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...
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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.
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.
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.
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.
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.
This guidance document identifies the relevant change areas, and for each area, exemplifies the type of changes which the biopharmaceutical industry needs to be informed about. It also lists the required information, in terms of supporting data and documentation, to support notification of changes. This guidance is relevant to all raw materials used to produce biopharmaceutical products, including but not limited to cell culture media, fermentation broth components, column resin, buffers, solvents, and excipients. By highlighting the changes biopharmaceutical industry end-users need to know about and specifying the information required, the intention of this industry-aligned guidance is to reduce the quantity of rework required and the time taken to process change requests. In turn, this will reduce variability in demand patterns as end-users refrain from building extensive inventories to mitigate against the perceived risks which arise from proposed changes. While complete alignment and standardization on the information which should be provided for changes is not possible, a more robust alignment on the typical information required, as set on in this guidance, will significantly improve the current state.