OSD
In 2023, the pharmaceutical industry can expect to see a significant rise in the development of oral biologics.
Biologics are traditionally administered via injection due to issues with absorption, and the sensitivity of the active ingredients to degradation in the gastrointestinal tract, which poses a level of discomfort to patients. However, recent advancements in oral solid dose (OSD) technology have made it possible for some biologics, such as insulin, to be developed for oral administration, offering patients the convenience of taking their medication in pill form.
However, drug developers still face significant challenges when formulating oral biologic treatments. Support from OSD formulation experts will be crucial in 2023 to help biotechs overcome these barriers to development.
Another trend impacting the OSD space is the growing demand for small-batch manufacturing to support the orphan drug market. These rare diseases affect a small number of people worldwide, meaning that only small volumes of drug product are required. New commercial paradigms and manufacturing processes are essential to help ensure that these medicines are financially viable.
3D printing of OSD forms is increasingly being considered for cost-effective small-batch drug product manufacturing. Offering more significant levels of flexibility and versatility, this technology is capable of manufacturing various treatments in small quantities with minimal changeover downtime. 3D printing also enables companies to manufacture individual tablets with intricate internal structures to achieve precision-controlled release profiles.
As a result, we can expect to see a growing demand for contract manufacturing partners with 3D printing capabilities in 2023 and beyond.
Artificial intelligence is also expected to play a role in drug development in the OSD space over the next year. Machine learning, for example, can improve data analysis during discovery and development, increasing the chances of OSD project success.
In a recent roundtable discussion with Drug Development & Delivery, Uwe Hanenburg, our Head of Product Development for Oral Solid Dose, joined other industry leaders to share his thoughts on the recent biologics trends in the OSD space, and how they are set to impact drug development in 2023 and beyond.