Data integrity is fundamental to comply with current good manufacturing practices (CGMP) and ensure patient safety. Unsurprisingly, quality control (QC) lab data are heavily scrutinized during audits as they directly support the quality, safety and efficacy of the product, and indicate the state of control of a facility. Most QC labs have worked hard to establish the fundamentals of data integrity. Many have digitized to eliminate paper, some systems have compliance features built in, and a series of mitigations and workarounds cover the rest, albeit with some inefficiencies and limitations. There have also been significant evolution of systems and business practices, rising expectations for efficient and thorough investigation capability, and the desire to go beyond compliance and get knowledge and insights through better access to data. Next steps in data integrity are key to the QC lab of the future and the digital maturity of the manufacturing capability as a whole.
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CGTs and their patient-specific delivery of therapeutics are seen by many as the future of medicine. However, the field of CGT manufacture is currently immature and typically involves multiple organizations in the delivery of a single CGT treatment. As well as the established biomanufacturers, there are many small players who are attempting to scale up from lab-based processes. Many of these CGT companies are working to establish their IT requirements, but there is no common understanding of a pharma company’s ‘normal’ CGT needs or those of the multiple organizations and experts involved.
This document contains a set of reference models explaining who needs to be involved in the supply of different types of Cell and Gene Therapies (CGTs) and, at a very high level, what they do. It can be used by anyone who wishes to better understand the manufacture and delivery of CGTs, and in
particular how IT systems can support that.
The purpose of this document and action plan is to articulate AR/VR hardware and software requirements; stimulate collaboration between biomanufacturers and vendors of AR/VR hardware and software and help vendors of AR/VR hardware and software construct roadmaps to unleash the potential of this technology in GMP environments.
The benefits of progressively more sophisticated lab instrument integration in the quality control labs
QC labs play a key role across biopharmaceutical organizations to ensure product quality and patient safety. However, they have yet to achieve full digital maturity. Poor digitalization and integration have led to many non-optimal solutions for labs, such as workarounds and tailored solutions that are too expensive to upgrade. Often teams cannot take advantage of the latest innovations. With the help of this document, advocates for change can persuade other stakeholders to raise their game by showing the opportunity for significant benefits. The origins of this analysis in cross-industry collaboration and alignment represent a weight of common intent that should not be ignored.
The purpose of the MES of the future manifesto is a call to action from the biomanufacturing industry to vendors of MES solutions. The manifesto articulates: the gap between the current generation of MES solutions and the needs of the biomanufacturing industry and a realistic and achievable vision for the MES of the future that will meet the needs of the biomanufacturing plants of the future. It is intended to stimulate collaboration between biomanufacturers and vendors of MES solutions that will outline roadmaps for future development.
IT can be simple: Using analogies to facilitate collaboration on the IT challenges of supplying cell and gene therapies
Cell and gene therapies (CGTs) are medicines with enormous potential to create personalized therapeutics for patients with diseases that were once untreatable. However with these opportunities come challenges. One is how IT and CGT teams understand each other’s needs and challenges – only once this knowledge gap is bridged will CGTs be produced and administered commercially. This paper uses analogies to help specialists from CGT and IT to discuss and understand the key issues in commercializing CGTs and important aspects of IT systems and infrastructure. The analogies also reveal those differences in a relatable way that stimulates creativity and joint problem solving, which are critical in this fledgling but fast-growing industry.
A member only survey looking at how users are adapting the DPMM to meet their needs.
A BioPhorum members only draft document intended to support maintenance and IT teams install/upgrade systems to be ready for smart maintenance in validated environment
BioPhorum member only briefing document for working with suppliers on CMO integration, outlining the problem statement and benefits.