Newsletter | October 21, 2025

10.21.25 -- 10 Ways To Strengthen U.S. API: Part II

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

Dynamic Precision Weighing Challenges And Innovations

Effective precision weighing systems enable users to balance product throughput, center distance, and standard deviation. Explore key considerations in this technology's development and weighing methods.

Why The Latest E2500-25 Standard Revision Demands Immediate Action

The updated E2500-25 standard transforms pharmaceutical manufacturing with a proactive, risk-based approach, enhancing compliance and accelerating the delivery of therapies to patients.

Managing Supply For Complex Biotherapeutics

Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.

FROM THE EDITOR

10 Ways To Strengthen U.S. API: Part II

We continue the API supply chain conversation, jumping into KSM sourcing and substitution, utilizing idle space and connecting the dots. The road to strengthening the U.S. pharmaceutical supply chain won’t be easy, but it is manageable.

INDUSTRY INSIGHTS CONTINUED

Normalized Data In Microbial Continuous Monitoring

Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

The M.O. Behind Choosing A CDMO: Three Considerations

The greatest challenge in drug development can be finding a team capable of carrying a molecule through complexities. Discover three considerations that build a foundation for partnership.

How Oral GLP-1 Therapies Are Revolutionizing Obesity Treatment

The rising incidence and severity of obesity have amplified a therapeutic need in healthcare. Read more about Dr. Srinivasan Shanmugam discussing the challenges and impact of GLP-1 analogs.

Innovation In Filtration

Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Examine how its simplicity and reliability make it indispensable.

In Vivo Testing Of Nasal Dosage Forms

Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.

Rapid, Material-Sparing Feasibility Screening For Hot Melt Extrusion

Uncover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.

Using SEC For Reliable Biotherapeutic Peptide Analysis

Gain insight into a breakthrough in analytical performance that delivers unmatched precision, faster results, and reduced waste. This innovation sets a new standard for sustainable analysis.

Characterization Of Pharmaceutical Materials With Modulated DSC

Modulated DSC addresses challenges in material characterization, which enables precise analysis of glass transitions and overlapping transitions to enhance insights beyond standard DSC.

Providing Packing And Blinding Solutions For An Innovative Drug Start-Up

Find out how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

Partnering With Spokane College To Build A Certification Program

See how a partnership with SCC helped launch a biomanufacturing program to build career pathways and community talent for Spokane’s growing life sciences and pharmaceutical manufacturing sector.

SOLUTIONS

Cleanrooms For R&D And Testing Facilities

Learn More About Our Team

Minimize Risk With Interactive Logbooks

Bottling Solutions

Formulation And Analytical Tour

Connect With Pharmaceutical Online: