Paragon Bioservices offers GMP Manufacturing Services for a variety of drug substances and drug products such as therapeutic proteins, antibody fragments, polysaccharides, and vaccines utilizing a variety of microbial platforms that incorporate various BSL-1/2 organisms. Our validated manufacturing scale goes up to 240L Wv with two microbial suites each containing a traditional, fixed/stirred tank fermenter built by Eppendorf (NBS).
Paragon’s microbial facility is also equipped with a 800L refolding tank to facilitate manufacturing processes that require production using inclusion bodies. Each suite also contains a centrifuge and microfluidizer along with a variety of TFF equipment to recover and isolate your product under ISO 8 conditions for further purification. Paragon’s purification abilities utilize standard, dedicated BPG columns ranging for 10–45cm, running with GE AKTA Process skids in the segregated ISO 7 room of the manufacturing suite. Tremendous flexibility for operating the suites allows Paragon to bring in additional equipment from our clients (or other sources) if the need arises.
At the end of the process, your drug substance can be shipped directly to the client or Paragon offers full capabilities to produce your final drug product in an ISO 5 fill suite using a fully automated filler, from which finished vials can be stored then shipped as directed.