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BioReliance® Product Characterization Services

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mAb Stability Program

Are you confident in your drug’s ability to withstand various uncontrollable environmental factors? Get answers with our stability testing solutions for product development. Our program will demonstrate the short- and long-term stability of a biologic after exposure to various environmental conditions, such as temperature, humidity, light, freeze/thaw cycles, and container/closure interactions.

Successfully Release your Product to Market

Integrated within a standard stability package is an accelerated stability program designed to gain quick insights into your drug’s expiration date by subjecting your product to an elevated level of stress. Successfully completing this accelerated program allows you to release your product to market. All stability studies are conducted in a GMP environment, and all assays are performed to meet ICH guidelines; assays qualified as GMP when required.

mAb Stability Assays, Conditions, and Timepoints

Our multi-year stability program includes the following assays performed at a range of ICH stability conditions:

Standard Assays

Appearance (clarity, color, visible particle), pH, sterility, sub-visible particle, protein concentration (280), SEC-UHPLC, RP-HPLC, SDS-PAGE (reduced & non-reduced), binding (ELISA), in vitro bioassay, cIEF, CE-SDS (reduced & non-reduced), IEC, container closure integrity, bioburden, endotoxin, Karl Fisher moisture analysis, ligand-binding (SPR), osmolality, peptide mapping, reconstitution time

Stability Conditions

-80°C (-65°C to -90°C), -20°C (-15°C to -25°C), 5°C (2°C to 8°C), 25°C (60% RH), and 40°C (75% RH)

Time points (months)

0, 1, 3, 6, 9, 12, 15,18, 24, 30, 36, 42, 48, 54, 60

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Contact our product characterization experts to discuss your specialized needs and take the next step to securing the future of your biotherapy.

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