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.
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.
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.
This BioPhorum member only survey validates the industry priorities for digital integration of sponsor and contract organizations
Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.
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.
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.
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.