Assay Archives

Characterization and risk assessment of host cell proteins using mass spectrometry

Nov 2022 | Benchmarking, Deliverable, Deliverables Report, Development Group, Host Cell Proteins and other Bioresidual Impurities

A BioPhorum member survey to gather preliminary information from across the biopharmaceutical industry on the characterization and risk assessment of HCP using mass spectrometry.

Enzymatic activity assays – general usage assessment

Nov 2022 | Benchmarking, Deliverable, Deliverables Report, Development Group, Host Cell Proteins and other Bioresidual Impurities

A BioPhorum member only survey to share knowledge into how, why and when enzymatic activity assays are performed.

Host cell protein risk assessment- Where we are with BioPhorum cross-company collaboration and what we have learnt from an industry perspective?

May 2022 | Conference, Deliverable, Deliverables Report, Development Group, Host Cell Proteins and other Bioresidual Impurities

A presentation on cross-company collaborative work and learnings produced from an industry perspective on host cell protein risk assessment. The presentation included a history of the HCP workstream, previous publications, planned future work and publication plans.

Challenges for potency assay development for in vivo and ex vivo gene therapies and the matrix approach

Sep 2021 | Cell & Gene Therapy, High Level Analytics, Publication, Regulatory Strategy

This paper highlights some of the challenges to develop potency assays for gene therapies and promotes a potential solution. It seeks to establish Industry alignment on the benefits of a matrix approach and provides high level guidance on how to adopt this strategy towards potency assay development and validation with examples for in vivo and ex vivo GT processes.

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Viewing related articles

Characterization and risk assessment of host cell proteins using mass spectrometry

Enzymatic activity assays – general usage assessment

Host cell protein risk assessment- Where we are with BioPhorum cross-company collaboration and what we have learnt from an industry perspective?

Challenges for potency assay development for in vivo and ex vivo gene therapies and the matrix approach

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