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.

Stein large-scale commercial manufacturing expansion

 

At our Swiss Manufacturing Site in Stein, near the Basel Pharma Hub, we are completing a large-scale commercial biologics filling expansion. The facility will be operational from first-half of 2027.

The state-of-the-art facility spans approximately 20,000 m2 and incorporates latest manufacturing technologies such as advanced automation and precision filling for vial, PFS and cartridge filling as well as vial lyophilization.

We have invested around CHF 500 million in this large-scale manufacturing facility to provide you with capacity and technologies across scales integrated with Lonza Biologics drug substance network and tailored to your needs.

Schedule a free consultation to secure your capacity!

Dolphin expansion rendering
Regulatory expertise
Pathway to success in Regulatory filings
Biologics
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