Services and GMP-conform routine production
In close consultation with our customers, we offer both, clear-cut contract process development or pure contract manufacturing as well as the entire cooperative project development process up to validated, GMP-conform routine production.
We have the knowledge and flexibility to follow changing market requirements. BBT Biotech GmbH recognizes the importance of meeting unique product specifications and listens attentively to each customer’s wishes.
Please ask us to provide solutions for your unique contract manufacturing or new product development needs. If you intend to register pharmaceuticals based on BBT active ingredients, we are of course able to provide you with the corresponding Drug Master Files (DMFs).
Please let us know about your needs!
Laboratory services (lab for commissioned analytics)
With our fully equipped laboratories and our highly qualified and motivated personnel in our quality control department, we are able to perform in-house testing and analysis in the fields of microbiology, biochemistry and chemistry for our in process controls (IPCs), for certificates of analyses (CoAs) and for ongoing stability testing. Compliance with current GMP standards is our top priority. Our work is carried out in compliance with regulatory requirements (GMP; Good Manufacturing Practice), so we strive to meet the highest quality and technical standards. We do not only perform tests according to the respective pharmacopoeias but continuously expand our repertoire of self-developed, fully validated methods for special applications.
We offer our customers various services as a complete package or individual modules: Contract manufacturing, the performance of contract analysis as your contract laboratory and additionally the services of our regulatory affairs department in the preparation of single documents or complete parts of the registration documents in accordance with the latest laws and regulations.
GMP Production | Quality Assurance | Bulk Manufacture
Certificates of Analysis (CoAs), Certificate of Compliance (CoC) or the Site-Master File (SMF) are supplied accordingly. BBT Biotech GmbH also welcomes audits and inspections at customer’s request.
Key competences:
- Regulatory support in the course of product development
- Validation: Equipment, QC assays, production processes (SOPs) and products
- Contacts with authorities
- Project coordination
- Management of external documents and monitoring of procedures
- Implementation of QA-audits
Our APIs (Active Pharmaceutical Ingredients) are manufactured in state-of-the-art facilities. The production process is GMP-certified and comprises the two areas of fermentation and downstream processing.
Fermentation and downstream processing take place in separate facilities equipped with modern instruments for protein purification. Our experienced team has strong knowledge in a whole range of production and downstream methods, validation, and protein analytics. The range of services which we offer can be tailored to the individual needs of each customer.
Key competences:
- GMP production for early phase clinical trials with fermenters on a scale of 30 - 750 liter
- Commercial GMP production on a scale of up to 18,000 liter
- Process validation according to GMP
- Process QC according to GMP
- Product releases
Further services and certificates
Documentation:
A Quality Management System in accordance with EU GMP requirements for pharmaceuticals is well established and maintained. A GMP certificate as well as a manufacturing license is issued by the pharmaceutical authority.
Current Common Technical Documents are also available as eCTD for all pharmaceutical products. The Regulatory Affairs department is highly experienced in applications of biotechnological products.