June 20th: Meet us at BOS Basel 24
APC & VLE Therapeutics is looking forward to seeing you June 20th, 2024 in Basel!
Stop by and say hello at booth no. 17!
If you're planning on attending, we’d love to meet one-on-one to discuss your development and manufacturing challenges and our approach to accelerating your medicines through CMC hurdles.
Meet us in the exhibition area or schedule a meeting to discuss your project!
Technical Presentations
When: June 20th, 2024, 10:45 - 11:00
Presented by: Brendan Roche PhD, Senior Process Development Engineer, APC
Presentation Title: Enabling Robust Impurity Rejection and Form Control in the Crystallization of a Small Molecule API by Switching from Batch to Continuous Processing
Within the past decade the pharmaceutical industry has embraced the implementation of continuous processing as part of a concerted effort to modernize the methods by which therapeutic products are developed and manufactured (Burcham et al., 2018). In the production of small molecule active pharmaceutical ingredients (APIs), numerous product quality, safety, sustainability, and cost benefits can be realized by parting ways with antiquated batch processing methods and focusing new synthetic routes towards continuous processing infrastructure.
In this presentation, APC discusses the opportunity landscape for continuous processing in API crystallization and how continuous crystallizers can be used to enable robust control of critical quality attributes (CQAs) (e.g., crystal purity, form, and size) that can be difficult to consistently deliver through a batch operation, particularly as production volumes scale with progression through clinical development. These advantages are further explored through a case study on an industrial crystallization process to isolate a Janus kinase 1 (JAK1) inhibitor, where the purging of a key impurity had become challenging in the batch production-scale process and an alternative continuous crystallization process was developed to improve the robustness of the impurity rejection (Morris et al., 2022).
Meet our technical expert at our booth no.17 or schedule a meeting!
Abhishek Mysore Srikant is a Senior Process Development Engineer within the Small Molecule Engineering Function at APC Ltd. He has over 10 years of industrial experience in API process development and tech transfer. His specialist technical expertise is in crystallization process development, crystal form/salt screening, particle engineering, scale-up, and milling, filtration, and drying unit operation design.
Announcing The Medicine Accelerator Campus
Explore our 130,000 sq ft campus in development, the largest R&D site in the biopharma sector in Ireland and the expanded home for APC & VLE, will integrate the latest developments in scientific research, AI, neural networks and scientifically led manufacturing activities. This value chain is transforming medicine development and the time to patient for new and advanced therapeutics.