Process development

Bioconjugation typically changes the properties of the parent biomolecule significantly and thus requires the tailored development of a robust, scalable and cost efficient manufacturing process for each bioconjugate. Biosynth GmbH has extensive experience in this area and has successfully optimized, scaled and transferred manufacturing processes into a large scale GMP environments. We offer services in optimizing individual process steps as well as the development and scaling of the full manufacturing process.

Scope of work:

• Optimization of individual process steps (such as reaction conditions)
• Development of scalable purification methods
• Robustness testing of critical process steps
• Development and qualification of suitable analytical methods for IPC and release testing
• Consistency runs and technical batches
• Generation of reference standards

Process development services typically take 4 to 8 months, depending on the scope of the project.

We are able to manufacture the bioconjugate for first-in-human studies, but we are also willing to transfer the final process to another CMO of the customer’s choice.