Biotechpharma is a European industry leading full-service cGMP development and contract manufacturer (CDMO) based in Vilnius, Lithuania. We have certified cGMP facilities with upstream and downstream process capabilities matched to our single use mammalian manufacturing assets (up to 2000L) and stainless steel manufacturing assets and we can develop your product through to early clinical phase and all the way to commercial manufacture.
We are very experienced in the development of many types of recombinant proteins including monoclonal antibodies, enzymes, cytokines and fusion proteins using a variety of host cell systems including E.coli and CHO. We offer full analytical capabilities, cell bank storage facilities, formulation and Fill/Finish, as well stability programs, process characterisation and validation for late phase clinical and commercial programs.
Areas of expertise include:
• Cell line/strain development, GMP-cell banking and storage of MCB and WCB
• Process development
• Efficient protein refolding and downstream process development
• Drug substance and drug product cGMP manufacturing
• Technology transfer
• cGMP compliant analytical services
• Process characterisation and validation
• Protein formulation development
• Stability studies
• Project management
Biotechpharma ensures a complete execution of biopharmaceutical projects by combining its state-of-the-art R&D and GMP manufacturing infrastructure with a highly experienced staff. Services include expression system design, proprietary Drug Substance (DS) process development, Drug product (DP) formulation development, analytical methods development and validation, technology scale-up, process validation, DS and DP cGMP manufacturing for pre-clinical, phase I-III clinical trials and commercial production. We also support the clinical trial programs of our clients by executing stability studies and compiling regulatory documentation (CMC-part).