Newsletter | May 21, 2025

05.21.25 -- Lilly's CEO Building On The Trump Agenda

SPONSOR

Webinar: A New Look at Subcutaneous mAb Delivery Using Nanoformed Particles

Subcutaneous (Sub-Q) delivery offers self-administration and fewer hospital visits but is challenging for high-dose biologics. Nanoform developed a concentrated, non-aqueous Sub-Q IgG1 suspension using its patented dry particle platform. The study evaluated particle size impact, formulation properties, protein quality, and stability, with pharmacokinetic studies ongoing. Key topics include Sub-Q benefits, Nanoform’s dry particle process, and non-aqueous suspension formulation. Click here to learn more.

INDUSTRY INSIGHTS

Work With An In-Country Depot For Efficiency And Compliance

If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.

Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

Aligning Pediatric Patient Needs With Drug Development Success

Executive Director of Pharmaceutical Sciences Srinivasan Shanmugam, Ph.D., discusses pediatric patient compliance, regulations impacting trial access, excipients within formulations, and more.

FEATURED EDITORIAL

Lilly's CEO Building On The Trump Agenda

“We hadn’t built a new site in the U.S. in more than 40 years until the first set of Trump tax cuts, so we need to see those either extended or improved to support this,” Eli Lilly CEO David Ricks recently said, announcing — in Washington, DC — plans to invest $27 billion to build four new manufacturing plants in the U.S.

April 2025 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report”. The report identifies CDMOs possibly impacted by events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

INDUSTRY INSIGHTS CONTINUED

Spray Dried Dispersions: Performance, Manufacturability, Stability

Explore advanced approaches to designing robust amorphous formulations and optimizing spray drying processes tailored specifically to difficult-to-formulate compounds.

The Regulatory Edge Of New Zealand For Pharmaceutical Development

By leveraging the country's regulatory advantages and partnering with a New Zealand-based CDMO, international companies can accelerate approvals and navigate the regulatory pathway with ease.

Formulation Of Crystalline Nanoparticles Enabling Superior Drug Load

Uncover how bioavailability of poorly soluble APIs can be improved and patient compliance enhanced by reducing the size or number of tablets that a patient must take to achieve the required dose.

SOLUTIONS

Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs

Review our full range of support services to streamline manufacturing processes through to the commercialization of aseptic and lyophilized products.

Formulation And Manufacturing Equipment

Consider our integrated GMP manufacturing services for oral dosage forms with a full complement of analytical development and testing capabilities for your next project.

Streamline Your Preclinical Manufacturing In India

Discover cost-efficient, global solutions for process development and preclinical manufacturing — partner with a trusted network to simplify your outsourcing 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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