If you are looking production capacity of your protein of interest no matter if it would be used for your preclinical batches or as ancillary reagents, 53Biologics is your best option.

In the case of regular production of ancillary reagents or enzymes used in the manufacturing of other therapeutic products, 53Biologics is an ideal partner covering a customizable quality standard from ISO9001, to ISO13485 to cGMP.

In the case of clinical batches, 53Biologics makes possible the assessment of the scalability of your protein and speeding up the subsequent manufacturing. This has motivated that the company nowadays operates under cGMP environment covering from the cell banking related activities, analytical and process development and to the regular batches production (one-stop-shop).

As 53Biologics gathers years of experience in development, scale-up, validation and transfer of bioprocesses, the company can give to their clients a better understanding of the road map ahead up to product manufacturing. ​ Clients can take the benefits of the 53Biologics ready-to-use development and production facility, its efficient operation structure and its experience compiling the suitable information required for the IMPD.

The cGMP manufacturing suite includes ISO Class 7 and 8 clean rooms and analytical and functional support laboratories to complete the quality product testing. The suite includes a maximum fermentation capacity of 100L mainly designed for microbial fermentation.

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