06.21.23 -- Manufacturing To The Highest Standards Of Product Quality And Regulatory Compliance

Changes to the equipment and processes used to produce a semi-solid dosage form may affect physicochemical characteristics, bioavailability, and sensory qualities. The right CDMO should provide the expertise and technology needed to perform the formulation, engineering, analytical testing, and validation work critical for successful site transfer.

A company was seeking a CDMO partner with the expertise and technological capabilities to combine three drug substances into a fixed-dose combination product suitable for adult and pediatric dosing. Working with a flexible outsourcing partner with a broad range of capabilities and advanced know-how helped provide an advantage.

Establishing a relationship with a partner who has the right equipment, scientific expertise, and project management skills is crucial to mitigating risk in tech transfers — and ultimately controlling costs. Gain key insights into how best to mitigate risk in tech transfer, including how to find the best partner.

Topical products, whether prescription dermatological drugs or over-the-counter lotions, creams, or gels, present unique challenges in terms of development and manufacturing. When faced with the many challenges of producing a safe, cost-effective, high-quality topical product, many companies will seek the expertise and experience of a CDMO partner.