Stand-Alone Analytical Services for Biologics, Bioconjugates & Advanced Therapies

Method Establishment

Abzena offers full lifecycle support for each method to ensure they are set up to be fit-for-purpose. We can customize the strategy based on project need for each method and stage. The following activities are performed to support the appropriate establishment of the method:

Initial Method Setup:

➔ Method Development
➔ Method Evaluation
➔ Method Optimization

Upon completion of initial method setup activities, the following GMP enabling activities can be performed as needed:

Compendial Method Phase Appropriate Verification
➔ Method Transfers
➔ Method Qualification/Phase I/II validation
➔ Method Validation (Phase III/BLA)

Product-specific methods are issued for all assays to ensure methods have complete and thorough details specific to the product material.

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Stability Programs

At Abzena, we can support ICH-compliant GMP and non GMP stability studies. All chambers are qualified, on emergency backup power, monitored by building management system, have multiple redundant conditions at each site and redundancy across our sites – Bristol, PA and San Diego, CA; The following conditions are currently provided to support large-molecule drugs:

➔ – 80° ± 10°C
➔ -20° ± 5°C
➔ 5° ± 3°C
➔ 25°C ± 2°C / 60% ± 5% RH
➔ 40°C ± 2°C / 75% ± 5% RH

Example stability studies include:

➔ Development /Prototype
➔ Clinical
➔ Commercial
➔ Freeze/Thaw
➔ Photostability
➔ In-Use
➔ Reconstitution

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