Paragon Bioservices offers GMP Manufacturing Services for a variety of drug substances and drug products such as monoclonal antibodies, therapeutic proteins, and virus-like particles utilizing a variety of cell culture platforms. Specifically, Paragon has prior experience with stable mammalian cell lines, transient mammalian production, baculovirus expression vector system, and stable insect cell lines. In our cell culture facility, manufacturing scale goes up to 500L Wv with two upstream production suites each containing single-use bioreactors (Sartorius (2x200L) and Xcellerex (500L)).
Each suite also contains incubators, centrifuges, and Wave bioreactors for scale-up 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 downstream rooms. 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.