Biologics Analytical Services



Methods Management

Analytical flexibility for method development, optimization, transfer and verifications.

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Catalent has vast experience in helping you with your method management needs to support the development of your program including method developments, method optimization, method transfer, and phase specific method validations and method verifications.  Methods include Physico-chemical assays, Functional/Potency assays, Binding Assays, Molecular Biological assays, and Microbiological assays

Method Development / Optimization
  • Catalent provides expertise in developing methods at any stage of the program development process, both for GMP and characterization needs.  Our scientific experts stay current to the regulatory and technological changes in the industry.  This allows the scientific staff to provide our clients with well developed strategy for their project needs to support subsequent phases of the project.  This knowledge will be used to guide, customize, and execute the method development plan in an efficient manner to meet client’s requirements and timelines.
  • Catalent can provide method optimization as part of method lifecycle management whether it is to complete development of a method that has not been fully optimized, or to optimize methods along the development program in response to manufacturing changes, formulation changes, and method robustness issues.

During method development and optimization, progress/status updates are provided on regular basis.  Catalent encourages regular teleconferences to facilitate dialogue behind method development/optimization.

See Analytical Techniques for listing of assays for which Catalent can provide method development and optimization support.

Method
  • Routinely, Catalent meets clients’ needs to transfer testing activities from other laboratories to Catalent or vice versa.  Catalent provides method transfer services to support characterization methods as well as GMP clinical/commercial release and stability testing.
  • Method transfers for GMP clinical/commercial release and stability testing are performed under protocols with both client and Catalent approvals.  Regular updates are provided regarding the transfer activity progress.

See Analytical Techniques for listing of assays for which Catalent can provide method transfer support.

Phase Specific Method Validations / Verifications
  • Catalent has a strong background and experience in providing method validation appropriate for all phases of drug development, whether Phase I/II validation/qualification or Phase III/NDA/BLA/MAA validation as per ICH guidelines across many assay formats (see Analytical Techniques).
  • Method Validations are performed under protocols with both client and Catalent approvals.  Regular updates are provided regarding the validation activity progress.  Due to deep experience across the multiple scientific disciplines, Catalent can provide robust validation strategies in consultation with client.  Execution of method validations are monitored and performed to meet clients’ requirements and timelines routinely as part of our commitment to on time in full delivery.
  • Phase specific method verifications are provided for pharmacopeia methods (US/EU/JP) for microbiological assays and for physico-chemical assays, as appropriate.  See Analytical Techniques for listing of compendial assays

See Analytical Techniques for listing of assays for which Catalent can provide method transfer support.

Methods Lifecycle Management
  • Catalent can provide continuous method evaluation throughout project lifecycle (development phases to post commercial) that includes offering advanced and/or alternative techniques to improve the existing method or provide orthogonal methods to support analysis.

See Analytical Techniques for a listing of method options to support method lifecycle.