Process Development

Production of biopharmaceutical materials requires the utilization of a living system for their manufacture. Paragon has been developing scalable upstream and downstream manufacturing processes for our clients since 1990. Paragon’s expertise spans a multitude of production processes including expression in bacterial and yeast cells, stable and transient expression in mammalian cells and virally-transduced production in mammalian and insect cells.

Upstream Development

All industry standard production platforms (Mammalian, Insect, Virus, Microbial)

Cell line construction and development

Media and feed optimization for batch and fed-batch productions (non-animal-origin components)

Suspension and adherent cell lines using single-use technologies

High cell density and product titer cultures

Transient chemical transfection at large-scale

Harvest, lysis, and clarification

Development strategy of scale-up using scale-down models (Micro-24 MicroReactor System, 2-10L Stir-tank Bioreactors, DASGIP® Parallel Bioreactor Systems, iCELLis® Nano

Scale-up verification at Pilot Scale (BIOSTAT® STR 50L & 200L bioreactors, iCELLis® 500 fixed-bed bioreactors, B. Braun 150L fermentor, New Brunswick 300L fermentor)

Downstream Development

Protein Purification (vaccine antigens, therapeutic proteins, mAbs)

Recombinant/Wild-Type Viruses (adenovirus, AAV, HSV, RSV, CMV, Zika)

Polysaccharide conjugates Enveloped and non-enveloped Virus-like particles (HPV, CMV, JCV, BKV, VEE, HIV, Ebola)

Column and membrane chromatography (affinity, ion exchange, hydrophobic interaction, mixed-mode)

Bioprocess filtration (tangential flow, hollow fiber, depth filtration)

Centrifugation (low speed (Unifuge) and ultracentrifugation)

Development of closed-system processes for therapeutic product types that are not amenable to sterile filtration including performance of process simulation studies

Wide-array of analytical capabilities to assess product quality and guide downstream development effort (HPLC/UPLC, qPCR and ddPCR, capillary electrophoresis (SDS-PAGE, IEF), immunoassays, dynamic light scattering, cell-based bioassays, and electron microscopy)