If you are looking production capacity for your recombinant protein, 53Biologics is your best option. But your manufacturing needs are not one size fits all, that is why 53Biologics offers a manufacturing structure fully customizable and adaptable to fulfill its clients need in time, cost and manner.

Supporting you in the initial preselection, 53Biologics could offer lean benchmarking projects to compare different hosts and options, working with IPfree systems but also able to suggest you the most breakthrough and validated technologies from its collaborators.

  • In time because 53Biologics is ready to start this kind of project on a very short notice, usually 2-3 weeks after the signature of the contract and the order reception.

  • About budget, the lean and flexible operations structure of 53Biologics has demonstrated to be cost competitive against competitors.

  • And in manner means fulfilling the required quality standards. 53Biologics operates its first-class facilities under certified ISO 9001:2015 but also complying with:

      • ISO13485:2016 for the research use materials and ancillary reagents.
      • cGMP the current Good Manufacturing Practice (cGMP) and in continuous improvement.

Almost all the process configuration (USP & DSP) could be reproduced at 53Biologics’ state-of-the-art facilities in two quality grades.

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