Newsletter | December 19, 2025

12.19.25 -- 2025 GLP-1 Impacts Tell Us About CDMOs In 2026

INDUSTRY INSIGHTS

OSD Early Stage: Getting Oral Products Into Clinic Early

Strategic formulation choices and early solubility screening are vital for overcoming poor solubility and limited supply to accelerate the path to first-in-human trials and stand up to the pressure.

API In Capsule Vs. The Lost Art Of Formulation Development

API-in-capsule offers a fast path for early clinical data, but it can't eliminate the need for full formulation development. Weighing the potential for higher total development time and cost is critical.

Ensuring The Compliant Manufacture Of Highly Potent Drug Products

Explore the complexities of producing highly potent APIs and related drug products while ensuring full GMP compliance. Case study included.

FEATURED EDITORIAL

2025 GLP-1 Impacts Tell Us About CDMOs In 2026

When we began covering the nexus between GLP-1 drugs and CDMO capacity, there were two key questions: Could Big Pharma keep up with demand? Would the CDMO market also have capacity to serve the thousands of drug sponsors needing assistance with their non-GLP-1 programs? Those answers in 2025 tell us a lot about our industry heading into 2026.

Ensuring Quality And Regulatory Compliance In Outsourced Manufacturing

This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” outlines how sponsors can ensure that a CDMO’s quality systems and analytical outputs meet regulatory expectations by aligning early on target regions, building audit and qualification rights into contracts, executing robust quality agreements, monitoring QMS metrics, and overseeing third-party testing vendors.

INDUSTRY INSIGHTS CONTINUED

Mitigating Powder Flow And Static Issues Using Mesoporous Silica

See how incorporating small amounts of SYLOID® 244 FP during micronization can significantly enhance powder flow, thereby making subsequent blending and formulation more efficient.

Control Strategy And Minimizing Risk In Phase 1 Injectable Drug Development

A well-crafted strategy isn’t just about defense. Investing early in the right controls not only minimizes risks but also accelerates timelines, streamlines regulatory interactions, and builds trust.

Designing Shelf-Stable, Dry Powder Vaccines To Improve Global Access

Spray dry technology is being leveraged to create shelf-stable, dry-powder vaccines to treat and prevent the spread of tuberculosis which could significantly improve our global response to disease.

Strategies For De-Risking Early-Phase Oral Small Molecule Drug Development

A team of experts discuss risk-reduction strategies, critical formulation considerations, and careful technology selection to stretch the often limited quantities of API available for early studies.

End-To-End Development And Manufacturing: Small Volume Commercial Products

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

A Smarter Strategy For Optimizing Oncology Drug Products

VP of Scientific Consulting John McDermott shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate optimization.

3D Screen Printing: Breakthrough Solutions For Patient-Centric Therapies

Review this 3D screen printing’s potential to revolutionize pharmaceutical manufacturing with scalable, customizable, multi-drug tablets and precise, patient-centric drug release profiles.

SOLUTIONS

Drug Product Development Of Poorly Soluble Compounds

We offer comprehensive drug product development and manufacturing, specializing in poorly soluble compounds, clinical manufacturing, and integrated solutions for diverse clients.

Capabilities Update October 2025: Small Molecule

For clinical trials, we provide full support from warehousing to returns. Join Ropack's Head of Commercial, Chris Vounasis, for a presentation on our technologies and 2025–2026 capacity.

Accelerate NCE Discovery With India-Based Medicinal Chemistry Expertise

Consider utilizing our cost-efficient global network and connecting with our team today to streamline your medicinal chemistry and outsourcing needs.

Capabilities Update October 2025: Small Molecule

Get an overview of our AI-assisted early phase toolkit, which combines predictive modeling, formulation screening, and data-driven insights to accelerate molecule progression.

Accelerate Innovation With Compliant Software Solutions

Speed up your innovation with software solutions that are designed to streamline operations, reduce costs, and speed time-to-market while ensuring compliance and data integrity.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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