Our decision to offer manufacturing capabilities dates back to 2009, and our first facility for manufacturing became operative in 2010. Our manufacturing facility is classified as cleanroom class D (ISO 8) and is equipped up to the latest technological standards, with double jacket glass reactors and Sartoflow diafiltration systems just to mention two. Manufacturing capabilities for batch sizes for small molecules and polymers range from 100 g to kg. Bioconjugates can be manufactured in gram to 100 g batches.
We have since extended our manufacturing portfolio with a QC lab for GMP compliant release testing of drug substances (DS) and drug products (DP) and recently by a production unit for the automated manufacture of micro volume plugs for diagnostic applications.
The QC lab of the Biosynth GmbH was inspected by LaGeSo and has been GMP-certified according to EU guidelines since end of 2019. A successful re-inspection has been followed in 02-2023.