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PAT evolved As Pharma 4.0 becomes reality, there is more to PAT than QC/QA

28 April 2023 No Comments

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.

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Advancing PAT Solutions for the Bioprocessing Industry

28 April 2023 No Comments

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.

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HPAPI Cleaning validation considerations – Part 2

26 April 2023 No Comments

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.

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Transitioning to a circular bioeconomy: Key drivers and the new cluster technologies to accelerate process development in biotechnology sectors

26 April 2023 No Comments

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.

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Continuous flow photochemistry and green chemistry

26 April 2023 No Comments

The union of continuous flow processing and photochemistry has enabled the effective generation of target molecules of ever-increasing complexity and with growing selectivity. Inherent benefits of flow reactors are thereby exploited for better heat and mass transfer, containment of high energy light as well as scalability irrespective of reactor footprint. This short perspective article evaluates the advances of continuous flow photochemistry towards greener chemical synthesis and highlights remaining challenges that will need to be resolved to meet our sustainability goals.

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Contemporary chiral resolutions

26 April 2023 No Comments

Isolation of enantiomerically pure materials from the corresponding racemates is an ever-challenging endeavour. Many techniques have been developed over the years to increase the efficiency and improve the success rate. The isolated yield is limited to the maximum amount of enantiomer in a racemate, namely 50%. Using (in situ) racemization, the yield can be boosted to a theoretical 100%. This article provides contemporary resolution techniques that facilitate the isolation of the desired enantiomer in the most efficient manner via crystallization.

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