CLIENTS

OUR experience comes from supporting the cGMP manufacturing of bulk drug substances (BDS) for many of our clients:

Biologics: GENENTECH – Monoclonal Antibodies (mAb), BIOTEST – Blood Factors, GENZYME- Vaccines, SANOFI – Vaccines, DSM – Contract Manufacturing

Pharmaceuticals:  BIONICHE- Small Molecules, OMEGA LABS, CHURCH & DWIGHT,  PAR Pharmaceuticals – Solid Oral Dose/liquids and Ointment

Our subject matter experts (SMEs) provide leadership and guidance to clients as their processes to overcome the technicalities and challenges with a know how to comply with the regulatory environment. We are a team of SME in upstream and downstream processes as well as fill-finish.  We worked on formulations for sterile processing as well as analytical methods for characterization and product release.    When added value we suggest the disposable component technologies, testing to ensure they meet GMP requirements during process implementation. These services include installation, and commissioning of cGMP facilities and process equipment used in the development and manufacture of biopharmaceutical drugs. We partner with engineering companies to support every phase of the “GEP Lifecycle” from planning for new products to process optimization to retirement of equipment.