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Phase appropriate approach to assay validation

17 January 2024
Advanced Therapy Medicinal Products
Phase appropriate approach to assay validation
68.15 MB
666 downloads

A phase-appropriate approach to assay validation continues to be a widely accepted and adopted strategy to support the clinical development of general biologics; cell and gene (CGT) therapies are no exception.

However, current regulatory guidance is inadequate for sufficiently guiding and supporting the phase-appropriate readiness of analytical assays used in all phases of CGT clinical development and regulatory filing.

This insufficient clarity has led to a lack of consensus within the cell and gene community for the phase-appropriate development and validation of the analytical assays utilized at all phases of the CGT product lifecycle.

In this presentation, members of BioPhorum Advanced Therapy Medicinal Products present their consolidated opinions and recommendations to promote alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common CGT modalities. The team’s recommendations are aimed at providing a faster and more efficient route to CGT product development that is compliant with the regulatory standards.

The slides cover:

  • The product and methods lifecycle, including analytical method bridging (with examples)
  • The regulatory landscape – guidelines associated with analytical methods development and validation
  • Determining a phase-appropriate approach to assay validation, including recommendations for the scope of method qualification.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

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Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

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Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

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Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

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BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

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Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

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Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

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Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

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Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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