GMP-production of Drug Substance and Drug Product for clinical trials and launch supply has been our daily business for many years.
We established the Heidelberg facility 2008 for the supply of our own studies. Now we utilize less than 30% of our overall capacities for ourselves and more than 70% are dedicated for our client´s projects. Here we offer the full spectrum under GMP from Cell Banking over USP/DSP-production to Drug Product manufacturing meaning aseptic Fill & Finish.
Cell lines developed under our supervision fulfill all pre-requisites for the development of an optimal production process. Cell banking projects are performed in compliance with relevant regulatory requirements.
Our services in the area of cell banking include:
- Production and long term storage of Master and Working Cell Banks (MCB/WCB)
- Characterization of Master and Working Cell Banks
Upstream Processing / Cell Culture
Upstream processing includes all steps from cell banking to cultivation of the cells in bioreactors until final harvest. We provide GMP compliant cell culture production for clinical and for small scale drug substance manufacturing. Cultivation methods include fed-batch and perfusion mode. Manufacturing can be performed in stainless steel and single-use bioreactors.
Our facility includes five fermentation suites equipped with bioreactors at following scales:
- Stainless steel bioreactors: 10L, 50L, 100L and 250 L
- Single-use bioreactors: 10L , 20L, 200L and 1,000L
Downstream Processing / Protein Purification
The purification of proteins from cell culture supernatant is a crucial step in the production of active ingredients. We provide GMP compliant purification processes to ensure that the final product meets all regulatory requirements.
Our services in the downstream processing area include:
- Process scale-up
- Engineering runs and GMP production
- Process validation according to GMP guidelines
- Viral safety validation, including scale down models
Fill and Finish
Through its highly flexible setup, our fill and finish facility can easily be adapted to meet customer dosage, formulation and filling needs. It is designed for clinical supply.
Our services include the aseptic filling of liquid solutions in glass vials at batch sizes up to 1,000 vials. Furthermore, labelling, packaging and shipment can be performed upon request.
We operate in full compliance with FDA and EMA standards. Clinical samples produced and characterized at our site can be released by our qualified person.
Regulatory support is provided for preparation of the IMPD document (quality part of the CTA documentation).
A dedicated project leader will manage the project throughout its life cycle within Glycotope Biotechnology. The project leader manages all activities and serves as the central contact person for all project related matters for the customer.