Elevating pharmaceutical manufacturing processes with real-time insights
4 December 2023
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(Bio)pharmaceutical manufacturing is changing considerably, with key innovations enabling companies to rethink R&D, manufacturing, quality control and quality assurance (QC/QA) operations. The spotlight is squarely on process analytical technology (PAT), which underpins the successful transition towards highly effective advanced manufacturing strategies. Martin Gadsby, Chairman of Optimal Industrial Technologies, looks at how this transformative approach is making advanced manufacturing practices more accessible thanks to the latest developments in instrumentation and data-oriented solutions.
The (bio)pharmaceutical industry is currently facing numerous hurdles in its path to high-efficiency production that are more complex and pressing than ever before. One of the most significant perceived challenges is the ability to implement new innovations and increase productivity while adhering to stringent regulatory demands. The race to develop new drugs and therapies demands rapid drug discovery, testing and time-to-market. To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety.
PAT has emerged as a game-changer to drive performance, traceability and regulatory compliance, helping the sector overcome current limitations and embrace new strategies while futureproofing it in line with Industry 4.0 principles. This is a systematic approach that harnesses the power of data and leverages real-time analysis tools to closely monitor and control critical process parameters (CPPs) and their relationship with critical quality attributes (CQAs). As a result, PAT enhances process understanding and regulatory compliance while ensuring consistent product quality. More precisely, real-time monitoring allows for meticulous scrutiny of data against predefined parameters. Should the need arise, adjustments to the process can be seamlessly made either manually or automatically, ensuring the production of high-quality goods with unmatched efficiency.
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