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.

Column mounted at the column holder
Column mounted at the column holder

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.

Contact partner

Dr. Julia Wittmann

Dr. Julia Wittmann
Head of Bioconjugation

+49 30  9489 2350

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+49 (0) 30 94892350

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