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Published on : Mar 14, 2014
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Slide 1 - Kurt Brorson, Ph.D. Division of Monoclonal Antibodies OPS/CDER
Slide 2 - Biopharmaceuticals are complex- more potential heterogeneity than small molecule drugs
Slide 3 - Heterogeneity in recombinant products and Monoclonal antibodies Cell culture related Fermentation is an artificial process vs. plasma or other natural sources Bioreactor conditions can impact: Glycosylation Some charge variants Amino acid substitutions (leu  norleucine, etc) The cell line can impact: Adduct placement Folding/misfolding Cysteine pairing
Slide 4 - Heterogeneity in recombinant products and Monoclonal antibodies Stability related Pure, high concentration protein is an artificial system vs. proteins in cells or bodily fluids Plasma and recombinant products face same challenges Clipping Aggregation Deamidation (Asn  Asp; Gln  Glu; loss of e-NH2 on Lys Oxidation (Met  Met sulfoxide)
Slide 5 - Antibody Heterogeneity- Major role of glycosylation, C-terminal lys K K
Slide 6 - Expected Heterogeneity-experience with monoclonal antibodies C terminal lysine variability occurs in most monoclonal antibody products Manufacturers set acceptable ranges for each species Can be measured by various techniques, wCEX-HPLC, IEF, others Doesn’t seem to impact potency or safety profile
Slide 7 - Monoclonal antibodiesUnacceptable, stress induced heterogeneity Detectable by various methods Manufacturers set stability specifications Can compromise potency if OOS
Slide 8 - Heterogeneity-experience with other recombinant products Case 1: protein terminus heterogeneity Traced to metaloprotease Minimal impact on potency Case 2: product clipping Minimal impact on potency Case 3: N-terminal glutamine cyclization Cyclized form had increased activity
Slide 9 - Strategies to maintain product quality Testing- lot release & stability Employ a range of assays IEF, wCEX-HPLC- charge variants Tryptic peptide mapping, N & C-terminal sqxing- amino acid sequence variants, oxidation, adduct formation SDS-PAGE, SEC-HPLC- clipping, aggregate formation Mass spectroscopy- molecular weight changes Specialized assays- carbohydrate analysis, IsoQuant, others Set acceptable ranges for quality attributes Based on clinical & manufacturing experience
Slide 10 - Strategies to maintain product quality Formulation, purification and storage- minimize change over time Formulation Lyophilization vs. liquid pH control Stabilizers (sugars, polyhydric alcohols) Surfactants N2 overlay in vial Product attributes: Residual enzymes Some metals (Cu++, etc.) Storage Correct temperature Minimize O2, bubbles in vial Protect from light
Slide 11 - Strategies: assessment of impact If heterogeneity can’t be avoided… Control it Does heterogeneity impact API potency? Is it near effector parts of protein? Assess via potency assay Does heterogeneity impact bioavailability? Major glycoform changes Assess in PK studies Does heterogeneity impact immunogenicity? Placement, type, extent of substitutions Sometimes assess in immunogenicity studies Case dependent