This flexibility has helped 53Biologics to develop a huge variety of processes adapting and developing a broad catalog of recombinant proteins (monoclonal, fusion, chimeric and fragment antibodies, biosimilars, enzymes, anticoagulants, vaccines, etc.) in a wide range of microbial expression systems such as bacteria (E. coli, Bacillus, etc.), yeast (Pichia, Saccharomyces) or fungi (Trichoderma, Aspergillus and the revolutionary Dyadic’s C1, etc.), mammalian expression systems such as CHO, HEK and insect cells like S2. Depending on the required final specifications, 53Biologics has implemented dozens of processes from straightforward recovery methods till complex ones including refolding from inclusion bodies with post-chemical modification processes.
During the Downstream process development and optimization, 53Biologics would be also your analytical partner for the establishment and validation of the most suitable In-Process Control (IPC) methodologies. In-process control (IPC) methods are an essential part of the quality control (QC) strategy during the manufacturing process.