Monoclonal antibody is produced in vitro using roller bottles.
Production in roller bottles allows precise definition of the proteins
and other molecules present in the supernatant. Media formulations
containing low bovine IgG fetal bovine sera, serum-free media, or animal
protein-free media can be used when the absence of proteins is
necessary. Monoclonal antibody produced in roller bottles is typically
purified before shipment. Monoclonal antibody can be produced in roller
bottles in milligram or gram quantities.
In Vitro Production
-
Roller Bottle Production
- Lot Size 5 – 100L
- Use SDIX standard hybridoma media formulation or client custom media formulation
- All incoming cells lines require pre-production verification
- Includes
- Viability check of cell line
- Limited Dilution Cloning (Verify Monoclonality of cell line)
- Mycoplasma testing
-
Isotype testing
- Final IgG concentration is determined by Radial Immunodiffusion assay
- All incoming cells lines require pre-production verification
- Timing is 6-8 weeks
In Vitro Purification Services
Platinum Package
- Perform Protein A or Protein G Purification
- Full lot records documentation
-
Custom Final Buffer Formulation
- Custom Final Concentration
- Custom Packaging (up to 25 vials)
- Final QC
- Isotype
- HPLC Purity
- Immunoelectrofocusing gel
- Certificate of Analysis
- Timing – 3 weeks
Gold Package
- Documentation in form of data sheet
- Perform Protein A of Protein G Purification
- Concentration >1mg/mL
- Buffer Formulation is PBS or PBSA
- Bulk Packaging
- Final QC
-
Certificate of Analysis
- Timing – 3 weeks