Newsletter | November 7, 2025

11.07.25 -- Roll Call In The Oral GLP-1 Race

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Take a brief tour of Nanoform's advanced nanoformulation, nanoanalytical, and best-in-class capabilities. This video highlights Nanoform’s advanced characterization tools, state-of-the-art formulation technologies, and expert-driven solutions designed to tackle bioavailability challenges. Watch the video now.

INDUSTRY INSIGHTS

Effective Environmental Monitoring And Control In Pharma Operations

A structured contamination control strategy uses the Plan, Do, Study, Act model, focusing on EMPQ, meticulous planning, trend analysis, and continuous improvement with CAPA and change control.

From Molecule To Market: Understanding The Roles Of CROs, CMOs, CDMOs

Understand the distinct roles of CROs, CMOs, and CDMOs in the journey from molecule to market. Choosing the right partner for your drug development stage is critical for success.

Rethinking MES In Pharma: Faster Reviews, Better Data, Less Risk

Discover how composable MES helps pharma teams scale faster, enforce SOPs, and maintain data integrity while empowering frontline teams to build workflows that fit their operations.

FROM THE EDITOR

Roll Call In The Oral GLP-1 Race

The market for GLP-1 agonists is booming and expected to only get bigger. As rates for obesity and cardiovascular disease increase, so too does the demand for GLP-1 drugs.

INDUSTRY INSIGHTS CONTINUED

Robotics And Automation Addressing Production Shortages

Drug shortages have increased the burden on compounding pharmacies. Robotics and automation can streamline processes, improve accuracy, and ensure quality to address these challenges.

Understanding And Mitigating Oxygen Heterogeneity In Bioreactors

Oxygen heterogeneity, caused by pressure variations and other factors in large-scale bioreactors, can significantly impact cell growth and product yield.

Automated Active Microbial Collection In Aseptic Filling Lines

Learn how automated environmental monitoring strengthens contamination control strategies, reduces risk, and supports intervention planning in aseptic filling lines.

Ensuring The Efficacy Of Probiotic Products

Without proper handling and packaging, the efficacy of probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and effectiveness.

Demolishing Doubts About AI In Pharma

The FDA and PDA's recent initiatives provide frameworks and guidance for integrating AI into pharmaceutical manufacturing, emphasizing innovation, and safety.

Optimizing CMO Partnerships

SMC experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

Strategies To Enhance Efficiency In mAb Bioprocess Development

Advanced computational methods coupled with bioinformatics can be used to navigate the complexities of bioprocessing by anticipating challenges before they arise.

Key Factors In Selecting Your Ideal Microbial Air Sampler

Find out how to evaluate microbial air samplers based on collection efficiency and flow rate accuracy, as well as key factors that support data integrity and compliance in environmental monitoring programs.

Selecting Sporicidal Disinfectants: What Cleanroom Managers Need To Know

This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

Thermal Stability Technology Selection Guide

Thermal stability testing is essential for biologics development to help ensure safety and efficacy. Explore how thermal data supports candidate selection, formulation, and storage decisions.

Driving Innovation In Decentralized Manufacturing

Unlock the potential of localized manufacturing and uncover how cutting-edge technology is transforming access to essential medications, ensuring patients get what they need.

Mitigating Powder Flow And Static Issues Using Mesoporous Silica

See how incorporating small amounts of mesoporous silica during micronization can significantly enhance powder flow, thereby making subsequent blending and formulation more efficient.

De-Risking A Bioconjugate's Development Path From Discovery To Clinic

Understanding the obstacles you may face during bioconjugate development, as well as the tools available to help overcome them, can help streamline your product’s path to market.

Looking To Maximize Efficiencies During Process Development?

Maintain consistent yields and quality at large volumes. Examine how single-use bioreactors ensure seamless process development to production with consistent yields and quality.

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Webinar: Resolutions to Results: Cleanroom Changes in 2026 for Better Contamination Control

As 2026 approaches, Contec's "Cleanroom Resolutions" webinar invites contamination control professionals to reflect, refocus, and refine their strategies. Drawing on insights from over 450 submissions, experts will explore emerging trends, environmental monitoring, and the impact of human factors on cleanroom performance. Attendees will gain actionable, data-driven approaches to residue management and continuous improvement for stronger contamination control programs. Click here to learn more.

SOLUTIONS

Enhance Your Workflow With A High-Speed Centrifuge System

Combination Metal Detection And Weight Control System

The Leader In Pharmaceutical, Process, And Packaging Equipment

Solving Complex Formulation Challenges From Coast To Coast

Our Biotech Success — Levicept

Lab-Scale Aseptic Filling System For Cell And Gene Therapy

Scientist Spotlight: TJ Harper

Compliance Program For EU Annex 1 Container Closure Requirements

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Don't miss the 2025 ISPE Pharma 4.0™ Conference, taking place 9–10 December in Barcelona, Spain, and virtually. Uncover best practices in AI/ML model development, how to align initiatives with regulatory expectations, and how to mitigate risks along the way. Gain insights from real-world case studies and explore frameworks guided by ISPE GAMP® resources, including the new ISPE GAMP® Guide: Artificial Intelligence.

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