Biotechpharma is a European industry leading full-service cGMP development and contract manufacturer (CDMO) based in Vilnius, Lithuania. We have fully licensed cGMP facilities with upstream and downstream process capabilities matched to our core 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 programmes, Process Characterisation and Validation for late phase clinical and Commercial programmes.
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 • stable protein formulation development • stability studies • project management