Newsletter | August 15, 2025

08.15.25 -- Environmental Monitoring Performance Qualification In Manufacturing Facilities

SPONSOR

Webinar: Extractables, Leachables, and Risk: Ensuring Safety in Pharma Manufacturing

Join this expert-led Pace webinar to gain a clear, step-by-step strategy for managing extractables and leachables (E&L) risk. Discover how to assess materials, assign risk scores, and reduce testing burdens—all while staying aligned with USP requirements. Whether you're launching new products or prepping for regulatory submissions, this session will streamline your approach. Secure your spot today! Click here to learn more.

INDUSTRY INSIGHTS

Nuances Of Sample Preparation For Stability Programs

Review why, in early-phase drug development, precise sample preparation for UHPLC testing is crucial to ensure accurate and reliable stability data.

The Powerful Combination Of Spray Drying And Nanomilling

Discover an integrated approach that reduces particle size, enhances stability, and transforms nanosuspensions into scalable solid forms—boosting dissolution, bioavailability, and therapeutic success.

Control Strategies And Method Development For Nitrosamines

Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

FEATURED EDITORIAL

Environmental Monitoring Performance Qualification In Manufacturing Facilities

In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

The Mighty CDMOs Producing API

CDMO focused on active pharmaceutical ingredients (APIs) have long been vital components in the supply chain. Today, they are more than your enablers. CDMO have become strategic actors helping to reshape global outsourcing markets. A new report focuses on the new forces raising their importance.

INDUSTRY INSIGHTS CONTINUED

Common Tablet Defects And The Importance Of Blending

Learn to minimize tablet defects like picking, sticking, and capping, as well as common issues and the critical role of blending in achieving quality tablets.

Highly Potent API Drug Product Development Using Micronization Technology

As demand grows, the need for advanced safety measures and reliable manufacturing technologies becomes critical, making it essential to partner with an experienced HPAPI manufacturer.

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Join Outsourced Pharma Online on September 3rd at 2pm ET for a virtual panel discussion on overcoming difficulties outsourcing development and manufacturing, how does a biopharma organization (of any size) handle a multi-CDMO coordination. Registration is free for this digital event.

SOLUTIONS

Choosing A CDMO For Oral Solids, Nasal And Pulmonary Dosage Forms

Gain insight into the many advantages of partnering with a CDMO, including extensive expertise and capabilities across oral solids and specialized nasal and pulmonary formulations.

Your Molecule. Our Mission.

Our scientists excel at building connections. Start a conversation today and witness the benefits of collaborating with a CDMO.

Solid Form Services

Witness how we defined workflows to assess and select solid forms in a cost and time-efficient manner that meets the needs of each individual program.

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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