Each recombinant protein has quality attributes that make them different. Each recovery and purification process should be adapted to the protein and the final desired specifications.

At 53Biologics we are strongly convinced that assuring a robust, reproducible, commercially viable manufacturing process facilitates the success through the clinical development and for the commercialization.

Our facilities are specifically designed to identify and to address your production challenges accelerating the timelines for delivery. In our labs and pilot plant, different operations units like clarification by centrifugation, cell rupturing, refolding, diafiltrations, postproduction treatments, microfiltration, ultrafiltration, chromatography techniques (affinity ie. IMAC, size exclusion, ion exchanges, amongst others), etc. could be tested and implemented at 53Biologics. And we won’t stop there, just let us know which are your requirements.

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.

For 53Biologics a waiting list is one of the most affecting points to these kinds of developments. For this reason, our downstream development projects typically start in a very short notice, typically in less than 2-3 weeks from an agreed scope of works (just the time required to acquire the needed compounds and only if they are not in our stock).

For preclinical drug development, 53Biologics compiles all the information required to fulfil the CMC section of the IMPD, expediting transfer to manufacturing.