Newsletter | October 28, 2025

10.28.25 -- FDA Cracks Down On GLP-1 Imports

SPONSOR

Webinar: Achieving Pharma 4.0 with Next Generation Software-Defined Manufacturing and OEE Insights

Discover how Honeywell Aptica and TrackWise Manufacturing OEE are reshaping life sciences production. Gain real-time visibility, predictive insights, and automation to boost OEE by 20–25%, accelerate batch releases, reduce downtime, and ensure compliance. Join this impactful and informative webinar to see how software-defined manufacturing can make your operations more agile, scalable, and future-ready. Click here to learn more.

INDUSTRY INSIGHTS

Vision Inspection Software: The Missing Link In Digital Transformation

AI and MES can’t meet pharma’s visual inspection demands. Discover how purpose-built software ensures defect detection, compliance, and paperless quality for safer, more efficient operations.

How Digital Procedures And E-Logbooks Are Transforming Manufacturing

Paper-based processes slow down life sciences manufacturing and introduce compliance risks. Uncover how digital procedures and electronic logbooks can boost accuracy, speed, and traceability.

Agile Sterile Injectable Filling For Faster Market Entry

CMOs specializing in sterile injectable filling help pharmaceutical companies speed up development and commercialization through flexible manufacturing, adaptability, and strong collaboration.

FEATURED EDITORIAL

FDA Cracks Down On GLP-1 Imports

GLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.

INDUSTRY INSIGHTS CONTINUED

Diagnose Absorption Risks To Improve Preclinical And Clinical Outcomes

Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.

Seal Replacement As A Cost Avoidance Strategy

Proactive seal replacement in biopharmaceutical manufacturing prevents costly failures and downtime, ensuring product quality and process integrity.

Using Advanced Technologies To Formulate Complex Molecules

In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

The Story Of API-In-Capsule Technology And Its Future

Find out how advanced API-in-capsule technology addresses previous limitations, providing a flexible and efficient path for drug candidates from development to clinical trials.

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.

Intensifying Downstream Bioprocessing With Continuous Technologies

Watch to learn more about intensified downstream bioprocessing in-depth and take the first step toward a more innovative and efficient future in bioprocessing.

What Your Environmental Monitoring Isn't Telling You

Examine overlooked contamination sources, like residues, poor housekeeping, and training gaps, which offer practical strategies to strengthen your contamination control program.

Soluble Versus Insoluble Expression In Microbial Fermentation

Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?

Contrast In Oligonucleotides

Review the differences between research-use-only oligonucleotides and those manufactured in compliance with GMP 21 CFR 820.

Wrap-Around Labeler Ideal For Small Vials, Cartridges And Syringes

Delve into a reliable solution for labeling small batches of medical products, including vials, syringes, and cartridges, that fully automatic machines struggle to handle.

Clinical Phase Manufacturing With A Self-Contained Cleanroom Facility

Gain insight into the development of a mobile Biosafety Level 2+ (BSL-2+) facility adhering to cGMP for early-phase clinical trial manufacturing.

SPONSOR

Webinar: Choosing the Right Sporicide - Critical Factors for Robust Cleanroom Contamination Control

Join Professor Tim Sandle, PhD, and Ecolab Life Sciences for an in-depth look at key factors that influence the selection and optimization of sporicides in cleanroom environments. This webinar explores formulation, efficacy, safety, and practical considerations to help facilities choose and implement the most effective sporicidal agents for robust contamination control and improved cleaning performance. Click here to learn more.

SOLUTIONS

Clean In Place Detergent For The Life Sciences Industry

Efficient Process Lifecycle Management For Optimized Drug Development

Sophisticated 360° Inspection Of Round Containers

The Power Of DataOps In Unlocking AI For Pharma 4.0

Fill/Finish Capacity Update

Drug-Drug Interaction (DDI) Studies

Connect With Pharmaceutical Online: