The purpose of this paper is to stimulate debate in the biopharmaceutical industry and to work toward industry-wide alignment on the creation and use of optimized and lean user requirement specifications (URSs) for equipment, facilities, utilities and systems qualification.
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A BioPhorum member only survey to understand viral purification and clearance practices member companies are undertaking in CGT.
A BioPhorum member only survey is to gather information to benchmark what analytical controls member companies are currently using to establish methods to test identity, strength, potency and purity.
A BioPhorum member only benchmarking survey to understand the current challenges and strategies undertaking regarding leveraging process characterization data/use of platforms to accelerate validation.
Risk-based strategies to support revalidation and the assessment of requirements to maintain the validated state of equipment, process and facilities used for commercial and clinical manufacturing
This paper describes risk-based alternative strategies for defending the suitability of equipment and facilities requiring revalidation. These robust and risk-assessed approaches include real-time review, routine monitoring and in-/at-line alarms and measurements to help identify what data and testing are critical to assure the continued validated state of the equipment.
This paper highlights the numerous challenges in validating cell and gene therapy (CGT), drug substance (DS) and drug product (DP) manufacturing processes and analytical methods. It showcases some of the challenges associated with validation of viral vector-mediated gene therapy and gene-modified cellular therapy manufacturing processes and analytical methods validation and offers potential solutions for these. It aims to make readers more aware of the complexity and challenges associated with validating CGT products and the industry-wide consensus in addressing some of these to help drive regulatory acceptance.