From antibody discovery to preclinical and clinical studies, understanding drug exposure, safety, and metabolism are essential in accelerating your programs path to clinic and commercialization.
Abzena develop, execute and document phase appropriate analytical methods necessary to produce highquality, wellcharacterized material and the data to support successful IND and marketing applications as you move towards commercialization.
Applying our expertise and experience, we develop rapid analytical data packages that support your regulatory approvals with all global agencies.
Our approach to analytical method development and validation focuses on developing and qualifying phase appropriate assays for a spectrum of safety, potency, purity, identity, and extended characterization. Our focus enables endtoend support for:
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Design and developability
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Cell line development
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Formulation development
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Upstream and downstream process development
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GMP manufacturing
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Release and stability testing for GMP material
Our global team of expert analytical scientists develop analytical test methods and analytical qualification protocols, leveraging stateoftheart instrumentation and a moleculespecific, customized approach to analytical method development, qualification, and testing.
Analytical methods can be developed de novo or transferred in from external laboratories.
We provide transparent and regular communications to ensure we meet your program goals and timelines. Our capabilities include:
- Viral clearance studies
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Titer/Productivity
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Purity/Identity
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Potency?
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Compendial?
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Extended Characterization Analyses?
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?Safety
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CellBased Assay Development
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Small Molecule Characterization?
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AntibodyDrug Conjugate Characterization?
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Instrumentation