This paper has been written to address the compliance challenges of RTRT and the continued compliance with GMP standards. To evaluate these challenges, we have reviewed the current quality guidelines that apply to RTRT and considered the areas and activities that will be impacted by an RTRT process.
POI - Regulatory
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BioPhorum feedback on ICH Q14 and Q2(R2)
Sep 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Feedback to agency, POI - Regulatory, Regulatory, Regulatory Governance
This paper is the BioPhorum response to the recent ICH Q14 and Q2(R2) consultation. Overall, the first-draft guidelines seen by the team need to be less detailed in the main body of the documents but more specific to analytical methods. The documents must also be consistent throughout (across Q14 and Q2 and between the main body texts and examples). Further, detailed examples are needed for modalities other than small molecules (e.g., biologics, cell and gene therapies, etc.) as the small molecule examples are not relevant in some key respects. In the view of the BioPhorum team, the current documents will not drive a consistent understanding of regulatory expectations and the provision of information by industry to regulators.
Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version
Feb 2022 | Deliverable, Deliverables Report, Drug Substance, Feedback to agency, POI - Regulatory, Regulatory, Regulatory Governance
A comprehensive response to ICH Continuous manufacturing of drug substances and drug products Q13 draft version. The BioPhorum team overall think the draft reads well and believes the concepts and ideas are aligned with BioPhorum thinking on continuous manufacturing for biologic drug substance and drug product.
Industry feedback on USP bioreactivity draft monographs
Jan 2022 | Deliverable, Deliverables Report, Feedback to agency, POI - Regulatory, Regulatory
This BioPhorum paper contains feedback on the USP bioreactivity monographs to plastics used for manufacturing, and the use of resources. It also comments on the potential in vitro tests that should be included, the removal of the implantation test and safety, the removal of Class I to VI, and the topics for omission or inclusion into the <1031> chapter outline. The expert feedback provided in these documents aims to support the USP and, ultimately, produce documents that improve patient safety – but with adequate use of finite analytical resources, which would not be the case with divergent expectations.
Industry feedback on the bacterial endotoxin test (BET)
Jan 2022 | Deliverable, Deliverables Report, POI - Regulatory, Publication, Regulatory
This paper contains feedback on the USP document Bacterial Endotoxin Test (BET): A USP Comparability Study of Recombinant Reagents (Recombinant Factor C and Recombinant Cascade) to Lysate Reagents (LAL). The paper comments on issues such as the feasibility of testing the recommended matrix using four different recombinant reagents and four different lysate reagents, and that water post-deionization (low-purity) but before distillation/ultra-filtration (high-purity) is not representative of samples typically tested for bacterial endotoxins. It also questions whether industry will be able to provide known contaminated samples as these would be difficult to obtain and then compare.
Industry feedback on ICH Q12: implementation considerations for FDA-regulated products
Oct 2021 | Drug Substance, Feedback to agency, POI - Regulatory, Post Approval Strategies, Regulatory
The aim of ICH Q12 is clearly stated as a framework to facilitate the management of post-approval CMC changes. This document in the industry response to an agency consultation on draft guidance on ICH Q12. The biopharmaceutical industry through these comments commends the agency on leading the way to the implementation of ICH Q12. The BioPhorum comments are heavily influenced by the principle of simplification, which is why our views sometimes differ from the draft guideline.
Regulatory: Feedback to DMKA questions to critical GXP augmented intelligence
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BioPhorum response to work being conducted by The Danish Medicines Agency (DKMA) to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across GxP-regulated areas. The questions asked by the agency considered the requirements and quality of data used to build, test and validate an algorithm, and how it would respond to biases and deviations in results.
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Jan 2021 | Deliverable, POI - Regulatory, Publication, Regulatory
A dedicated task force, representing a collaboration between BioPhorum, the International Consortium for Innovation and Quality in Pharmaceutical Development (the IQ Consortium) and the Pharmaceutical Process Analytics Roundtable (PPAR) has come together to make an industry proposal to national regulatory authorities (NRAs) for standardizing the definition of models used in the manufacture and analytical testing of active pharmaceutical ingredients (APIs), drug
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Oct 2020 | BioPhorum, COVID 19, POI - Regulatory, Regulatory
This paper provides an in-depth exploration of the characteristics of SARS-CoV-2 (the virus) and COVID-19 (the disease). It also discusses how likely these may impact current control strategies that maintain product quality, safety and efficacy in the biopharmaceutical industry. It covers the areas that need to be assessed by biomanufacturers regarding SARS-CoV-2 risks for their patients, employees and products. Mitigation actions for the risks and associated benefits are also proposed. Just as importantly, it also discusses the areas that do not need to be evaluated – as current control strategies for endogenous and exogenous viruses, standards of work and the GMP framework are appropriate to prevent SARS-CoV-2 impacting on product. This is the case when the characteristics of SARS-CoV-2 do not make it unique when compared to the existing controls in place.