Strategies For Successful Manufacturing Of Highly Potent Oral Solids

The global pharmaceutical market continues to be driven by the growing demand for oral drug products containing highly potent active pharmaceutical ingredients (HPAPIs). These powerful compounds offer significant therapeutic benefits, particularly in oncology and other targeted treatments, but their potency also presents unique challenges in drug development and manufacturing. From stringent containment requirements to specialized handling and processing techniques, the production of HPAPI drug products requires a high level of expertise, regulatory compliance, and advanced technological capabilities.

For pharmaceutical companies developing HPAPI-based therapies, selecting the right contract development and manufacturing organization (CDMO) is a critical decision. The complexity of HPAPI manufacturing necessitates a strategic partnership with a CDMO that has the infrastructure, experience, and regulatory knowledge to ensure both safety and efficiency. In this discussion, industry experts explore some of the key challenges in HPAPI drug product manufacturing and highlight essential factors sponsors should consider when evaluating a CDMO partner.

Featured Experts:

Anshul Gupte, Ph.D., RAC Drugs – Sr. Director, Scientific & Technical Affairs
Brad Gold, Ph.D. – Head of Product Development