Antibody Bulk Production

Phase	Process
I : Receipt of client cell line	We will receive your cell line as a frozen ampoule of growing culture Initial growth in serum supplemented medium followed by mycoplasma analysis using PCR
II : Pilot 1 L production	Adaptation of cell line onto protein-free medium Scale-up in roller bottle culture, typical yield of 20-40mg of purified antibody
III : Downstream processing	Harvesting of cell culture supernatant Concentration by tangential cross flow filtration Protein A/G purification Final buffer formulation
IV : QC assessment of antibody purity	Analysis of purity by SDS-PAGE, WB, ELISA and aggregation assessment by SEC
V : Antibody scale-up	Milligramme to Gramme quantities Scale up performed using bioreactor system Purification using Protein A/G affinity chromatography

Final Deliverables

• Purified monoclonal antibody, protein, or concentrated supernatant to requested scale (up to 250L)
• Working Cell Bank for Scale-up cell line
• Project report with ELISA, SDS-PAGE, Western Blot, and SEC performance data