Using a closure analysis method to reduce CGT contamination risks
Many cell therapy manufacturing processes use open unit manipulations. As a result, they are at risk of potential contam...
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Addressing the challenges of using RNA as a therapeutic or a gene-editing tool
RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality due to their essential biological role in protein expression and their potential versatility in manufacturing. As a result, RNA is in the global spotlight and is being prioritized due to the Covid-19 pandemic. To maintain the current momentum as industry returns to a ‘normal’ cycle of drug and therapy development, BioPhorum experts have come together to...
Supporting particle investigations with risk-based decision-making
BioPhorum’s Visual Inspection workstream has invested considerable time and effort to add clarity to the uncertainty around how to assess the risk of atypical particles during investigations. The team’s Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products was recently published by BioPhorum and provides practical, risk-based guidance to support the decision-making process....
Using a closure analysis method to reduce CGT contamination risks
Many cell therapy manufacturing processes use open unit manipulations. As a result, they are at risk of potential contamination that can result in manufacturing batch failure. The processes therefore rely on end-to-end aseptic processing to ensure the final drug product is safe and free of potentially harmful contamination. Addressing these risks has led BioPhorum to publish Cell and gene therapy closed systems – closure analysis of a mock...
Bridging the worlds of IT and CGT through analogies
Cell and gene therapies (CGTs) have enormous potential to create personalized therapeutics for patients with diseases that were once untreatable – but they come with some challenges. Many of these are because the end-to-end process differs from conventional biologics and, crucially, requires new IT capabilities. When rapidly bringing new therapies to market, it is challenging to work out a practical IT architecture and investment strategy that...
How to replenish working cell banks with a risk-based scientific approach
Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. So, the availability of well-characterized cell banks capable of supporting manufacturing processes is critical for an uninterrupted drug product supply to patients and global markets. This is why two-tier cell banking systems are developed, consisting of master cell banks and...
How to make in-use stability and compatibility studies a success
In-use stability and compatibility studies are often used in biotherapeutic development to assess biologic drugs with diluents and/or administration components. The studies are done in conditions that are relevant for the target route of administration (usually intravenous, subcutaneous, or intramuscular) to ensure that patient safety and product efficacy are maintained during clinical use. To understand the current industry position on these...
Ask BioPhorum – a second brain for BioPhorum members
Whilst the filling and finish process is straightforward to describe, it is exquisitely complicated to get right and be assured and assure health authorities that the product reaches stringent quality standards. Even small deviations from standards can result in expensive losses and delay supply to patients of vital therapies. Experience and expertize matter. Ask BioPhorum is a valued member resource which enables subject...
Showcasing the NIIMBL-BioPhorum Buffer Stock Blending System
BioPhorum members have built a Buffer Stock Blending (BSB) System that will change the way buffer preparation is performed across the industry and significantly reduce the capital and operating costs of biopharmaceutical facilities in the future. Traditional buffer preparation requires substantial amounts of labor, capital, footprint, and time. The first edition of BioPhorum’s Biomanufacturing Technology Roadmap identified the potential...
BioPhorum’s Deliverables Report 2021 – all of our content at your fingertips
Where can you read about industry trends, progress against shared challenges, and best practice solutions for industry adoption? Where can you learn about benchmarking exercises, feedback to regulatory agencies, and industry position papers, all in one place? The answer? BioPhorum’s Deliverables Report 2021. The Report consolidates all the outputs produced by...
Why this SUS audit guide will reduce industry’s audit burden
In 2020, BioPhorum and Rx-360™ collaborated to develop a pilot program to assess that a Joint Audit Program® model was appropriate for use when auditing suppliers of single-use systems (SUS). The pilot was deemed a success and the model was found to be transferrable across companies with potential benefits around cost, audit burden, and resources for all stakeholders. The results were published in the Joint Audit Program ® – Pilot Program...