Regulatory Affairs’ Role in Product Development

Analyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.

Meeta B. Kratz (Global Vice President, Product Management & Marketing, Lonza Capsule and Health Ingredients) talks about Lonza's future and how that works in tandem to meet client needs.

A case study in converting a solution formulation of a protein into an oral solid dosage form utilizing a fluid bed granulation process and some of the complexities involved.

The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.

Drive growth by establishing integrated, AI-fueled lab systems and a data-driven corporate culture that’s ready and resilient, no matter what business challenges emerge tomorrow. Evolving to a Lab of the Future takes the right technologies, systems, and expert guidance.

Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy discusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.