Biotechnology
Biotechnology is becoming increasingly important within the life science industry. Its products are used as basic materials or starting materials in numerous industries. In the field of advanced therapies, the results of biotechnological processes even constitute the drug. GMP compliance is also an important issue here.
Customers of Medcycle-Consulting GmbH come from all branches of biotechnology. The focus is mainly on the so-called white and red biotechnology. From simple fermentation to complex manufacturing processes with recombinant proteins or human tissue.
Medcycle accompanies the entire process, from the production of active ingredients to the finished drug or clinical investigational product. This includes upstream and downstream as well as formulation and packaging. Projects from simple qualifications to full-service tasks to obtain the manufacturer's license according to § 13 AMG. This requires a lot of technical expertise and, above all, in-depth expert knowledge, for example in sterile technology. It is always important to meet the regulatory requirements reliably and in a tailor-made manner and at the same time to design the processes securely and stably with the tools of quality assurance.
Medcycle is an expert for all questions relating to GMP in biotechnology and in the medical technology supplying apparatus construction.
Examples of services
- New manufacturing area for biotechnologically manufactured API
Prospective qualification, validation, comprehensive GMP-QM support: risk analysis, documentation, re-qualification, validation, training, internal audits
- New building for the manufacture of clinical investigational medicinal products and research facility
development and implementation of the validation concept, coordination of all qualification activities, implementation of the QA system, GMP support: documentation, qualification (DQ, IQ, OQ, PQ), training, co-auditing, etc.
- Production of biotechnological active ingredient precursors
Qualification of all production and media systems as well as laboratory equipment
- Construction of a plant for the production of cell therapeutics
Full service to obtain a manufacturing license according to § 13 AMG Construction and implementation and training of a QM system, implementation of the manufacturing documentation, qualification, validation, inspection support.