Our science Your success

Contents 3 Introduction

4 About Solvias

5 A company-wide quality culture

6 People at the heart of science

8 Specialized expert analytical solutions

10 Biopharmaceutical analysis

12 Cell and gene therapy

14 Solid state development

16 Quality control release and stability studies

18 Functional and biological analysis

20 Catalysis technology and specialty products

22 Custom synthesis and manufacturing

24 Process analytical technology

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Karen J. Huebscher Chief Executive Officer

Solvias is entering into a new era of growth and expansion as we continuously put science at the heart of our customers’ success.

Thanks to our partnership with strategic health care investors, Water Street Healthcare and JLL Partners, we are building the company into a global leader of high-quality pharmaceutical laboratory services.

Our innovation engine is primed and our expanded workforce poised to support the research and development of new drug substances, along with the optimization of manufacturing processes for pharmaceutical, biotechnology and life science companies worldwide.

Now more than ever, we are confident that Solvias has a solid basis for a sustainable future: delivering solutions to help our customers bring safer and better products to the market faster.

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About Solvias

Solvias is a world leader in contract research, development and manufacturing. Our name is derived from the Latin terms ‘solutio’ and ‘via’, embedding our promise to explore new ways to find solutions that surpass our customers’ requirements.

For over 20 years, Solvias has been an essential link in the value chain for our customers across the pharmaceutical, biotech, medical device and cosmetic industries. Our comprehensive portfolio of integrated services and solutions backed by professional project management spans all stages of drug development including custom synthesis of drug product.

Beyond our expertise in small molecules, we have built a solid reputation for the characterization and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. These cutting-edge capabilities enable Solvias to address the complex challenges of advanced therapeutic medicinal products (ATMPs): vaccines, cell and gene therapeutics, as well as nucleic acid-based products.

The Solvias Group has its headquarters and main laboratories in Kaiseraugst, Switzerland, and complementary facilities in Basel forming a hub with its site for specialized biological analyses at Confarma in Hombourg, France. As a science-driven service organization with a company-wide quality culture, more than 500 highly qualified employees take pride in delivering unrivalled expertise, service and value according to our core values of respect, responsibility and reliability. Our laboratories operate to the highest quality standards in accordance with ISO, GMP, GLP and FDA regulations.

We invite you to learn more about Solvias and our full spectrum of analytical capabilities and solutions.

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WE CONTINUE TO EXPAND AND EVOLVE OUR COMPANY-WIDE QUALITY CULTURE.

A shared commitment to quality is the foundation that enables Solvias to be an essential link in the research, development and manufacturing processes for our customers. These include some of the world’s largest pharmaceutical and medical device companies, as well as smaller biotechs and contract manufacturing organizations.

We strive to instill knowledge of good manufacturing practices (GMP) at every level of the organization and contribute to the Solvias onboarding program to ensure that all new employees share a foundational understanding of our company, its customers and the industry’s regulatory practices and systems.

Our Quality Unit for the Solvias Group monitors ongoing processes, prepares for audits/inspections, supports colleagues on how to further improve and strives to embed a quality mindset in everything we do. Internal audits are performed to learn from these findings in order to fine-tune our processes. In addition, we are regularly audited by our customers.

A company-wide quality culture

ADHERING TO THE HIGHEST STANDARDS

Solvias is regularly inspected by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Swissmedic.

In addition to ongoing ISO certifications, Solvias AG adheres to GMP standards in accordance with the Pharmaceutical Inspection Cooperation Scheme and the directives of the European Commission.

Confarma, our specialized biological analysis unit in Hombourg, France, offers services according to GMP, GLP, ISO 17025, ISO 9001, ISO 14001, and OHSAS 18001 standards. The site is authorized by the French health authority ANSM for compliance to GMP and GLP and accredited by COFRAC for compliance with ISO 17025.

ADDING VALUE FOR CUSTOMERS

The Solvias group is moving further into the future of quality assurance with MasterControl, our paperless quality management system. MasterControl enables us to harmonize quality systems across all our sites, retrieve crucial information faster, track key performance indicators in quality and offer online training to employees. This will enable us to fully align with the quality systems of our customers so as to offer them a seamless experience.

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People at the heart of science

As an expanding contract research and service company, our growth is powered by people with a passion for science.

Beyond the best scientific talent, we seek to hire and retain individuals who embrace our values and behaviors. A centralized onboarding program for new employees in

Switzerland helps ensure a common understanding of our company and its culture. This is enhanced by an additional

week of training three to four months after new employees start at Solvias to

provide a deeper understanding of our laboratory software

(LIMS), quality and good

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manufacturing practices (GMP), along with the conducting of audits. We also want to ensure a solid understanding of processes in our sales and support functions among other areas.

Our success is dependent upon highly qualified, engaged people who put their unique skills, experience and expertise to work for Solvias and its customers each day. With our central service hub in an area of Europe where the borders of France, Germany and Switzerland meet, our employees share a combination of languages and culture that gives our company a diverse, international touch. We strive to create an atmosphere where every individual can have an impact and grow both personally and professionally.

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Solvias values people who want to contribute to our shared success as a science-driven service

organization. This can be seen in the way we invest in our employees, from our onboarding program to continuous learning at all levels of our organization.

Marco Born Head of Human Resources

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A CULTURE OF CONTINUOUS LEARNING

Continuous learning is an important part of our culture. Personal development plans may include specific scientific topics, management training or general courses to improve communication and leadership skills. All Solvias employees involved in customer projects also receive foundational training in project management.

Dedicated project leaders in our professional project management office are trained to manage complex projects according to internationally recognized standards. Their role is to mobilize internal resources across our different areas of scientific expertise while coordinating tasks and tracking timelines in close collaboration with customers.

We continue our intensive company-wide journey to embed Lean culture and continuous improvement at all levels of the organization, from the implementation of shop floor management boards in our labs to the introduction of a paperless system to simplify employee access to HR services such as pension information.

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Specialised expert analytical solutions

Our experts in SEAS provide customized solutions to support the entire life cycle of drug development, from the early preclinical phase to clinical development and commercialization. They develop, validate and execute methods for raw materials, intermediates, active pharmaceutical ingredients (APIs) and drug products, along with packaging and, especially for biopharma, single-use systems.

We offer a range of services spanning development and validation as well as release tests using methods for elemental analysis, physico-chemical testing, and wet chemistry including titration. We also perform trouble-shooting, e.g. for unknown impurities (including quantification, structure elucidation) at trace level in complex matrices or in the context of particulate contamination of parenterals and solid dosage forms. We further complement these solutions with coupled analytical methods such as GC/MS/MS and accurate mass high resolution

LC/MS for extractables and leachables along with the quantification of genotoxic impurities.

A SINGLE POINT OF ACCESS TO A NETWORK OF EXPERTS

For our customers, Solvias offers a single point of access to a network of international experts. Interacting both within our group and through partners to fill any technology gaps, our customers benefit from state-of-the-art solutions tailored to the most demanding requirements. We are able to respond to regulatory challenges of all kinds by combining a broad scope of analytical techniques with expertise backed by decades of experience in the pharmaceutical, biotech, cosmetics, fine chemicals and animal health industries.

Solvias helps customers optimize the time required to bring pharmaceutical innovations to market with a comprehensive range of specialized expert analytical solutions (SEAS) fully aligned with the latest regulatory requirements, GMP and ICH guidelines.

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Leveraging complementary techniques for most applications, we offer optimized solutions to respond to our clients’ needs. Some examples are:

• Application of ion chromatography (HPAEC-PAD) within biopharmaceutical analysis for determination of glycans in complex matrices

• Device and drug-device interaction characterization for prefilled syringes and drug device combination products, e.g. with respect to extractables and leachables, silicone

coating, tungsten residues, glass testing, particulate characterization, and analytical formulation support

• Solid-state studies to ensure the optimal form of drug substance (DS) for development

• ICP-MS for elemental impurities and beyond, i.e. for speciation analysis by LC-ICP-MS coupling, isotope analysis, analysis of non-metals like phosphorous or sulfur, realizing very low LOQs in complex matrices, rapid screenings of large compound libraries or analysis of highly potent ADCs

• Determination of nitrosamines in DS and DP in answer to urgent regulatory requirements

No matter how complex or specific the analytical challenge, our experts in SEAS are dedicated to delivering a solution that is fit for purpose.

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Biopharmaceutical analysis

At Solvias, we understand the need to progress rapidly and cost-effectively at the early stage of drug development. From one central service hub in the Basel area, we provide longstanding expertise not only in physico-chemical and functional analysis, but also in analytical services around raw materials, process-related impurities (PRI), excipients, extractables and leachables, and trace analysis as well as container closure integrity tests (CCIT).

Working in close collaboration with our customers, from innovative biotech startups to major drugmakers and leading contract manufacturers, we apply our proven expertise to complex analytical challenges around the entire spectrum of biologics: monoclonal antibodies, antibody-drug conjugates (ADCs), glycoproteins, PEGylated proteins and peptides, biosimilars and vaccines as well as gene- and cell-based therapeutic drugs. We also provide DNA sequencing under GMP, cloning, qPCR technology and FACS expertise.

BIOLOGICS AND BIOSIMILARS: CGMP ANALYSIS SUPPORTED BY PROVEN EXPERTISE

Solvias offers a complete range of services in biopharmaceutical analysis including characterization studies, method development and validation, stability studies, quality control, and batch-release analysis under FDA current Good Manufacturing Practice (cGMP). All work is carried out in accordance with the International Conference on Harmonization (ICH) guidelines of technical requirements for the registration of pharmaceuticals for human use. Biopharmaceuticals can be fully characterized for the Chemistry and Manufacturing Controls (CMC) section of Investigational New Drug applications (INDs), New Drug Applications (NDAs) and Biologic License Applications (BLAs).

We harness proven expertise to facilitate faster market access for biopharmaceuticals and advanced therapeutic modalities such as cell and gene therapies. A complete portfolio of capabilities in biopharmaceutical analysis and functional assays enables Solvias to support our customers at every phase of the development process for large and complex molecules.

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Early assessment of a protein’s stability can be invaluable, even during preclinical development. For drug substances and drug products, all stability aspects can be monitored, including long-term and accelerated stability studies, in-use studies, short-term temperature excursion studies and forced degradation studies according to ICH guidelines Q5C and Q1B.

We support our customers and internal experts with innovation, both in technology and management techniques. We continuously expand our service portfolio to offer the latest advances: new CD instruments for secondary structure determination of proteins, additional UPLC systems, additional mass spectrometer (MS) capacity along with CE-MS, performance of native MS projects, improved data workflows for in-depth protein characterization, as well as particle characterization studies with micro-flow imaging for biopharmaceuticals. Complex projects are managed by a dedicated team of professional project managers to ensure efficient coordination and communication across all areas of expertise.

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Cell and gene therapy

Advanced therapeutic modalities offer huge potential for preventing and treating many diseases based on genes, tissues or cells. Solvias is uniquely positioned to support our customers with a full range of solutions to ensure the safety of ATMPs.

HUMAN GENE THERAPY

Gene therapy is a technique in which a functioning gene is inserted into a human cell to correct a genetic error or to introduce a new function to the cell. Genetic material is administered to modify or manipulate the expression of a gene product, either RNA or protein, or to alter the biological properties of living cells for therapeutic use.

Human gene therapy offers new hope for the treatment of rare diseases, genetic disorders, cancers and infectious diseases. Advances in genetic engineering and recombinant

viral vector development have resulted in several gene therapy products gaining approval.

Cell and gene therapies are part of the fast-growing field of advanced therapy medicinal products (ATMPs). Solvias brings deep expertise and long-standing experience with innovative biopharmaceuticals to offer our customers a full spectrum of solutions for the analytical development, characterization and release testing of ATMPs.

Type of gene therapy product Therapeutic principle

Plasmid DNA Circular DNA molecules can be genetically engineered to carry therapeutic genes into human cells

Viral vectors Viruses have a natural ability to deliver genetic material into cells, and therefore some gene therapy products are derived from viruses. Once viruses have been modified and their ability to cause infectious disease removed, these modified viruses can be used as vectors (vehicles) to carry therapeutic genes into human cells

Genetically engineered microorganisms (e.g. bacterial vectors)

Bacteria can be modified to prevent them from causing infectious disease and then used as vectors (vehicles) to carry therapeutic genes into human tissues

Human gene editing technology

The goals of gene editing are to disrupt harmful genes or to repair mutated genes

Patient-derived cellular gene therapy products

Cells are removed from the patient, genetically modified (often using a viral vector) and then returned to the patient

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CELL THERAPY

Cellular therapies contain cells or tissues which have either been manipulated to change their biological characteristics or which were not intended to be used for the same essential functions in the body. Tissue-engineered medicines contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue.

Cell therapies are an emerging therapeutic option that can be used to cure, diagnose or prevent disease. Recent advances in cell characterization, isolation and ex vivo manipulation, combined with a greater understanding of stem-cell biology, are enabling biotechnology companies to develop cell-based products with the potential to cure a variety of diseases and injuries.

OUR CELL AND GENE THERAPY SOLUTIONS

Cell and gene therapies require particular methods and experience so as to ensure their safety, identity, quality, purity, and strength as well as potency.

Solvias offers a comprehensive range of orthogonal analytical methods for ATMPs. Our cell and gene therapy building blocks include raw materials testing, cell culture media specific analysis and oligonucleotide analytics. For gene therapies, vector analytics covers the full range of AAV or LV release analytics, including vector aggregation monitoring, sequencing and transfection potency. For cell therapies, our analytical expertise includes cell culture and differentiation mimicking in-life cellular evolutions, process-related impurities testing, recombinant protein expression and functionality determination as well as specific potency assay development. We provide a full complement of release testing to ensure sterility and quality control (QC) for the absence of endotoxins, pyrogens and contamination.

We have experience and can support your advanced therapy development from early stage development (e.g. IND application) to commercial testing.

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Solid state development

The identification and selection of an optimal solid form can have a significant practical and commercial impact on drugs. Solvias provides an integrated approach to solid-state development – from systematic salt, co-crystal and polymorph screening to controlled scale-up of the crystallization process and quality control of the drug substance (DS) and drug product (DP) – complemented by a full range of physico-chemical studies.

In a well-designed salt/co-crystal screening process, the optimal composition is chosen quickly, based on parameters such as solubility, hygroscopicity, crystallinity, chemical stability and suitability for production. Toxicological aspects, as defined in the FDA GRAS list, as well as the intended application are the basis for selection of possible counter ions or co-crystal formers.

The aim of a polymorphism program is to identify and characterize new polymorphic forms, hydrates and solvates of a substance. We also seek to understand the relationships among the different solid phases so that an ideal form can be recommended for development. The Solvias polymorphism screening strategy has been optimized through decades of experience and is tailored to our customers’ needs. The

combination of our optimized screening strategies with cutting-edge, high-throughput technology and rapid analysis by x-ray powder diffraction (XRPD) or Raman spectroscopy provides the maximum information with the minimum amount of the valuable drug substance.

CRYSTALLIZATION TO COMMERCIAL SCALE: OPTIMIZING OUR EXPERTISE TO MINIMIZE RISK

Our crystallization development program leads to robust, reproducible and scalable crystallization processes that generate the desired crystalline form, size and shape. From process development to commercial scale, we collaborate closely to take full advantage of the broad know-how of Solvias Ligands & Specialty Products. The crystallization processes are scaled-up jointly to the kilogram scale; all critical parameters of crystallization downstream processes, such as drying, are defined for large-scale production. Customers are then provided with a data package allowing them to transfer our processes to commercial scale with minimized risk.

Solvias offers proven expertise in solid-state development backed by a deep understanding of science and decades of experience in the field. From preclinical development through manufacturing of the final drug product, we continuously expand our service offerings across the value chain to serve a growing customer base in Europe and the United States.

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Quality control of DS and DP with respect to solid form composition is critical for product quality and safety. Depending on the product and application, the team develops and validates methods from simple identity tests to sophisticated quantitative and limit tests for crystalline or amorphous fractions. Routine QC testing under cGMP can also be provided.

For more than 10 years, Solvias has supported the enforcement of the intellectual property rights of its customers. The combination of high data quality and state-of-the-art equipment with highly skilled experts guarantees the best possible results from investigations of samples that potentially infringe upon existing solid-state patents.

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Quality control release and stability studies

QUALITY CONTROL RELEASE TESTING

Solvias brings our customers a proven track record in the routine performance of QC analysis according to GMP quality standards for raw materials, excipients, API and drug products of various galenical forms (solids, semi-solids and liquids for oral, inhaled and injectable use) and packaging material (glass and plastic containers, rubber closures).

The team offers the flexibility of working according to either compendial methods (USP, Ph. Eur. and JP), Solvias proprietary methods or customer methods. We have experience in verification of compendial methods, transferring validated analytical methods from customer sites or validating directly methods at our site.

Release testing parameters typically address:

• IDENTITY identifications of ions and functional groups, chromatographic methods: HPLC, TLC and GC, spectroscopic methods: IR, UV

• STRENGTH AND PURITY chromatographic methods: HPLC, UHPLC, HPTLC and GC, titration

• QUALITY physico-chemical properties, water content, aerodynamic particle sizing (e.g. NGI for inhalers), galenical tests for all dosage forms, hydrolytic resistance of glass

• SAFETY limit tests of heavy metals and ions, residual solvents by GC

Fast, high-quality and cost-effective services: our quality control release and stability studies unit combines advanced quality control (QC) analysis with cutting-edge science to support our customers with a full complement of services and flexible working methods.

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STABILITY TESTING FOR ALL STAGES

Solvias is well equipped to provide stability testing for all stages of drug development. Our stability storage infrastructure includes sophisticated walk-in chambers, climate cabinets and an emergency backup for power breakdown.

All our processes are completed on one connected site to take advantage of a high degree of QC expertise, scientific dialogue and maximal sample preservation.

Regularly performed testing includes:

• Long-term stability studies according to ICH guidelines

• Ongoing and follow-up stability studies

• Comparability studies

• Stress tests, forced degradation

• Photostability testing according to ICH guidelines

• In-use tests, freeze-thaw cycles

• Excipient/API compatibility

• Interaction studies with primary packaging

We provide you with stability protocols and reports according to your needs. We can also help to develop stability indicated methods.

Standard conditions offered include: 25°C/60%R.H., 30°C/65%R.H., 40°C/75%R.H., 30°C/75%R.H., 5°C, 50°C or 60°C, -20°C, ≤-60°C; others available on demand.

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Functional and biological analysis

Customers appreciate our comprehensive and solution-oriented approach across all fields of microbiology. Working out of our state-of-the-art laboratories at Confarma, we offer highly specialized analytical services spanning microbiology, cellular biology, virology, toxicology and molecular biology, with particular expertise in sterile products and environmental analysis. We work according to GMP, cGMP (FDA), GLP and ISO 17025 standards.

Our labs deploy rapid microbiological methods (RMM) to support our customers with the most advanced technologies and deliver results faster, for example with our rapid sterility test in just five days. We also offer the flexibility of training at customers’ own sites for specific techniques. Our R&D department is able to provide development and validation of client-specific methods as well as alternative methods.

In addition to microbiology, our dedicated laboratories for molecular and cell biology enable implementation of methods using several techniques, all on one site. We also provide testing facilities most adapted to the testing of toxic compounds and environmental monitoring samples.

MICROBIOLOGY

• TESTING FOR STERILE PRODUCTS rapid sterility test, sterility test, bioburden, Container Closure Integrity Test (CCIT)

• TESTING FOR NON-STERILE PRODUCTS microbial limit test (MLT), challenge test

• ENVIRONMENTAL TESTING water analyses, mapping, microbiological identification, disinfectants

• SPECIALIZED STUDIES antibiotics, integrity testing, alternative methods

• CONSULTING AND EXPERT REPORTS mapping, risk analysis, expertise report, training

Confarma is the Solvias Group’s dedicated affiliate for biological analyses and its excellence center for Advanced Therapy Medicinal Products (ATMPs). Located just across the border in Hombourg, France, this specialized site in the Alsace region forms a hub with our headquarters in the Basel area.

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BIOLOGY, TOXICOLOGY AND CELLULAR BIOLOGY

• ENDOTOXIN AND PYROGEN TESTING endotoxins (all methods including alternative method Recombinant Factor C), monocyte activation test (MAT), an in vitro pyrogen test

• CELL-BASED BIOASSAYS in vitro assessment of potency, stability and safety

• IN VITRO ASSAYS cytotoxicity, genotoxicity, ELISA, proteins

• CONSULTING AND EXPERT REPORTS risk analysis, expert reports, training

CHEMISTRY

• TESTING FOR STERILE PRODUCTS particle size, glide and break-loose force determination

• TESTING FOR HERBAL PRODUCTS pesticides

• ENVIRONMENTAL TESTING cleaning validation, total organic carbon, total hydrocarbons

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Catalysis technology and specialty products

For two decades, the catalysis team at Solvias has been at the forefront of innovation in the development of catalytic processes. We have begun exploring chemocatalysis as a tool of green chemistry to support more sustainable processes, and recently extended our portfolio to integrate catalysts for photoredox catalysis and C-H activation.

Flexible high throughput experimentation (HTE) arrangements, using the Symyx workflow based on dedicated 96-well plates, allow the team to identify optimal catalysts and conditions for customers’ reactions and substrates. Solvias uses the HTE platform to find leads for asymmetric transformation, C-X coupling, heterogeneous hydrogenation and miscellaneous catalytic reactions that can be adapted to HTE protocols. Leads obtained from HTE projects can be seamlessly optimized and developed by our experts, culminating in a technology transfer to the client or kg scale-up in Solvias laboratories.

Separation of racemic mixtures by the formation and crystallization of diastereomeric salts (chiral resolution) is an important technology in the pharmaceutical industry. Solvias offers HTE-assisted evaluations using a large variety of chiral acids and bases. Applying this methodology, Solvias has successfully resolved a large number of chiral customer compounds. Close interaction with our solid state department allows for further in-depth analyses towards scalable processes.

A WORLD-LEADING LIGAND PORTFOLIO FOR CATALYTIC TRANSFORMATIONS

Solvias has built one of the largest proprietary ligand portfolios in the world to further support our customers’ catalytic transformations. The portfolio consists of a variety of families of chiral phosphine ligands for stereoselective catalytic reactions, achiral phosphines and catalysts that can be utilized for C-X coupling (e.g. the cataCXium ligand families) as well as chiral phosphoric acid catalysts for use in organocatalytic transformations. Based on in-house development and licensing, all ligands and catalysts in the Solvias portfolio are readily available for commercial-scale applications and are sold IP included. Their performance (quality, chemical stability, ease of handling, safety) and supply chain meet all applicable pharmaceutical industry requirements.

Solvias has an outstanding track record in the successful implementation of catalysis technology as well as the production of ligands and other specialty products. We support our customers with a library of over 700 ligands while pursuing extensive research and development efforts with leading universities and external scientists to tackle the most demanding projects in the field of homogeneous and heterogeneous catalysis.

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Solvias also has longstanding experience in the field of heterogeneous catalysis and is able to develop highly chemoselective processes, including those for very complex and demanding molecules. One example is the successful application of the Solvias amine monomethylation technology for an improved synthesis of an API-intermediate, in which we developed a superior lab procedure and successfully demonstrated it on a kilogram scale.

Explore the wide application range of our modular ligand families on the

LIGANDS & CATALYSTS INFORMATION PLATFORM

http://ligands.solvias.com

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Custom synthesis and manufacturing

Whether your need is for gram-level synthesis of active pharmaceutical ingredients (APIs) early in the development cycle or 100-liter volumes for full-scale manufacturing, Solvias brings together the experience, resources and expertise required to meet the most demanding requirements. Newly designed processes can be readily transferred to our kilo lab in the form of a proof-of-concept study, or for scale-up and delivery of material to support preclinical and clinical studies. We also have long-term experience in transferring processes to custom manufacturing partners.

Solvias offers a state-of-the-art kilo lab equipped to handle a wide range of chemistry on scale under virtually unlimited reaction conditions. This includes cryogenic (–80 °C), high temperature (250 °C), hazardous and high-pressure chemistry (up to 300 bar). Our chemical development experts can rapidly develop scalable, robust and cost-effective chemical processes and optimize reaction conditions for complex, often chiral molecules. The launch of numerous production processes for Solvias customers is proof of our growing expertise in the area of process R&D.

A UNIQUE ASSET FOR OUR CUSTOMERS’ COMPLEX CHALLENGES

Solvias serves a diverse range of customers, from small startups and biotech companies up to large multinationals. In addition to a GMP kilo laboratory, we also offer synthesis according to ISO 9001 standards for non-pharma applications, TOX-batches or early steps of API synthesis. Working closely with colleagues in analytical services, the team of globally recognized experts in catalysis and solid state represent a unique asset when it comes to complex chemical and analytical development.

A powerful combination of proven expertise in custom synthesis and manufacturing along with catalysis and solid-state development allows Solvias to tailor solutions covering all aspects of modern early phase development. Our capabilities can take you from scalable syntheses to full GMP-compliant processes.

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Professional support can be offered in early preclinical to clinical development by delivering gram to kilogram quantities of APIs. This includes the development of robust, scalable syntheses and purification steps into fully GMP-compliant processes and transferring customer processes to our GMP kilo labs. In our ISO laboratories, we offer small-scale synthesis up to kilo scale of high-quality fine chemicals for research and development, including the synthesis of lead analogs, scaffolds, building blocks, metabolites, reference standard, impurities, degradation products and fine chemicals for technical applications, e.g. electronic materials.

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Process analytical technology

The continued success of our process analytical technology (PAT) and supporting services illustrates the value of high-technology products and a highly qualified team able to serve customers producing in harsh surroundings. Our products range from robust fiber optic probes to high-performance analyzers for toxic environments. Our PAT team provides efficient project support for customer-specific solutions for the life science, chemical and petrochemical industries. Our services include consulting, feasibility studies, installation and qualification of the equipment and the training of operators.

Solvias offers a wide variety of probes that operate in transmission, transflection, reflection and ATR equipment for online and inline analysis of liquids, gases and solids in laboratories and production plants. In addition to our wide range of standard fiber optic sapphire probes, we also work closely with customers to develop specialized immersion probes or flow cells, such as those designed for use in high-pressure and high-temperature applications or in highly corrosive environments.

Our extremely robust fiberoptic probes are designed to the highest fiber optic standards of performance in NIR and UV-VIS spectroscopy. Inline process photometers (multi-purpose analyzers) are connected with fiber optic probes designed for Ex-zones 0 and 1, and the photometer is located in a control room. A single spectrometer can be coupled with several fiber optic probes for transmission, reflection, transflection and ATR applications via standard SMA connectors or other common standards.

Solvias also produces high-performance analyzers for continuous monitoring of highly toxic or carcinogenic substances in the air or in the workplace. Based on GC technology, these monitors offer a high level of selectivity and sensitivity, as well as low detection limits <0.1 ppb, combined with high reliability.

Innovative solutions in process analytical technology enable our customers to monitor, understand and optimize chemical reactions and pharmaceutical processes under the most demanding conditions. We offer the competitive edge of experience and the ability to customize products and services to specific customer requirements.

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Solvias AG Römerpark 2, 4303 Kaiseraugst, Switzerland

+41 61 845 60 00 | www.solvias.com | info@solvias.com

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