53Biologics

53Biologics has a vast experience executing and leading projects related to biological drugs preclinical development and recombinant proteins production. To this aim, the company offers the following services: 

Cell line transformation, banking and characterization (cGMP if required): 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 bacteria (E. coli, Bacillus, etc.), yeast (Pichia, Saccharomyces) or fungi (Trichoderma, Aspergillus and the revolutionary C1; www.dyadic.com), etc.), mammalian expression systems such as CHO, HEK 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 Cell Bank generation and characterization, information required for the Investigational Medicinal Product Dossier (IMPD).

Process development (USP & DSP): In 53Biologics, 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. 

Analytics: 53Biologics can implement, developt and qualify the analytical methods needed for the characterization of the protein of interest. The company has a broad range of techniques available for the physic-chemical characterization of recombinant proteins and in-process controls set up, and a strong network of collaborations with highly specialized analytic laboratories if more specific tests are needed for a specific product. 

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 production of batches at different fermentation volumes, with a high ability to adapt to the method transferred by the client and always meeting the agreed deadlines.