Amplexor’s closest industry partners and BE THE EXPERT event speakers review the major milestones in the Life Sciences Regulatory sphere in 2022 and predict developments for 2023.
As the global Life Sciences market experiences ongoing disruption to international supply chains, this has created turbulence and consolidation for brands and manufacturers as they grapple with the complexity of ensuring safety and quality. As companies strive to build confidence in their end-to-end safety profile, Arriello’s Helen Lowe examines how they can ensure quality without boundaries.
New waves of innovation in Life Sciences, and a redoubled effort by regulators to maintain patient safety, are placing increased pressure on drug and device manufacturers to assure the consistent standards across manufacturing processes, systems and supply-chain partnerships. After practical supply chain issues in 2022, added to the impact of continued medicinal/device innovation, 2023 will bring new regulatory changes linked to process digitalisation and automation. REPHINE’s Dr. Eduard Cayón discusses the implications.
Process Analytical Technology (PAT) has undergone rapid developments since its foundation, substantially redefining how it can be realised and the gains it can deliver to companies in the (bio)pharmaceutical sector. Thanks to key advances in digital technologies, it is now possible to enhance more than quality control and assurance (QC/QA) activities. Simultaneously, as companies take steps forward to succeed in the creation of Industry 4.0 applications, they are shaping new frameworks and driving new trends. Interoperability and convergence to realise the Industrial Internet of Things (IIoT) is one of the most prominent aspects that future-oriented PAT solutions are addressing. Similarly, advanced data analytics capabilities to improve process control and equipment condition monitoring in addition to more automated decision-making to drive responsiveness on the shop floor and in the laboratory as well as inter-facility standardisation are also in high demand and supported by the latest PAT applications.
There is a strong drive to explore and implement new tools for process analytical technology (PAT) in biopharmaceutical drug development and manufacturing. Their implementation facilitates real time monitoring and control of critical quality attributes (CQAs) and critical process parameters (CPPs) throughout the discovery, development, and manufacturing of biologics. Having access to high performing and comprehensive analytics render in better process understanding, improved operational robustness and reduced risk of costly batch failures. Streamlined and easy-to-use instrumentation for liquid chromatography (LC) and mass spectrometry (MS) allow bioprocess engineers to take control of cell culturing and process developments with their own high-quality and high-confidence data without being an MS expert.
On September 27-29 the 13th CFRT for Industrial Applications Symposium took place at
Tanya Murphy is Associate Director of Compliance at AstraZeneca, where she is responsible
In general, Cleaning Validation (CV) is very complicated topic. The complexity is not only maneuvering within a site’s CV program, but also between industries (i.e., small molecule, biopharma, and API/finished product manufacturing). Regulatory guidelines discuss CV topics in general but specifically to any industry. Therefore, deciphering and implementing their recommendations or expectations is often difficult.
Because High Potent Active Pharmaceutical Ingredient (HPAPI) manufacturing is very high-risk from a patient safety perspective, every stage of the CV (from development to periodic monitoring (PM)) requires additional considerations and evaluation.
A thorough assessment of every stage of the HPAPI CV process was performed. This resulted in considerations, recommendations and solutions; which are published in this article.
The assessment of adverse effects on the health on professional workers potentially exposed to
There is growing interest from governmental organizations and firms in the biotechnology sector in transitioning to a circular bioeconomy to meet their climate and economic goals. We use data from a recent presentation given at the CPAC Rome Workshop 2023 (30, 31) to present five key factors driving the transition away from carbon-based materials to biobased ones and the technologies that are being implemented to achieve this. We address some of the new challenges that have arisen such as long wait times at the process development and commercialization stages. Finally, we offer solutions through the implementation of organizational clusters to overcome the challenge of resource efficiency through geographical proximity, and knowledge transfer.
