This papers propose a pragmatic, simple and regulatory-acceptable solution to the supply shortage challenges it currently faces. It explores the diversity of registration practices for innovative and complex materials and illustrates this through a survey of the current state. The paper then offers a simplified harmonized approach for registration of materials, through a mature definition of product quality approach. This third case study in the series looking at increasing flexibility by a change in radiation for sterilization. However, the same mature approach to the definition of product quality that was used in the previous two papers is also used here. By reviewing the attributes of a material that are critical to product quality and assessing the potential risks linked to the change of sterilization method, the team was able to propose a consensual industry view on the change from gamma to x-ray sterilization for this family of products.
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Best regulatory practices for lifecycle management – registration of manufacturing controls
Sep 2023 | Deliverable, Deliverables Report, Drug Substance, Publication, Regulatory Governance
This paper summarizes some of the approaches taken by the biopharmaceutical industry to optimize and/or minimize the number of post-approval regulatory notifications and/ or the variation categories associated with product lifecycle changes. It offers a summary of the systematic approach used in the industry for the demonstration of product and process knowledge and the definition of the appropriate process controls that will also
allow future flexibility. This approach can mitigate supply issues that are prevalent in the industry by allowing easier transfers between sites, leading to significant benefits for the patients. There are no novel approaches described in the paper, instead this is a summary of current industry practice. It is intended that this paper is used to review current regulatory practices in existing organizations, and as a reference for new regulatory
professionals and organizations.
Impact of Annex 1 on container closure integrity
Sep 2023 | Container Closure Integrity, Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
This members only document serve as a reference document on the impact of Annex 1 on CCI for existing and new workstream members and is a collation of responses surveyed, narrative and notes made during discussions between SMEs and where applicable guest speakers.
A risk-based approach to filter integrity testing requirements for biologics drug substance manufacturers
Sep 2023 | Closed Systems in CNC Space, Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Sterile Filtration QRM & PUPSIT
Annex 1 of the EudraLex includes recommendations for filter integrity testing (FIT) of filters used for sterile filtration of sterile drug products. Manufacturers of low bioburden drug substances (DS) are seeking guidance on
the appropriate strategy for integrity testing of filters used in bioprocessing. The BioPhorum Closed Systems in CNC Spaces workstream developed a risk-based (and value-driven) approach for FIT testing of sterilizing grade filters used in the manufacture of low bioburden drug substances. This study yielded key criteria which served as the basis of a decision tree model for when and where FIT should be implemented to mitigate the risk of contamination. The findings of the study and the decision tree model were compared to current industry practice. Strong alignment was evident, suggesting the model could be used by DS manufacturers to develop a robust strategy for FIT which is congruent with regulatory guidance – specifically EudraLex Annexes 1 and 2. The risk-based approach is recommended to avoid dilution of effort on unnecessary FIT controls and target critical FIT use-cases that increase process reliability and patient safety outcomes.
Guidance for risk evaluation of X-ray irradiation of single-use systems
Sep 2023 | Deliverable, Drug Substance, POI - Drug Substance, Publication, Supply Partner
This guidance document and the accompanying XI risk evaluation tool define the BioPhorum approach to risk evaluation of X-ray irradiation for sterilization of single-use systems (SUS) and is a flexible resource for incorporation of supporting tools into end-user quality system documents. End-users are responsible for critically reviewing this content prior to application and selecting the aspects that are most aligned with internal procedures, as well as making refinements as needed to meet local requirements.
Closure Playbook – introduction
Sep 2023 | Closed Systems in CNC Space, Drug Substance, POI - Drug Substance, Publication
This paper describes the tools, steps, and documents required to assess risk and qualify biomanufacturing facilities that use closed-system technologies. It sets the scene for closed systems and discusses the right approach, tools, and methods of implementing them in appropriately operated and non-classified zones. This is the first chapter in a series to be published over Q4 2023 and throughout 2024. Subsequent chapters will include the general philosophy of closed systems, standard terminology, and how to apply the risk assessment model.
Biosafety risk assessment template for manufacturing and processing of biological materials
Sep 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, EHS, EHS and Biosafety, POI - Cell and Gene Therapy, Publication
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CGT safety data sheet template
Sep 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, EHS, EHS and Biosafety, POI - Cell and Gene Therapy, Publication
A downloadable template for CGT institutions to use to communicate workplace hazards and assess the risks posed by CGT materials.
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Aug 2023 | Cell & Gene Therapy, Deliverable, Deliverables Report, PAT Monitoring and Control, POI - Cell and Gene Therapy, Publication
This BioPhorum commentary summarizes the CGT industry views on PAT articulated during the virtual event, and highlights key takeaways on the benefits and barriers to PAT, unique considerations for PAT in the context of CGTs, and highlights some near-term options to help accelerate these important therapies to patients prior to implementing PAT.
User vision for the filling line of the future
Aug 2023 | Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
This paper from the BioPhorum Commercial Lines of the Future team provides an overview of the future needs of the industry for aseptic manufacture and will inform and assist equipment providers in developing the appropriate technology. It is divided into general and detailed requirements. The general requirements are capability and capacity, and the detailed requirements are decontamination, filling, environmental monitoring, component handling, and connectivity.