Mammalian Cell Culture Production Toxin Alert operates a hollow-fibre bioreactor facility at the University of Guelph, capable of research and pre-commercial quantity cell culture production. The following services are available on industry-standard commercial terms. Growth Characterization Study - a time-lapse study of cell line growth, death and production; 2-3 weeks Serum-Free adaptation - culture is weaned off serum dependency in the feed media; 4 weeks Limiting Dilution Cloning - the culture is tested for stability and clonality; 2-3 weeks Isotyping Analysis - the culture is tested to evaluate the type of immunoglobin formed; 1 week Working Cell Bank Development - a 30-vial working bank is established, under which a GMP Master Cell Bank can be made; 2-3 weeks Roller Bottle Antibody Production - a quick source for less than 50 mg of antibody, includes diagnostic-grade purification; 2-3 weeks

Research-Scale Bioreactor Run - a 45-day run in a CP100 research-scale hollow fibre bioreactor, useful for quantities of less than 1 g; 6 weeks Purification of CP100 Run - diagnostic-grade purification suitable for further therapeutic-grade refinement; 1 week Production-Scale Bioreactor Run - a 45-day run in a CP2500 production-scale hollow fibre bioreactor, typically yielding grams of material; 6 weeks Purification of CP2500 Bioreactor Run - diagnostic-grade purification suitable for further therapeutic-grade refinement; 2 weeks pI Determination of Product - an isoelectric focusing analysis of the final product for comparative use or future purification optimization; 1 week SDS-PAGE Purity Assessment - 1 week