic approach.
The current approaches to sample pre-treatment include:
The most common approach for blood and plasma samples is the addition of a chaotropic reagent to the biological fluid, resulting in the precipitation of the proteins. The chaotrope is typically acetonitrile, although other organic solvents and a range of acids can also be used. The choice of chaotropic reagent is dependent on a range of factors, with the primary consideration being financial. However, different chaotropes can have different effects on proteins since they affect different parts of a protein structure, resulting in slightly different mechanisms for the denaturing of the protein molecule.7
So-called ‘matrix effects’8-10 are well recognised for their potential to distort analytical data if not properly controlled, and are discussed in method validation in relation to the effect that the matrix has on a compound(s) response. These matrix effects arise because of the complexity of biological fluids, which contain many thousands of different compounds with a broad range (>107) of concentrations.11 Each of the endogenous compounds present in biofluids vary from sample to sample,12 with many of these compounds being ionisable under the conditions used for mass spectrometry resulting in them either:
● Competing for the available charge in the ion source of the mass spectrometer13
● Enhancing the ionisation capabilities of other compounds14
● Reducing in solvent evaporation.15
Other processes16 can also cause variable responses from the mass spectrometer.
The variability in matrix composition potentially means that the degree of ionisation will vary from one sample to another with possible adverse effects on the analysis of target analytes. It can therefore
Sample preparation – is it possible to have too much?
In the field of bioanalysis, the use of sample preparation is fundamental to ensuring that data is robust. This article looks at some of the various forms of sample preparation that are commonly used for the pre-treatment of biological fluids and considers the advantages and disadvantages of each approach.
Tony EdgeAgilent Technologies
TONY EDGE is an R&D Manager at Agilent Technologies, heading a team of specialist scientists in developing next-generation stationary phases for HPLC. In 2008, he was awarded the Desty memorial lecture for his contributions to innovating separation science, and in the same year also won a clinical excellence award from AstraZeneca. Dr Edge was awarded an honorary fellowship at Liverpool University, where he lectures on separation science, and also lectures at Keele University on Management in Analytical Science. He is the President of The Chromatographic Society in the UK and a permanent member of the scientific committee for the International Symposium on Chromatography.
IN-DEPTH FOCUS | SEPARATIONS & PURIFICATIONS
2@PharmaReview
be critical that the compound is resolved from any endogenous materials to reduce or eliminate the effects of ion suppression within the mass spectrometer source.
Measuring extraction performancePhospholipids are one of the classes of compounds often monitored as a measure of the performance of the sample extraction procedure being employed.17 These compounds are a class of lipids that form a major component of all cell membranes. They can form lipid bilayers due to their amphiphilic characteristic. The structure of the phospholipid molecule generally consists of two hydrophobic fatty acid ‘tails’ and a hydrophilic ‘head’ consisting of a phosphate group. The phosphate head has a very characteristic fragment ion at m/z 184 and, due to the high concentrations generally present in blood and plasma, this fragment ion is readily seen, even if the source conditions have not been optimised. If a tandem mass spectrometer is being used, then a range of phospholipids can be sought. Table 1 highlights five characteristic phospholipids that have been used to monitor the performance of the extraction technique.
The ever-increasing number of samples, particularly in the field of bioanalysis, and the introduction of chromatography coupled to mass spectrometry, has meant that typical chromatographic run times are as little as two to three minutes, with average injection to injection analysis times routinely less than 10 minutes. In general, compounds of interest are eluted from the column under gradient conditions, with acetonitrile being the strong elutropic solvent and formic acid added to aid ionisation. The chromatography is optimised for the compounds under investigation, and it is common for other components not to be monitored when developing the chromatography. This makes quantification substantially easier, and the use of tandem mass spectrometry aids this process, as it effectively reduces what should be a very complex chromatogram to very few peaks. This presents a substantial challenge because when using other forms of detection, such as UV, it is trivial to determine if all the components injected onto the column have eluted. This presents an extra degree of complexity for bioanalytical scientists, since not only will each sample have different matrix effects, potentially the order in which these compounds are analysed will also have an effect on the determination of the concentration of the target compounds.
As an example of this, 100µL of rat plasma with EDTA anticoagulant was used as the matrix. 300µL acetonitrile was added to the rat plasma and vortex mixed. Since the experiment is focusing
on the removal of matrix, no analytes are spiked into the sample. The precipitated proteins were then removed by centrifugation at 10,000g for 15 minutes. Subsequently, the supernatant was transferred to a 2mL vial and evaporated to dryness under a constant stream of nitrogen at 40°C and finally reconstituted with 100µL of water-methanol-formic acid (95:5:0.1 v/v/v).
The resulting sample was analysed using LC-MS. The mass spectrometer was used to monitor the five phospholipids listed in Table 1. All of these compounds have the same phosphocholine daughter group, which has a characteristic mass of 184.3, with the parent masses being: 496.4; 524.4; 704.4; 758.4 and 806.4 respectively.
A C18 silica-based column was used in all cases (50mm x 2.1mm). Mobile phases were 0.1% formic acid in water [A] and 0.1% formic acid in methanol [B]. A gradient programme was employed for the analysis and was designed to reflect that used in many bioanalytical laboratories. The initial composition of 95% [A] and 5% [B] was held for 0.5 minutes, then a linear gradient was applied, increasing the concentration of [B] to 95% in three minutes. This composition was held for one minute,
FIGURE 1
ABOVE: Normalised detector response for phospholipids in 10 water injections subsequent to an injection from a protein precipitated extract. Phospholipid m/z transition labelled. Modified from ref 3.
FIGURE 2
BELOW: Detector response obtained for the extract using different sample preparation techniques, PPT – protein precipitation, SLE – support assisted liquid-liquid extraction, Hydrophobic SPE, Mixed mode SPE CX. Modified from ref 3.
EUROPEAN PHARMACEUTICAL REVIEW | Volume 22, Issue 05
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then changed to the original starting conditions of 95% [A] and 5% [B], where it was held for a further 0.5 minutes. A constant fl ow rate of 0.6mL/min was employed, with an injection volume of 10µL. This arrangement gave an injection to injection time of approximately fi ve minutes.
Subsequent to the extracted plasma sample, a series of aqueous injections was performed. Phospholipids are not present within the aqueous sample and detection would be due to the incomplete elution of the phospholipid during the previous chromatographic run. Figure 1 shows the detector response obtained for a series of injections of water subsequent to the fi rst injection of a protein precipitated plasma extract. Figure 1 shows that, in general, the less lipophilic phospholipids are eluted from the column quicker than the more lipophilic phospholipids. However, with consecutive aqueous injections the more strongly retained, heavier phospholipids are gradually eluted from the analytical system. Figure 1 clearly demonstrates one of the challenges associated with the short analysis times typically employed in bioanalysis, as it is evident that the heavier phospholipids have not eluted from the HPLC column on the fi rst injection and that it takes
TABLE 1 Some commonly tracked phospholipids used to determine the performance of matrix removal
PHOSPHOLIPIDS MONITORED Q1 MASS (ATOMIC MASS UNIT) Q3 MASS (ATOMIC MASS UNIT)
several injections to remove these compounds from the column. The data here suggests that, under commonly used bioanalytical chromatographic conditions, traces of phospholipids will remain even after 10 injections of a pure aqueous solution.
Comparing modes of sample preparationThe mode of sample preparation can also have a signifi cant eff ect on the removal of endogenous components. Figure 2 shows data obtained from four diff erent extraction procedures: a polymeric hydrophobic SPE; mixed mode cation SPE; support assisted liquid extraction; and protein precipitation. The experimental detail for each of these approaches is given below.
A polymeric SPE media in a 30mg/1mL cartridge was conditioned with 1mL of methanol followed by 1mL of water. 100µL of plasma was diluted to 1mL in water and loaded onto the cartridge. A generic wash using 1mL of 5% methanol in water was employed, although if the wash protocol was optimised for a particular set of compounds this value could vary for a real assay. The elution was performed with two aliquots of 500µL of methanol.
A 30mg/1mL mixed mode cation exchange cartridge was conditioned with 1mL 0.1% formic acid in methanol followed by 1mL 0.1% formic acid in water. 100µL of plasma was diluted to 1mL in water with 0.1% formic acid and loaded onto the cartridge. The cartridge was then washed with 1mL 0.1% formic acid in water and then 1mL 0.1% formic acid in methanol. The elution was performed by applying two aliquots of 500µL of methanol with 5% ammonia solution added.
All SPE eluants from the elution step were collected and evaporated to dryness under nitrogen at 40°C then reconstituted with 100µL of water-methanol-formic acid (95:5:0.1 v/v/v). In all the SPE procedures, positive pressure was applied to the cartridges using a 50mL plastic syringe with a cartridge adaptor attached. This allowed accurate control of the fl ow rate of the solvents through the cartridge.
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CPhI Worldwide returns to Frankfurt this OctoberCPhI Worldwide will host more than 42,000 pharma professionals and more than 2,500 exhibitors over three days at the Messe Frankfurt, Germany. The event is the most effective way to establish new business relationships, meet with global partners and stay up-to-date with the latest industry trends.
THE 28th CPhI Worldwide returns in a year where global growth across the pharmaceutical industry is flourishing. It is a particularly strong time for outsourcing and ingredients, as well as an incredibly buoyant time for the pharmaceutical manufacturing industry. In fact, the global CDMO market is predicted to enjoy a 7.5% compound annual growth rate (CAGR) over the next three years, with the global API market forecast to grow from $158.3bn at the end of 2017 to $225.2bn by 2025.
There is also a renewed confidence in the North American pharma market, with the three hotbeds of biotechnology – San Diego, San Francisco and Boston – experiencing a
notable resurgence. CPhI Worldwide itself is in many ways the global barometer of the industry’s overall health, and earlier this year we saw the launch of the inaugural CPhI North America. This new event, held in the world’s foremost pharma economy, represented a natural progression for the CPhI brand and was extremely successful.
But this year has seen many exciting developments throughout the globe, with the new Marketing Authorisation Holder (MAH) pilot in China providing huge innovation opportunities for Chinese biotechs and generics expanding from Japan, USA and Europe to the emerging markets. In addition, all of our global events have seen
a surge in the number of bio and finished formulations attendees, again highlighting how strong these markets are.
But it’s not just about numbers, and from the attendees and exhibitors we speak to, there’s a real confidence about both the short and median-term prospects. But essential in maximising your potential are the partnerships you make this week. Our event has become an essential conduit through which future industry growth is secured.
It’s a truly dynamic time for the global pharma industry, and CPhI Worldwide provides an opportunity to come together and focus on the latest trends, technologies and insights. Above all, it is a platform for the industry to drive forward new partnerships, do business and grow.
Event overviewCPhI Worldwide will take place on 24-26 October 2017 at the Messe Frankfurt, Germany. After last year’s record-breaking event, the world’s most prominent pharma executives are ready to gather again for three days of collaboration, information dissemination, and discussions that will define the future of the industry.
The 2016 CPhI Worldwide event in Barcelona saw an all-time record attendance of over 42,000 people, with 2,550-plus exhibitors from 156 countries. Building on this success, CPhI Worldwide 2017 will host over 20 dedicated zones covering
24-26 OCTOBER
FRANKFURT, GERMANY
CPhI will host more than 42,000 pharma professionals
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European Pharmaceutical Review is pleased to support the following show partners, who will be at CPhI Worldwide 2017:
Abbie – Stand 41M11Constantia – Stand 24H51Datwyler – Stand 42D10Thermo Fisher Scientific – Stand 40K22
Welcome to European Pharmaceutical Review’s Show Preview of:
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ISSUE
03 2017JUN
europeanpharmaceuticalreview.com
In partnership with the pharma industryEUROPE ANRE VIEW
PHARMACEUTICAL
IN THIS ISSUE
Subvisible particle identifi cation in protein-based
formulations using Raman spectroscopy
The regulatory acceptance of rapid microbiological
methods: a roundtable discussion summary
How two-dimensional liquid chromatography is
used in an analytical troubleshooting laboratory
Formulation & DeliveryFormulation & Delivery
An In-Depth Focus that includes an investigation into freeze-dried
formulations, a review of mucosal drug delivery, and a profi le of
analytical techniques for faster development of delivery systems
Coming up in the October issue of EPR
Distributed at
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DATWYLER Sealing Solutions is a leading industrial supplier for global market segments and a key player in the healthcare world, building on over 100 years of experience. Datwyler offers state-of-the-art solutions for drug packaging, drug administration and medical devices.Based on its profound knowledge of the industry and future challenges for clients, Datwyler has developed a new strategy for the healthcare segment combining global knowledge and local manufacturing expertise. With three standardised offering categories, Datwyler provides the highest transparency and outstanding products for its clients: Bio Care for the most sensitive, large molecule drugs; Pharma Care for small molecule drugs that require production fl exibility and outstanding quality; and Med Care with a broad range of materials and technical support for medical companies.
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Stand Number: 42D10
EUROPEAN PHARMACEUTICAL REVIEW | Volume 22, Issue 04
ABBVIE Contract Manufacturing has been serving our partners for more than 35 years across 10 of our manufacturing facilities located in both North America and Europe. Our contract development and manufacturing capabilities span both small and large molecule API, including classical fermentation, chemical synthesis and biologics.In addition to APIs, we are offering extensive experience and technical solutions in the area of drug product manufacturing, which includes traditional tablet and capsule production with emphasis on DEA controlled drugs, potent and hot melt extrusion. Lastly, we can also package your product regionally and offer prefi lled syringe manufacturing capabilities.
By choosing AbbVie Contract Manufacturing, your team gets so much more than the typical CMO engagement. Alongside our state-of-the-art cGMP manufacturing facilities, AbbVie’s partners gain integrated access to deep scientifi c expertise and processes that have successfully supported many small molecule and biologic medicines through to commercialisation.
Information about AbbVie contract manufacturing services can be found at abbviecontractmfg.com or by reaching us directly at 1-847-938-8524. We look forward to serving you.
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Stand Number: 41M11
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ISSUE
03 2017
JUN europeanpharmaceuticalreview.comIn partnership with the pharma industry
EUROPE AN RE VIE WPHARMACEUTICAL
IN THIS ISSUE
Subvisible particle identification in protein-based formulations using Raman spectroscopy
The regulatory acceptance of rapid microbiological methods: a roundtable discussion summary
How two-dimensional liquid chromatography is used in an analytical troubleshooting laboratory
Formulation & Delivery
An In-Depth Focus that includes an investigation into freeze-dried formulations, a review of mucosal
drug delivery, and a profile of analytical techniques for faster
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14
The FDA has increased warning
letter distribution dramatically
in recent years. Notably,
there has been a significant
increase in the number of
warning letters referring to
‘data integrity’ and ‘sterility
assurance’, in relation to
environmental monitoring (EM).
Sign up for this webinar
to learn about trends in
regulatory warning types
and the new measures
inspectors are indicating
that they want implemented
in controlled environments.
Gilberto Dalmaso, PhD, Senior
Advisor and Pharma Customer
Advisory Team Manager
at Particle Measuring
systems, will provide specific
recommendations on
avoiding 483s.
Dr Dalmaso has over
25 years’ experience in
pharmaceutical microbiology
and sterility assurance.
In 2006, he was awarded
an honorary PhD in
Pharmaceutical Microbiology
from Università degli Studi di
Milano in recognition of his
innovative microbiological
scientific studies and new
technologies introduced to
the pharmaceutical industry.
Today, he is a reporter
to numerous symposia
on microbiology and the
pharmaceutical industry in
Europe and United States.
Improving aseptic
processes and monitoring
to reduce FDA 483s
and warning letters
In this webinar, Gilberto Dalmaso, from
Particle Measuring Systems, will explain how to
maintain environmental monitoring standards
to avoid warning letters from the FDA.
REGISTER NOW
europeanpharmaceuticalreview.com/webinars
IN ASSOCIATION WITH:
4 OCTOBER 2017
15:00 BST
WEBINAR PREVIEW | PARTICLE MEASURING SYSTEMS
epr417 PMS Webinar.indd 14
11/10/2017 12:06
14
MEDIA P L A N N ER
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How does it work?
The fi ndings of a survey will give you independent, empirical data which can be used to inform and shape strategy and/or reinforce the benefi ts of your product/service; this acts as a key diff erentiator in an increasingly competitive market. Each project we undertake is customised to your requirements.
The Question Set
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Analysis
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Purpose and Scope of the Project
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Surveys & Research
3
5
1 2
4 6
15
Content Calendar
IN-DEPTH FOCUS
NIR Biopharma Processing & Development Raman Environmental Monitoring Spectroscopy Raman
Mass Spec Microbiology Separation & Purifications Biopharma Processing & Development Microbiology Formulation, Development & Delivery
Packaging Formulation, Development & Delivery Manufacturing QA/QC Ingredients Biopharma Processing & Development
Making Pharmaceutical Europe 2018 Making Pharmaceutical 2018 bioLIVE 2018
DDF Congress 2018 ASMS 2018
ISPE Europe
SUPPLEMENT Guide to Analytical Testing Equipment Guide to Testing Scientific Poster Gallery 2019 Guide to Manufacturing Guide to Single Use Guide to Outsourcing App Note & White Paper Supp
Aseptic Processing PAT Microfluidics Freeze drying Laboratory Informatics
EVENT PREVIEWS
PITTCON 2019 CPHI NA 2019 Making Pharma Milan 2019 CPhI worldwide 2019 Pharmapack 2020
INTERPHEX 2019 Making Pharmaceutical 2019 SCIX 2019 ISPE 2019
ISPE Europe 2019 ASMS 2019 bioLIVE 2019
Global DDF Congress 2019 HPLC Europe 2019
SUPPLEMENTGuide to Analytical Testing Equipment Guide to Testing Guide to Informatics Guide to Single Use Guide to Outsourcing App Note& White Paper Supp
Scientific Poster Gallery 2019
EVENT BONUS DISTRIBUTION
PITTCON 2019 CPHI NA 2019 Making Pharma Milan 2019 ISPE 2019 Pharmapack 2020
INTERPHEX 2019 Making Pharmaceutical 2019 SCIX 2019 CPhI worldwide 2019
