OSD
Small, medium and large pharmaceutical companies are continuing to outsource oral solid dose (OSD) manufacturing to contract development and manufacturing organisations (CDMOs). The global OSD contract manufacturing market was estimated at $36.5 billion in 2023 and is forecast to grow at a compound annual growth rate of 5.97% until 20301.
Given this increasing demand, CDMOs must be well-equipped to successfully deliver on OSD projects and meet customer needs. This includes:
- Comprehensive analytical testing facilities:
Having advanced analytical testing capabilities ensures that products are safe and of high quality. For example, in light of the increasing number of regulations of medical device materials imposed by the U.S. Food and Drug Administration (FDA), it is critical to implement analytics that facilitate meticulous control over extraction, analysis and identification of extractables, leachables and impurities. - Robust tech transfers:
Professional and structured project management is at the core of tech transfers. A strategy must be in place to effectively assess risk and analyse materials, processes and equipment differences. Executed with scientific trial planning, an in-depth understanding of the design space and robust processes are obtained. - Guaranteed commercial supply:
An industry sales and operations planning (S&OP) process that is capacity-based and well established ensures that every order is actioned effectively and with certainty. Visibility across production lines also enables a flexible response to short-, mid- and long-term capacity issues. - Advanced technological approaches:
Harnessing in silico tools enhances drug manufacture. For example, in silico methods can help to evaluate the correlation between material properties, production processes and quality attributes or enable analysis of historical data in batch manufacturing to help with the understanding of critical parameters.
With these robust practices, facilities and processes in place, CDMOs can effectively and efficiently deliver on OSD projects.
Learn more about how Recipharm delivers on OSD projects by investing in analytics, supporting tech transfers and guaranteeing commercial supply from our Head of Product Development, Oral Solid Dose Dr Uwe Hanenberg who recently spoke with European Pharmaceutical Manufacturer.
References:
1. Oral Solid Dosage Contract Manufacturing Market Report 2030. Accessed 31 January 2024, from: https://www.grandviewresearch.com/industry-analysis/oral-solid-dosage-osd-contract-manufacturing-market-report