The Biologics Manufacturing Asia trade show, known as BMA 2023, prides itself on showcasing the latest innovations driving the APAC biologics manufacturing industry, and at this year’s event in Singapore, there were plenty of networking and technical discussions around that subject.
At the mid-March event, there were over 1,000 attendees, 300 companies, 60 speakers, and 50 case studies focused on the latest biotech manufacturing technologies. The show website named several topics that were discussed and demonstrated such as “single-use and end-to-end continuous processing for biologics, today’s challenges and opportunities in biomanufacturing, advances in upstream process development, cost-optimization strategies in downstream processing, analytical characterization strategies, facility design, and scale-up strategy, fill & finish innovation to streamline the operations amongst other crucial themes.”
Attendees who stopped by our booth were interested in Process Analytical Technology and automated real-time process monitoring, as many of them are still using manual methods.
Process Analytical Technology (PAT), which is a regulatory framework initiated by the United States Food and Drug Administration (FDA), encourages pharmaceutical manufacturers to improve the process of pharmaceutical development, manufacturing, and quality control. PAT aims to improve process efficiency and process control by defining Critical Process Parameters (CPP) and monitoring these CPPs to stay within a defined limit, either in-line or on-line to maintain a product’s Critical Quality Attributes (CQA).
We demonstrated two PAT categories and resources at the show, including off-gas analysis using process mass spectrometry and metabolite monitoring using Raman spectroscopy. Controlling manufacturing by testing and measuring during the processing of critical quality and performance attributes of raw and in-process materials helps ensure final product quality. Real time off-gas monitoring provides insightful data that can be used to determine metabolism. Process mass spectrometers can help track fermentation and cell culture processes in real time and help produce quantitative solvent drying data to optimize the drying process. Process gas analysis technologies deliver lab-quality online gas composition analysis and help maximize product yield and profitability.
Monitoring CPPs with process mass spectrometry gas analysis reduces over-processing, pinpoints contaminants and increases product consistency. In some cell culture analysis, like mammalian cell fermentations, the feed gas composition is a frequently changing mixture of several compounds. The feed gas concentration also ranges vary dramatically. The implementation of real-time, off-gas analysis using process mass spectrometry in mammalian cell culture can help identify process deviations during bioreactor runs and evaluate batch to batch variation, within predefined specifications, for robust manufacturing.
In biopharmaceutical production, cells require a feeding cycle of glucose to enable cell reproduction. A process analyzer utilizing Raman Spectroscopy leverages compact and simplified hardware along with data science tools to model the glucose content of a bioprocess and tell you exactly when to add more glucose to ensure cell production at a precise rate.
Another technology that has been effectively deployed by the pharmaceutical and biotech industry to identify and quantify unknown materials is a molecular analysis technique called Raman spectroscopy. Using this technology, an unknown sample of material is illuminated with monochromatic (single wavelength or single frequency) laser light, which can be absorbed, transmitted, reflected, or scattered by the sample. Light scattered from the sample is due to either elastic collisions of the light with the sample’s molecules (Rayleigh scatter) or inelastic collisions (Raman scatter). Whereas Rayleigh scattered light has the same frequency (wavelength) of the incident laser light, Raman scattered light returns from the sample at different frequencies corresponding to the vibrational frequencies of the bonds of the molecules in the sample.
Luckily, some of these technologies are designed for out-of-the-box use, enabling one to take highly accurate Raman measurements at the point of need in less than 15 minutes, and can be easily integrated into existing process monitoring and eliminates the need for costly technical expertise.
If you weren’t able to make the show, and want to learn more about these and other applied technologies to improve pharmaceutical and biotech manufacturing processes, just visit our website. Don’t wait for next year’s show (date and place to be determined).
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