Transient Mammalian GMP Manufacturing

Through our services, Paragon enables the translation of our client’s technology into a product that is suitable for testing in a Phase I or II clinical setting.  Our integrated capabilities provide agility and flexibility so that we can quickly engage and meet aggressive timelines.  The efficient integration of new technologies and cutting-edge techniques allows us to help our clients with unique expertise that distinguish Paragon as a leader in contract development manufacturing.

One such unique capability is the manufacturing of clinical material by means of transient transfection of mammalian cells under cGMP conditions.  The production of reagent-grade material by transient transfection has been a common practice for many years.  Paragon Bioservices has been offering this service for more than a dozen years and has produced hundreds of proteins this way.  However, for clinical use, the standard method for producing therapeutic proteins and recombinant antibodies in mammalian cells has been to create a clonal, stable cell line.  This practice adds considerable time and cost to manufacturing program although recent advancements in stable cell line generation have significantly improved timelines from what they were.  Nevertheless, transient production of clinical material can be done considerably faster and cheaper.  In addition, this method offers some safety advantages in that the transfected plasmids exist within the cell as epichromasomal vectors and do not integrate into the chromosome and cause insertional mutations.

The utilization of transient manufacturing process under GMP conditions is not a completely novel concept.  For years, companies and academic institutes have been manufacturing recombinant viruses such as AAV by chemical transfection of HEK293 cells.  More recently, the industry has begun to accept the utility of this manufacturing method for biologics that are damaging or toxic to the host cell.  Virus-like particles (VLPs), especially those that are enveloped, are a prime example of a biological product that benefits from a transient manufacturing process.  Paragon Bioservices has positioned itself as a leader in this field with several high-profile manufacturing programs that have included process development and GMP manufacturing using a transient process.  In all, Paragon has performed nearly three dozen such transient productions at scales from 50L to 200L.

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