Bioprocessing & GMP Manufacturing

Cutting Edge Manufacturing

ServareGMP’s Founders are the Founders of PacificGMP, the first cGMP development and manufacturing organization (CDMO) to fully realize the revolution in single use bioprocessing in its operation. Servare’s Principals developed and manufactured over 65 separate complex biologics for use in both human clinical trials and commercial patients.

ServareGMP will perform internal development and manufacturing for each mAb at a state-of-the-art facility in Carlsbad, CA. Modeled on the same complex bioprocessing capabilities and its single use platforms successfully utilized at PacificGMP’s GMP Facility (and associated process development capabilities), Servare’s new Facility will accommodate the development and manufacture of numerous drug candidates in the its pipeline.

Integrating internal capability of development and GMP manufacturing will greatly speed up the product pipeline, substantially reducing time to market, but will also allow Servare to have complete control over its development timeline and costs

Biologic Drug Products Development & Manufacturing

•   Recombinant proteins
•   Monoclonal antibodies
	-  Fusion proteins
	-  Conjugated antibodies
	-  Bi-specific antibodies
	-  Recombinant enzymes
	-  Virus-like particles
•   Mammalian master, working & development cell banks, bacterial master cell banks
•   Insect cell & Baculovirus master & working cell and viral banks
•   Viral vectors for gene therapy programs (under proper facility segregation)
•   Phase I, II, III & Commercial GMP products
•   Batch, Fed Batch, Continuous Perfusion, Concentrated Fed Batch
•   2000L Fed Batch Scal x 2 to 4 platforms
•   15,000L Perfusion scale on 1000L and 500L platforms
•   CHO, Hybridoma, HEK-203, A-549, NS0, HT1080, Insect cell lines & Baculovirus expression