Process Development

Process Development bridges the distance between the research bench and GMP manufacturing for clinical trials. It defines a set of specific objectives to ensure the production of a protein drug will be scalable, reproducible and cost-effective when manufactured under cGMP regulations.

Collectively, Paragon’s Upstream and Downstream scientists and engineers currently produce and purify hundreds of proteins per year.

Upstream Development

Media formulation / optimization for microbial, baculoviral and mammalian cell culture projects

Non-animal origin media solutions

Development of fed-batch strategies for higher cell densities and product titers
Optimization of expression kinetics
Optimization of product recovery

Centrifugation (including PK)

Tangential flow filtration (UF/MF)
Depth filtration
Inclusion body: solubilization, recovery and refolding optimization

Downstream Development

Column chromatography

Ion exchange
Hydrophobic Interaction (HIC)
Affinity
Size exclusion
Expanded bed absorption
Hydroxyapatite

Step or Linear gradient elution
TFF for concentration or buffer exchange
Impurity removal (viral, endotoxin, residual DNA, HCP)
Preliminary stability studies
Large-scale HPLC

Analytical Development

With over twenty-five years’ experience in Analytical Development, Paragon’s Scientists excel in the development and implementation of in process and release assays for biological therapeutic manufacture. In addition, Paragon strategically utilizes key, audited subcontractors for select specialized analysis (e.g. cell bank characterization, viral clearance studies) when such services are more cost-effectively outsourced. This combination puts us in the unique position to not only have the skill and services necessary for assay development and support, but also the means to provide these assays in the most cost and time efficient manner.

Capabilities available in-house at Paragon include:

Gel electrophoresis (Native, SDS-PAGE, agarose)
HPLC assays (SEC/RP/IEX)
Immunoassays (Western Blot, ELISA, Flowcytometry (Guava))
Mass Spectrometry
RT-PCR
Odyssey™ IR immunoassays
Dynamic Light Scattering
Capillary Electrophoresis (SDS-PAGE, IEF)
CRL EndoSafe-PTS endotoxin assay
Spectrophotometric assays
Bioassays
Enzyme assays
Gas Chromatography
Transmission Electron Microscopy
Immunoassays
Functional Assays
Characterization and Release Assays

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