Microbial from early development to commercialization

the next level in microbial...

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Microbial from early development to commercialization

Biomanufacturing began with microbial processes. Now new developments in antibody fragments, scaffolds and bioconjugates are renewing interest in this field. However, some of the emerging microbial processes require specialized manufacturing capability and a highly skilled workforce to achieve cost-efficient and reliable production. Your existing infrastructure and technology may not be a good fit for new drug candidates. Outsourcing is relevant as it releases pressure on your organization and allows you to delay or even avoid high-risk investments in specific manufacturing capacity. The right partner can help you navigate the microbial field by balancing investment and timeline risks with market opportunities.

individual microbial strains

3K

we’ll reach it together

Our offer

At Lonza Pharma & Biotech, we believe that if you want to deliver the future, you need to shape it.

We actively monitor drug-candidate pipelines and follow innovation trends. The insights we acquire help us create flexible service models and invest in advanced technologies and skillsets for the development and manufacture of new medicines.

Our broad microbial service portfolio enables you to define your own tailored solution from a complete set of services. We have extensive experience. Our toolbox contains well- established technologies for efficient, scalable and regulatory-compliant processes.

When you are ready to go from clinical development to commercialization, we can provide supply security. You can integrate our complementary analytical and regulatory services into your solution to de-risk your path to approval. We can help reduce risk in the launch phase by building customized facilities for your specific manufacturing needs.

Why Lonza

Process optimization for better process economyWe can optimize existing fermentation and purification processes to improve manufacturability and process economy, no matter what your development stage or expression platform. Our scientists and engineers have the deep technology skills required to help you solve challenges where others may struggle, specifically in areas of solubility, productivity, product quality and stability.

Full flexibility in development and manufacturingThe services and equipment we offer are fully flexible and always phase appropriate. We keep your ultimate goal in mind but focus on the next milestone so that we are always in sync with your needs. You can mitigate investment risk by partnering with us in flexible business models that provide supply solutions for different market demands.

Easy access to powerful and proven technologies Our service packages and licensing agreements give you access to an extensive technology toolbox with a collection of proprietary, highly productive and scalable microbial platforms that enable high-yield processes for a wide variety of molecules. This toolbox is developed with manufacturability in mind. The necessary documentation is already in place to facilitate regulatory approval.

Agile approach without compromiseOur solutions are tailored to short timelines without compromising the manufacturability of your process. In our microbial Center of Excellence in Visp, Switzerland, development and manufacturing teams work in close collaboration to ensure seamless transitions between project phases. Each project is assigned to a dedicated Project Manager, which means a single point of contact for you.

Knowledge sharing for long-term growthWhen you work with us, you have access to more than 30 years’ experience in the microbial biopharmaceutical field. Our approach is based on teamwork and knowledge sharing. You benefit from our insights into best practices for commercializing microbial processes. You can merge these insights with your own knowledge and derive long-term benefits.

Access to capabilities

Technology is at the core of our microbial offering. Our XS Technologies® platform includes Escherichia coli, Pichia pastoris and Bacillus subtilis expression systems. In our labs we routinely see productivities of up to 20g/L for less complex therapeutic proteins, above 5g/L for novel scaffolds and up to 600mg/L for pDNA. Our XS Technologies® are available for third-party use under a research license or commercial license.

Specific services that enhance our microbial offering include Light Path™ protein-production services to help reduce the time to IND filings, development of cGMP-compliant master and working cell banks, analytical development with a wide range of testing expertise in microbial products, and drug-product development services for oral and parenteral formulations. We offer extensive validation support to streamline your regulatory approval process. You can also contract us for regulatory consulting with our in-house network of experts.

Our microbial drug substance manufacturing solutions are based around our microbial Center of Excellence in Visp, Switzerland. Visp has a manufacturing capacity up to 2 x 15,000L and BSL-2 capabilities at all scales. If you are looking to expand your own capacity, we have the engineering expertise and financial strength to help you with new builds. One example of our innovative approach is Ibex Solutions™, a modular facility for responsive capacity, which saves your company time and investment.

We have experience within our network to develop, optimize and manufacture cross-technology medicines. Examples of our capabilities include conjugation technology and expertise within small molecules. The result is an integrated solution for complex medicines, so you can simplify your sourcing process and get to market faster.

For difficult-to-express proteins, the XS™ Portfolio has delivered expression levels of up to 1g/L, where alternatives only achieved a few mg per liter.

Productivities of up to

20g/L

XS Technologies® is a registered trademark in Switzerland.

The XSTM Toolbox has complementary options to meet all your expression needs

XS Expressions SystemsTM E.coli Pichia Bacillus

High titers Yes Yes Sometimes

Expresses Next-Gen Therapeutics Yes Yes No

Soluble expression Yes Yes Yes

Stable Yes Yes Yes

Scalable Yes Yes Yes

Secretes product Sometimes Yes Sometimes

Short fermentation times Yes Yes No

Endotoxin free No Yes Yes

Glycosylation capabilities No Yes No

Species approved by FDA Yes Yes No

From gene to API production in around

Max fermenter capacity 2x

12 months

15KLresulting in a scalable and robust process

We add value to your drug development process

Our microbial capabilities range from early-phase developability assessments through to large-scale commercial manufacturing services. Whatever your needs, we provide tailored solutions for you and minimize risk, time, cost and complexity.

Developability assessment

Strain development

Pre-clinical production

Early-stage development Late-stage development Commercial

Analytical method validation / stability studies

Regulatory consulting to support IND and BLA

Agile development

De-risked manufacture

Flexible supply

Optimized path to filing

Clinical production Commercial production

Process lifecycle managementProcess characterization / validation

Cell banking

Manufacturing process development

Analytical method development

Manufacturing process optimization

Analytical method optimization

Global network to support your microbial programs

API development and manufactureDrug product intermediate and drug product development and manufactureR&D centers

Edinburgh, Scotland

Cambridge, UKBornem, Belgium

Visp, SwitzerlandMonteggio, Switzerland

Tampa, FL

Ploërmel, France

Quakertown, PA

Bend, OR

Colmar, France

Contact usUSA +1 201 316 9200 Japan +81 (0)3 6264 0600 Europe & Rest of World +41 61 316 81 11 Email microbialbiopharma@lonza.com

pharma.lonza.com

30years’ experience in the microbial biopharmaceutical field

The information contained herein is intended for general marketing purposes only. While Lonza makes efforts to include accurate and up-to-date information, it makes no representations or warranties, express or implied, as to the accuracy or completeness of the information provided herein and disclaims any liability for the use of this publication and that all access and use of the information contained herein are at their own risk. Lonza may change the content of this publication at any time without notice but does not assume any responsibility to update it. ©2017 Lonza. All rights reserved.