cGMP Manufacturing

Versatility, superior quality, and unparalleled partnership are the defining features of our cGMP manufacturing services.  We offer such services for a variety of drug substances such as recombinant viral vectors (AAV, Adenovirus, HSV), therapeutic proteins, vaccines (live attenuated pathogens), virus-like particles, monoclonal antibodies, antibody fragments, and polysaccharides.  Paragon has prior experience with a multitude of production processes including stable mammalian cell lines (CHO, CAP), transient mammalian production (HEK293), baculovirus expression vector system, as well as various microbes and live viruses. Our experienced production teams oversee three separate state-of-the-art cGMP facilities, which are dedicated to microbial, cell culture (mammalian & insect), and virus manufacturing.  Each facility has multiple upstream and downstream manufacturing suites to accommodate parallel manufacturing campaigns.  The Paragon Quality Control and Quality Assurance Group (QA/QC) oversees the entire production process from the validation of equipment to the approval of the documents required (SOPs, batch records, validation reports, etc.) to release the cGMP product.  All products are segregated and produced on a campaign basis and validated change-over and cleaning procedures are deployed between each project. Paragon systems and procedures are developed and maintained to ensure cGMP compliance to applicable FDA and EMA regulatory requirements and standards.  Backed by years of success and an industry-leading team of scientists, Paragon is the logical choice for your complex biopharmaceutical manufacturing.