Newsletter | September 26, 2025

09.26.25 -- Hybrid. Continuous. Peptide. Manufacturing. Lilly's Put It All Together.

SPONSOR

Webinar: From First-in-Human to Proof-of-Concept — Quicker, Smarter, Streamlined

Unlock the keys to successful First-in-Human studies with Quotient. This webinar reveals how expert-designed SAD/MAD trials, flexible CMC strategies, and smart regulatory planning accelerate proof-of-concept while avoiding costly setbacks. Gain insider insights on biomarkers, patient recruitment, and data integration—plus real-world case studies across rare diseases, obesity, CNS, and inflammation. De-risk early development and keep your program moving forward. Click here to learn more.

INDUSTRY INSIGHTS

The Rise Of Complex OSD Generics: Understanding Development Challenges

Understanding the potential pitfalls and partnering with the right experts can make all the difference in overcoming the complexities of complex generic OSD development.

Developing Amorphous Solid Dispersions For Poorly Soluble Drugs

Discover how a strategic amorphous solid dispersion approach improved bioavailability and advanced a low-solubility compound toward clinical readiness in just four weeks.

Blending And Simulation: A Beginner's Guide

This beginner-friendly webinar reveals essential steps to understand mixing, reduce segregation, enhance efficiency, and improve product quality with granular materials.

FEATURED EDITORIAL

Hybrid. Continuous. Peptide. Manufacturing. Lilly's Put It All Together.

After reading part one with Lilly Kinsdale's Lorraine O'Shea, readers want to learn more about that facility’s “hybrid continuous manufacturing for peptides” technology. Chief Editor Louis Garguilo explores that technology with O'Shea, and ties it into thoughts of CDMO facilities as well.

Building Manufacturing Facilities Of The Future Require A Phased IT/OT Strategy

Your pharma or biotech company can take these actionable steps to achieve digital facility operations and successfully build your own facility of the future. 

INDUSTRY INSIGHTS CONTINUED

De-Risking Early Phase Micronization With Integrated Solid Form Selection

Review a case study describing the selection of the optimal solid form of an API designed for pulmonary administration through the pulmonary route.

2025 And Beyond: Another Look At Upcoming NDSRI Regulations

The presence of nitrosamine drug substance-related impurities (NDSRIs) in medications has become an urgent issue for the pharmaceutical industry. Understand the acceptable intake (AI) limits.

6 Benefits A Biotech Should Expect From Their CDMO Program Team

Whether a biotech is emerging or established, a dedicated CDMO program team offers invaluable support through communication, technical and regulatory guidance, and adaptability to change.

The Development And Manufacture Of Drugs With HPAPIs

Learn why companies must invest in specialized expertise to develop scalable, safe, and efficient manufacturing processes for highly potent oral solid dose products.

Creating A Project Management Office (PMO) At A Small Manufacturing Site

See how the implementation of a Project Management Office transformed a small manufacturing site into a high-performing, strategic asset within a global network.

SOLUTIONS

A QMS That Helps You Transform Compliance Into A Competitive Advantage

Turn compliance into a competitive advantage with this five-module QMS system that works to give teams a holistic view of quality and tear down siloes between departments.

Medicinal Chemistry Expertise In India

Experience an innovative business model, complete with a network of medicinal chemistry capabilities, that does not add additional costs to your project.

Lab Equipment And Testing Site Matrix

Our analytical and testing services are available as standalone offerings or as complementary support to drug substance and product development and manufacturing, tailored to your program needs.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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