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 celares GmbH was inspected by LaGeSo and has been GMP-certified according to EU guidelines since end of 2019.
Capabilities and equipment
The manufacturing facility at celares GmbH is equipped up to the latest technological standards, enabling us to offer multistep syntheses from g to kg scale.
Processes and techniques
A selection of available processes and techniques to manufacture bioconjugates as well as small-molecules and artificial polymers established by celares GmbH.
Tailored manufacturing services for high quality-requirement / high purity compounds, such as pharmaceuticals, excipients or reagents for diagnostics.