This paper describes a systematic nine-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests which can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests. Two case studies are presented to illustrate the validation and implementation approach, including statistical methods.
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The user requirement specification (URS) of the future
Dec 2022 | Deliverable, Deliverables Report, Drug Substance, Lean Qualification and Validation, POI - Drug Substance, Publication
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.
CGT Viral clearance validation aspects
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Supply Chain to Patient, Validation
A BioPhorum member only survey to understand viral purification and clearance practices member companies are undertaking in CGT.
CGT method validation controls bench-marking survey
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Validation
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.
CGT Leveraging process characterization data to accelerate validation bench-marking survey
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Validation
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
Sep 2022 | Deliverable, Deliverables Report, Drug Substance, Multi-Product Facility, POI - Drug Substance, Publication
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.
Cell and gene therapy validation challenges
Aug 2021 | Cell & Gene Therapy, Commercialization, Deliverable, POI - Cell and Gene Therapy, Publication
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.
Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper
Sep 2018 | Fill Finish
The release of the expanded USP<1207> in 2016 cast doubt over the validity of so-called probabilistic analytical methods, including one the biopharmaceutical industry’s most universal tests – the dye ingress method for container closure integrity
With the dye ingress method ubiquitously used without issue for decades, this paper highlights the continued value and applicability of this and other probabilistic analytical tests. In addition, this paper also describes how any method, whether probabilistic or deterministic, stands or falls on the quality of its development and validation, and not necessarily on the properties of the test itself.
The most important factor is to apply a test method is not how it is labelled, but lies in its development, qualification and whether it meets the need for which it is designed.
Container closure integrity (CCI): Container closure integrity control versus integrity testing during routine manufacturing
Jun 2015 | Fill Finish, POI - Fill Finish
In 2014 uncertainty around regulation for container closure and integrity testing (CCIT) fed a perceptible shift in mindset across the industry, causing some concern amongst many subject matter experts in biological manufacturers. Their concern was that gaps in guidance was enabling skewed expectations such that they would promote 100% CCIT for the release of drug product batches. This paper addresses this concern by re-stating the principles of CCI, qualification, process control and in-process testing to establish the framework within all effective container closure integrity programs. It concludes that performing 100% CCIT does not provide certainty that a process is well controlled and introduces an additional step that is not always necessary or suitable for the high processing speeds in the industry.