Regulatory

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Here’s how BioPhorum’s ‘one voice’ is helping industry save $millions in Colombia

Imagine a situation where post-approval changes took 18–24 months to be reviewed. Think about the impact on biomanufacturers who would need staggered timelines for implementing changes across different markets and different products. And their need for complex processes that affect inventories, time, money, resources, security, compliance, etc. This was the picture facing biotherapeutic importers into Colombia because its health agency, INVIMA,...

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Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics

Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and drug products have achieved this in many cases, biologics are behind the global implementation of CM because of their more complex manufacturing processes.  However, the regulatory agency members of the International Committee for Harmonization (ICH) now have enough experience in the registration,...

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Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

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.

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The four steps for registering innovative and complex raw materials

The Covid-19 pandemic has put extra strain on an already stretched biopharmaceutical supply chain. As industry has grown exponentially over the last couple of years, there has been an increased demand for materials and many existing products share these with the new Covid-19 vaccines, testing kits and therapies. As a result, these materials have been diverted to this high-priority use.  The pandemic has therefore demonstrated that reliance...

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Collaborating with USP on its Bacterial Endotoxin Test Protocol and Bioreactivity Draft Monographs

With a clear objective of setting standards for the industry and protecting patients worldwide, the USP is a key partner of BioPhorum. Ensuring that the industry position defined through the BioPhorum collaboration is reflected back to the USP is also one of BioPhorum’s key objectives.  Two recent documents typify BioPhorum’s approach to this collaboration and how it provides expert feedback on consultations.  Industry feedback on...

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Driving industry consensus on the EU’s Medical Devices regulation

The EU Medical Device Regulation (MDR) Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices. The regulation is particularly unclear in the case of a device constituent part being classified as an invasive device, and whether all drug product contacting components must conform to the requirements for invasive components. There are also...

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Industry feedback on USP bioreactivity draft monographs

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.

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Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper

The EU MDR Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices. The regulation is particularly unclear in the case of a device constituent part being classified as an invasive device, and whether all drug product contacting components must conform to the requirements for invasive components. There are also ambiguities regarding requirements such as notified body opinion and human factor study requirements. This paper presents an industry position statement and illustrates the concerns.

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Industry feedback on the bacterial endotoxin test (BET)

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.

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Feedback on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial

This member document summarizes consolidated feedback and recommendations from a collaboration of BioPhorum members on the FDA draft guidance for industry studying multiple versions of a cellular or gene therapy product in an early phase clinical trial consultation.

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