02.13.26 -- The Industrialization Of Advanced Modalities

Developing semi-solid topical drug products from concept to commercialization presents unique formulation and scale-up challenges. This webinar explores how excipient interactions, processing parameters, and equipment differences impact stability, performance, and patient experience. Learn how applying Quality by Design (QbD) principles across development, scale-up, and manufacturing reduces risk and supports reliable, commercially viable products from bench to market success. Click here to learn more.

Improve medication adherence and health outcomes by developing patient-friendly dosage forms that enhance swallowability and palatability for pediatric, geriatric, and dysphagic populations.

See how streamlined early-phase strategies, smarter trial design, and data-driven decisions can accelerate progress from first-in-human studies to proof-of-concept.

Understand how softgel technology enhances rapid drug absorption and precise dosing, offering crucial benefits for high-potency oncology treatments.

Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.

Learn how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

Closing and following up after a CDMO audit requires organized findings, communication, recommendations, and ongoing collaboration to strengthen compliance and build partnership success.

Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

We discuss three enabling technologies designed to improve drug solubility in organic solvents for spray drying and define the advantages and risks of each technology.

Reveal essential steps to understand mixing, reduce segregation, enhance efficiency, and improve product quality with granular materials.

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.

Leverage scalable hybrid SPPS/LPPS manufacturing strategies and deep small-molecule expertise to efficiently advance peptide programs from development through multi-ton commercial production.

Secure your supply chain with a trusted partner in sterile manufacturing. Uncover a dual-site strategy that offers redundancy, high regulatory confidence, and a proven approach to efficient tech transfer.

A risk-based shift streamlines software validation by reducing non-value activities, emphasizing critical thinking, and focusing testing on functions that most impact safety, quality, and system integrity.

High Potent APIs (HPAPIs) require advanced consideration for development and manufacturing, including highly regimented protocols and specialized facilities to ensure safety.