Newsletter | October 24, 2025

10.24.25 -- Trust But Verify: Validating AI In Pharma's GxP World

SPONSOR

Webinar: Advancing Topical Formulations with Innovative Preclinical Models

In this webinar, experts will explore strategies to improve drug candidate success rates by integrating robust formulation development and predictive preclinical models. Learn how comprehensive drug characterization, in vitro/ex vivo testing, and systematic formulation approaches can identify promising candidates early, reduce development risks, and align with evolving regulatory expectations to streamline development and improve overall therapeutic outcomes. 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.

Control API Impurities To Achieve Therapeutic Safety And Efficacy For Patients

In your CDMO search, prioritize finding a partner who recognizes impurity control as a critical component of patient-focused drug development and offers the necessary capabilities to ensure it.

Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation

Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.

FEATURED EDITORIAL

Trust But Verify: Validating AI In Pharma's GxP World

Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

Did Trump Just Create An Antibiotic Supply Chain In The US?

In 2022, we had headlines such as: FDA Declares Nationwide Amoxicillin Shortage. Now three years later, a homegrown manufacturer — USAntibiotics of Bristol, Tennessee — says it can cover America’s demand under a new arrangement with two titans of distribution and retail: McKesson and Walmart. The other “titan” in the deal is President Trump.

INDUSTRY INSIGHTS CONTINUED

Enabled Form Selection For Oral Drug Products

Watch as speakers delve into the intricacies of formulation maps for amorphous solid dispersions (ASDs) and the key criteria for salt screening, which are essential in early-phase screening for enabled forms.

Reshaping Drug Development With 3D Screen Printing

Steven Facer and Laxxon Medical COO Klaus Kühne describe the capabilities of 3D screen printing for pharmaceutical production. Explore prototyping, IP protection, release profile possibilities, and more.

Science Of Scale For Spray Dried Intermediates

Significant interest has been focused on the science of scale for spray drying. Gain insight into critical steps that can smooth the development pathway, eliminating scale-up headaches down the road.

SPONSOR

Join 1,000+ pharma, biotech, and drug delivery professionals at the PODD: Partnership Opportunities in Drug Delivery Conference, October 27–28 in Boston. Featuring 10 technology tracks, pharma company spotlights, 1:1 partnering, and more. Attendees will also hear from leaders at companies including AbbVie, Amgen, AstraZeneca, Biogen, Eli Lilly, GSK, Moderna, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and others. Register at PODDConference.com with code LSL20 for 20% off.

SOLUTIONS

Pharmaceutical Bottom Labeler

The HERMA 552C bottom labeler is a compact and versatile solution for applying labels to the underside of products, eliminating unnecessary work and minimizing setup times.

Boost Quality For More Efficient Tablet Manufacturing

Consider three new solutions that improve tablet quality, reduce setup time, and protect your equipment for more efficient tablet manufacturing — presented by a seasoned expert in tooling and tablets.

IND-Enabling Services For Highly Potent Molecules

From early-phase IND-enabling studies to late-stage development and full commercialization, we provide support tailored to the needs of emerging biotechs and established pharma companies.

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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