Insights On CONTRACT PHARMA MANUFACTURING

1. Spray-Dried Dispersions For Complex Drug Products 9/22/2026

   Poor solubility can stand between a promising molecule and its potential. Discover how spray-dried dispersions can help move challenging compounds forward.

2. Rethinking 'Platforms' In Cell And Gene Therapy Development 9/21/2026

   Standard platform processes promise speed and consistency in CGT development, but biological variability and evolving program needs often expose their limitations.

3. Beyond The Starting Material: A Path To GMP Manufacturing Success 9/21/2026

   Explore how starting material decisions affect cell therapy development, tech transfer, and GMP readiness, as well as practical guidance for aligning material requirements with manufacturing processes.

4. Addressing Plasmid DNA Challenges In Large-Scale AAV And Lentivirus Manufacturing Using dbDNA 9/21/2026

   Plasmid DNA supply and regulatory concerns constrain large-scale viral vector manufacturing. Here, we examine whether enzymatically generated dbDNA can deliver comparable rAAV and rLV production outcomes.

5. Coordinated Drug Development As An Execution Framework 9/21/2026

   When clinical research, CMC, manufacturing, and supply operate in silos, every phase transition resets alignment. Here, authors examine what changes when those functions operate within a shared execution framework.

6. Quality As A Strategic Differentiator In Drug Development 9/21/2026

   When quality functions as an operational discipline rather than a downstream control, it stabilizes complex drug development programs rather than slowing them down. This paper examines what that requires in practice.

7. Guidelines For Structuring A First-In-Human Clinical Trial Application Dossier 9/21/2026

   Preparing a first-in-human clinical trial application dossier involves navigating real uncertainty about how much CMC detail regulators expect at this early stage.

8. Catalent Capabilities Update September 2026: ADC 9/21/2026

   Discover how a single, consistent analytical partner can simplify your path to IND and BLA — no matter where you manufacture.

9. Lonza Capabilities Update September 2026: ADC 9/18/2026

   Iwan Bertholjotti, Sr. Director of Commercial Development for Bioconjugates, discusses how Lonza's capabilities meet the growing demand for seamless progression from clinical development to commercial manufacturing.

10. Turning Rapid Study Start-Up Into Enrollment Momentum 9/18/2026

    A large Phase III ATTR-CM outcomes trial spanning 37 countries reached 50% enrollment eight months early, with monthly accrual rates running 3–5x above plan through coordinated cross-functional execution.