Regulatory Archives

BioPhorum comments on proposed national emission standards for hazardous air pollutants ethylene oxide emissions standards for sterilization facilities residual risk and technology review

Jul 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Feedback to agency, Fill Finish, POI - Supply Partner, Publication, Regulatory, Supply Chain to Patient, Supply Partner, Sustainability

This group supports the Environmental Protection Agency’s (EPA) efforts to protect public health and the environment through the Residual Risk and Technology Review (RTR) process and recognizes the
need to develop stringent emissions standards to mitigate any potential hazards posed by Ethylene Oxide (EtO) emissions. However, they are also cautious of the impact these changes may have on the availability and timely delivery of biotherapeutics to patients who rely on them. Biotherapeutics, including vaccines, therapeutics, and other life-saving medications, play a crucial role in improving patient health outcomes and saving lives. For the biopharmaceutical industry, EtO sterilization is a critical process used to ensure product safety and efficacy. The EtO Response team raised several concerns regarding the potential impact of the proposed rule changes on the biotherapeutics market. This document discusses the concerns.

BioPhorum feedback on ICH Q5A (R2)

Mar 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Feedback to agency, POI - Development Group, Regulatory, Regulatory Governance, Supply Partner

BioPhorum’s in-depth feedback includes 70 line-by-line, detailed comments, including the rationale for the points and any proposed changes/recommendations that are deemed necessary by the team to ensure a harmonized implementation across industry and regulatory agencies.

BioPhorum environmental sustainability roadmap 2022

Dec 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, MediPhorum, POI - Sustainability, Publication, Regulatory, Supply Chain to Patient, Supply Partner, Sustainability, Technology Strategy

Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health. The healthcare sector is responsible for 4–5% of global emissions, more than 70% of which are driven by supply chains.

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.

Webinar PACMPS for LATAM

Jul 2022 | Regulatory

BioPhorum was asked to step in and bring its global collaboration experience to the table in order to pave the way for regulatory harmonization and see greatly shorter timescales for post-approval changes. The webinar communicates post-approval change management protocols for LATAM. Experts in the industry present the principles, process, case studies, and benefits to agencies and patients.The presentation is given in Spanish, slides are...

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.

BioPhorum approach to the registration of innovative raw materials using quality by design (QbD) principles

Jan 2022 | Deliverable, Drug Substance, POI - Drug Substance, Publication, Raw materials, Regulatory

BioPhorum has defined a best practice approach to the registration of innovative and complex raw materials. The approach is based on quality by design(QBD) principles. It is applicable to different families of non-compendial raw materials in the manufacture of biologics. The approach has already been used by BioPhorum member organizations and accepted by national health authorities.

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.

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