Newsletter | September 29, 2025

09.29.25 -- Expanding Therapeutic Targets For Injection And Inhalation

SPONSOR

Discover available CDMO capacity for critical fill/finish services, including sterile filling, lyophilization, and advanced packaging, at the Fill/Finish session of the Outsourced Pharma Capacity Update (Oct. 10). This virtual event highlights technologies and quality standards essential for safe, effective biopharmaceutical delivery. Engage in short, interactive presentations and connect with CDMOs ready to support your manufacturing needs. Open to biopharma companies, consultants, and investors seeking trusted partners for late-stage production. Save your spot today!

FEATURED EDITORIAL

Expanding Therapeutic Targets For Injection And Inhalation

Chief Scientific Officer Geraldine Venthoye from Phillips Medisize joins Supplier Horizons host Tom von Gunden in a conversation about advancements in inhalation and injection for targeting a broader range of patient needs. The two discuss formulation and delivery system challenges for complex, large molecule biologics, including vaccines, immunotherapies, and cell and gene therapies.

FDA URRA Guidance: Use-Related Risk Analysis In Device Development

The FDA draft guidance on Use-Related Risk Analysis (URRA) clarified key considerations regarding the identification and mitigation of potential hazards in biopharmaceutical product use. In this article, Fran DeGrazio comments on the guidance.

INDUSTRY INSIGHTS

From Scale-Up To Scale-Out In Genetic Medicine Production

The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

De-Risking The Transition From Vial To Drug-Device Combination Product

When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

Rapid Developability Assessment Of Early Phase Molecules

A case study illustrating how to use PBPK modeling, the developability classification system, and the biopharmaceutics drug distribution classification system to facilitate development of a molecule.

Cell Therapy Development: An Innovator's Evolution To CDMO

Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

Solving The Silicone Challenge In Pre-Fillable Syringes

Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

SPONSOR

Join over 1,000 pharma, biotech and drug delivery experts at the 15th Annual PODD: Partnership Opportunities in Drug Delivery Conference, October 27–28, 2025, in Boston, MA. Featuring 10 focused tech tracks and a partnering app for 1:1 meetings, you’ll assess delivery needs, explore partnership opportunities and stay at the forefront of cutting-edge delivery solutions. Use code DDL20 for a 20% discount off registration.

SOLUTIONS

Pharmaceutical Development Tailored For Nanoparticle Formulations

Fill-Finish Capacity Expansion

Oral Solid Dosage Technology