02.11.26 -- With CDMOs Like This, Who Needs Biotechs?

AI is shifting from experimentation to execution in drug development. This OPCU special edition explores where AI delivers value today—across discovery, CMC, and quality—and how CDMOs and sponsors can collaborate to reduce risk, improve quality, and accelerate timelines, with practical guidance on readiness, regulatory considerations, and sponsor expectations.

Leveraging early-stage collaborations and flexible delivery systems can help navigate complex regulatory landscapes while accelerating the delivery of safe, self-administered injectable therapies.

David Lyon, Ph.D., and Molly Adam answered questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.

Learn how to classify HPAPIs in early development and recommendations for safe product handling, from clinical manufacturing to commercialization.

Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.

A healthcare manufacturer facing space constraints and regulatory pressures outsourced their stability storage needs to another company, resulting in reduced costs and focus on core competencies.

Compliance with EU GMP Annex 1 requires a strategic CCS. Assimilating how a framework based on people, communication, process, and improvement enables systematic, long-term compliance.

Traditional drug models fail to predict performance in human skin. Advanced, multifactorial ex vivo disease models directly address inflammation and infection to de-risk formulation development.

Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.

Using AI tools for retrosynthesis can help you investigate molecules interactively to build a complex API manufacturing process that maintains your timeline and saves you money.

A 36,000-square-meter Zhunan, Taiwan facility delivers flexible, high-quality cGMP oral solid dose manufacturing with access to major markets including North America and the EU.

Uncover an analytical laboratory seamlessly integrated with manufacturing and packaging operations, which offers dependable chemical and microbiological testing that adheres to cGMP standards.

An integrated supply chain, with transparency among sponsors and suppliers, ensures that regulatory starting materials are well characterized and free of impurities that can impact the final drug product.

View fully trained onsite scientific teams that integrate seamlessly into manufacturing operations while ensuring compliance and operational agility.