A Targeted Approach
53Biologics is a CDMO with extensive experience in decoding biologics overexpression providing services of cell line transformation, banking and characterization (cGMP if requiered), analytical development, process development (USP & DSP) and batches.
Protein Expression – Escherichia coli, Pichia pastoris, Fungal platforms, Mammalian cell lines
GMP Cell Banking
Process Development – Upstream Development, Downstream Development, Analytics
Contract Manufacturing
Protein Expression
53Biologics has proven experience producing a broad catalog of recombinant proteins, in a wide range of microbial expression systems such as bacteria, yeast or fungi, 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.
Process Development
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.
53Biologics can implement, developt and qualify the analytical methods needed for the characterization of the protein of interest.
For preclinical drug development, 53Biologics compiles all the information required to fulfil the CMC section of the IMPD, expediting transfer to manufacturing.
GMP Cell Banking
53Biologics performs cell transformation, banking, and characterization to develop your research or master cell bank but also following the current Good Manufacturing Practices certified by the European Medicines Agency (EMA) and Food and Drug Administration (FDA). GMP operations are conducted in ISO 7 and ISO 8 classified rooms and suites.
Cell line characterization is crucial to the control of the biologics manufacturing. The identity, purity and stability confirmation are key for the subsequent use. Each quality test should be adapted to the host and product so the characterization strategy must be customized for each project.
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.
>15 years executing and leading projects of a broad catalogue of recombinant proteins in an extensive range of hosts and scales.
More than 98% of proteins in our hands have improved their production and/or recovery yields.
An average of 3-4 contacts per week (mails, phone calls, meetings, follow up,…) with our customers during the project execution
