The BioPhorum approach to the registration of innovative raw materials using quality by design principles, explored the diversity of registration practices for innovative and complex materials and illustrated this through a survey of the current state. This appendix consists of an introduction to Protein A, the process followed for identifying critical material attributes, and controls and principles for registration that would offer future flexibility of supply.
Phorum of Interest
Viewing related articles
A structured approach for the evaluation, validation and implementation of NAT-based mycoplasma detection methods
Feb 2023 | Deliverable, Deliverables Report, POI - Technology Strategy, Publication, Rapid Methods for Adventitious Agents, Technology Strategy
This paper provides case studies and best practice guidance for validation of an alternative mycoplasma detection assay. It includes an example of completing a user requirement specification (URS) for evaluating an alternative mycoplasma detection assay, validation and implementation. Strategies are also provided to help identify suitable technologies for defined applications. Finally, a framework is given to demonstrate how a validation protocol for an alternative mycoplasma detection assay can be executed to meet the regulatory expectation that the alternative method is equivalent to or better than the current compendial methods.
How to keep quality control (QC) independent from production in the move to real-time testing
Jan 2023 | Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, POI - Regulatory, Publication, Quality Control
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.
Smart maintenance architecture – data-driven approach to smarter maintenance
Jan 2023 | Deliverable, Deliverables Report, Information Technology, POI - Information Technology, Publication, Smart Maintenance
This paper describes use cases and their technical solutions for implementation of predictive maintenance solutions in the biopharmaceutical manufacturing environment. Predictive maintenance is a significant component of smart maintenance which comprises extra elements such as smart use of computerized maintenance management software (CMMS), digital twin technology etc.
Rapid sterility test systems in the pharmaceutical industry: applying a structured approach to their evaluation, validation and global implementation
Jan 2023 | Alternative and Rapid Micro Methods, Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
This paper describes a systematic nine-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests which can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests. Two case studies are presented to illustrate the validation and implementation approach, including statistical methods.
100% inspection does not mean 100% defect detection
Jan 2023 | Deliverable, Fill Finish, POI - Fill Finish, Publication, Visual Inspection
The intent of this paper is to illustrate that the probabilistic nature of detection is well understood and it aims to dispel the misunderstandings associated with VI through illustrated examples and by highlighting that the probabilistic nature of inspection is recognized in multiple
regulatory guidance documents.
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.
The user requirement specification (URS) of the future
Dec 2022 | Deliverable, Deliverables Report, Drug Substance, Lean Qualification and Validation, POI - Drug Substance, Publication
The purpose of this paper is to stimulate debate in the biopharmaceutical industry and to work toward industry-wide alignment on the creation and use of optimized and lean user requirement specifications (URSs) for equipment, facilities, utilities and systems qualification.
Vision for digital maturity in the integration between biomanufacturers and partner organizations
Nov 2022 | Deliverable, Deliverables Report, Digital integration of sponsor and contract organizations, Information Technology, POI - Information Technology, Publication
Biopharmaceutical supply chains have evolved beyond single-source manufacturing to a complex network of collaborations and partnerships between sponsors and contract organizations. However, the expectations for deeper integration and visibility, automation and flexibility have increased and the lack of a standard framework has led to bespoke solutions which are unsustainable. This paper explains the current approaches to connecting biomanufacturing organizations, and the key benefits of improved digital integration. It articulates principles and patterns in the form of a simple maturity model that can be used to assess current state and plan for a more digitally aligned future.
Media fingerprinting of cell culture media a standardized analytical test method suite and three-tier approach
Nov 2022 | Deliverable, Deliverables Report, Drug Substance, POI - Drug Substance, Publication, Raw materials, Raw Materials Program, Raw Materials Sourcing
This paper gives a best practice recommendation for fingerprinting cell culture media. It includes a standardized analytical test method suite, a three-tier testing approach and flowcharts that guide the reader to choose a suitable media fingerprinting method based on their goals and the raw material properties.