Biotechnology is gaining importance in the life science industry today. Its products are used as raw materials or excipients in numerous industries. In fact, biotechnology processes are used to manufacture pharmaceutical products in the field of novel therapies. GMP compliance is an important issue here as well.
gempex has customers in all biotechnology branches. The primary focus is on what is called white and red biotechnology. Applications range from simple fermentation to complex production processes with recombinant proteins or human tissue. From antibody to cytoplasm, starting with eukaryotes and prokaryotes.
gempex accompanies the entire process from the production of active substances to the finished pharmaceutical product or clinical test preparation. This includes both upstream and downstream processes as well as formulation and packaging. Projects range from simple qualification to full-service assignments for obtaining manufacturing approval according to Section 13 of the German Medicines Act (AMG). This requires in-depth technical expertise and, in particular, detailed expert knowledge, for instance in the field of sterile technology. The objective is: meeting regulatory requirements consistently and reliably while making processes secure and stable using quality assurance.
gempex is a proven expert for all GMP matters in biotechnology and apparatus construction by medical technology suppliers.
Selected Service Examples*
- New Production Area for Pharmaceutical Active Ingredients Manufactured Using Biotechnology
Prospective qualification, validation, comprehensive GMP-QM support: risk analyses, documentation, re-qualification, validation, training, internal audits
- New Construction of Research Facilities and for the Manufacturing of Clinical Test Preparations
Validation concept development and implementation, coordination of all qualification activities, QA system implementation, GMP support: documentation, qualification (DQ, IQ, OQ, PQ), training, co-auditing and more
- Production of Biotechnology Active Ingredients Precursors
Qualification of all production and media systems as well as laboratory equipment
- Setup of a Facility for Producing Cell Therapeutics
Full service for obtaining manufacturing approval according to Section 13 of the German Medicines Act (AMG), development and implementation of a QM system including training, implementation of manufacturing documentation, qualification, validation, inspection support
* We will gladly provide you with specific references on request.