Many of the presentations on the first day of Manufacturing Chemist Live were focused primarily on high potency active pharmaceutical ingredients (HPAPIs) and in particular, the challenges of handling and containing them. Other topics, including emulsification and wet granulation, were explored in detail as well.
On HPAPIs, Lonza and Dr. Reddy’s Laboratories explained in depth both formulation strategies for drug development, in addition to development and scale up strategies for manufacturers. Lonza’s Frederique Bordes-Picard and Patrick Andreux emphasised the benefits of liquid-filled hard capsules for the delivery of high potency drugs, including the reduction of operator risk and good opportunities for uniform dose distribution. Dr. Reddy’s Laboratories’ Anil Patni explained in depth both the equipment and best practices needed to develop and manufacture HPAPIs through lab scale to full drug product development.
Naturally, health & safety, along with containment and isolation, formed a large part of the discussion around HPAPIs. Justin Mason-Home from HPAPI Project Services emphasised the severity and unfamiliarity of the risks that potent drugs can pose to operators and manufacturers, and explained what kind of practices could be put into place to minimise those risks. His key principles were to remove any reliance on ‘gut feeling’, when it comes to safety, and instead design from a systematic, scientific perspective, using as much data as possible and introduce barrier containment.
ChargePoint Technology’s Michael Avraam and FPS Food Pharma Systems’ Stefano Butti spoke about containment systems for HPAPI processing requirements. They both emphasised the requirement for robust testing and standardisation of isolation and containment solutions, to ensure safety across manufacturing processes.
Finally, Youchu Wang of STA Pharmaceuticals gave a comprehensive overview of the HPAPI drug market, and provided a detailed case study of how the company had safely and effectively processed these highly potent compounds into ADC payload/linkers at its own facility, providing some real world context to the topics discussed over the course of the day.
Dr Thurloch O’criodain provided an inside look into a current hot topic in pharmaceutical production: nitrosamine contamination. As a key figure in the investigation of these contaminations with manufacturers throughout the last two years, Dr O’criodain is well placed to explain how they have arisen and what manufacturers have been able to do to reduce the risk. Specifically, he referenced improvements to reagent specifications, increased controls on use of recovered solvent, and improved analytical techniques for the detection of nitrosamines, among other methodology improvements.
Micropore’s David Palmer spoke about how the university spin-out has recently worked on scaling up its membrane emulsification process. The method, using stainless steel membranes with precision laser drilled pores, produces emulsions with significantly reduced droplet size variation. Initially, the company was only able to create small batches, and while this was useful on an academic basis, Palmer said, industry partners expressed a need for much larger quantities. Micropore’s presentation delved into the development of industrial scale devices for the production of over 1000 kg of emulsion per hour, with a footprint of less than an A4 sheet of paper.
Dr Rajeez Dattani of Freeman Technology gave an insightful presentation on the use of wet granulation to improve the behaviour of powders in manufacturing processes. He noted that powders can have extremely variable flow qualities depending on their aeration among other factors. Through granulation, he explained however, granules of specific BFE (basic flowability energy) can be created, allowing manufacturers to assure the quality of the final product.
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