Capabilities

The manufacturing facility at Biosynth GmbH is equipped up to the latest technological standards, enabling us to offer multistep syntheses from g to kg scale, for non-GMP as well as for GMP campaigns. The manufacturing takes place in a cleanroom class D.

Our manufacturing facility is equipped with:

• 10 L (Büchi) and 60 L (QVF) double jacket glass reactors
• 20 L Rotary evaporator (Heidolph)
• Gas washer (QCF)
• 50 L Stirred vessel (QVF)
• Suction filter (QVF)
• Tangential flow filtration systems (Sartorius)
• Centrifuge (Eppendorf)

A second manufacturing suite is planned and will be in operation beginning 2025. This manufacturing suite will be dedicated to the production of bioconjugates and conjugate vaccines for clinical trials and market supply.

For the release testing of drug substances and drug products, we run a QC lab that is equipped with the following qualified state-of-the-art analytical devices:

• HPLC system (Waters Alliance with PDA & ELS detection)
• UPLC system (Waters Acquity with TUV & ELS detection)
• SEC-MALLS system (Agilent 1260, PSS with UV, RI & MALLS detection)
• UV/VIS photometer (biochrom Libra S70)
• Multiwell-plate-reader (Tecan Infinite M Nano)

If the equipment that needed to synthesize or manufacture your compound is not listed above, please contact us to discuss your specific requirements and we will coordinate on how we can support you.