Research - Boecillo, Castilla y León, Spain
53Biologics is a contract development and manufacturing organization with extensive experience in cell line development, bioprocess development and scale-up, and recombinant protein batches production. Our mission is to provide services to different companies, from start-ups to large companies, as well as to other CDMOs, to help their products to reach the market. 53Biologics works in a quick, proactive and efficient way, always ensuring very high-quality standards. 1) Cell line development: 53Biologics has proven experience producing 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 yeast (Pichia, Saccharomyces), fungi (Trichoderma, Aspergillus and the revolutionary C1; www.dyadic.com) or bacteria (E. coli, Bacillus, etc.), mammalian expression systems such as CHO and insect cells like S2. During the last years, the company has developed an efficient molecular biology toolkit to improve protein expression and stability, that is now available for its clients. 53Biologics has experience in the Research Cell Bank establishment and characterization, information required for the Investigational Medicinal Product Dossier (IMPD).2) Process development: In 53 Biologics, we are experts in the optimization of the production process, product recovery and purification. The company goal is to get all bioprocess stages established, optimized, and characterized, ready to be transferred for manufacturing. For preclinical drug development, 53Biologics compiles all the information required to fulfil the CMC section of the IMPD, expediting transfer to manufacturing. 3) Contract productions: 53Biologics offers to its clients a ready-to-use production facility and a very experienced team on recombinant protein batches production. The company offers very a high production flexibility, making possible the productio
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