Biologics Drug Product Manufacture

20+ Years of GMP Manufacturing

We have extensive expertise in designing manufacturing processes, evaluating and characterizing various unit operations. We support choice of the best materials and parameters to ensure successful drug product manufacturing.

Clinical and Commercial Supply

We provide increasing flexibility and capacity availability through our network of DP filling sites.

Vial and Syringe Filling

We offer aseptic filling of liquid vials and syringe as well as lyophilization of parenteral biologics.

Full cycle drug product manufacturing support

Primary packaging development and qualification
Get support in the selection and qualification of the right primary packaging that is compatible with the drug product formulation.

Development, Tox batch and Reference Standard manufacturing
Accelerate the timeline for IND submission with toxicological studies. Access our state-of-the-art pilot-scale aseptic manufacturing capabilities and our ability to supply high-potent drug products (such as Antibody-drug conjugates) for toxicological study or stability and regulatory purposes.

Technology transfer
Employ a team to design the suitable clinical/commercial manufacturing process for your molecule and generate the required source documents for manufacturing.

GMP manufacturing (biologics drug product) as liquid or lyophilisate
Our team offer you clinical and commercial DP GMP manufacturing, risk assessment and development.

Investigation support
Our experts can support assessments, RCIs and generate data to close out the investigation.

Our locations

Locations where this service is provided

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Basel Stücki, Switzerland

Stein, Switzerland

Visp, Switzerland

Guangzhou, China

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Regulatory expertise

Pathway to success in Regulatory filings

Extensive Regulatory Expertise

We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.

Dedicated Regulatory Affairs Contact

We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.

Keep Pace with Regulatory Thinking

Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.

Biologics

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