Newsletter | June 23, 2026

06.23.26 -- Managing Organic Impurities And Nitrosamines In APIs

SPONSOR

Webinar: False Rejects Aren’t Inevitable: How to Reduce Waste and Improve Line Efficiency

False rejects can drain yield, slow production, and undermine confidence in inspection systems. In this Thermo Fisher webinar, experts will break down the causes of false rejects and share practical strategies to improve stability, reduce variability, and strengthen production performance. Attendees will also receive an actionable checklist to support consistent throughput, compliance, and product quality across operations. Click here to learn more.

INDUSTRY INSIGHTS

Optimizing The Path From First-In-Human To Proof-Of-Concept

By collapsing the gaps between manufacturing and clinical trials and integrating these functions into a unified system, teams can adjust formulations in real-time and accelerate timelines.

Solving The Inhalation Puzzle: A CDMO's Guide To Dry Powder Development

Gain guidance on the choice of formulation, excipients, and the micronization technologies offered by CDMOs, and learn about current encapsulation technologies for inhaled products.

LYO Cycle Development Ensures Success For Oncology Drug Scale-Up

An optimized lyophilization cycle removes excess moisture during scale‑up by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.

FEATURED EDITORIAL

Managing Organic Impurities And Nitrosamines In APIs

How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

INDUSTRY INSIGHTS CONTINUED

Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1?

EU GMP Annex 1 is driving meaningful changes in how teams behave. Understand what contamination awareness really means in practice and how to build a culture where speaking up is standard.

A Practical Guide To Checkweighing And Checkweighers

Nothing saves money like a checkweigher. A checkweigher weighs every product in motion to help you meet throughput and legal requirements. Delve into the technology and options for your application.

Biopharmaceutical Packaging Solution Advancements And Considerations

Explore how to develop a strong packaging system, and learn more about why a reliable supply chain is critical for drug substance and drug product transport.

5 Minutes With: Jeff Goldman, General Manager

A look at the motivations, challenges, and vision shaping a new approach to life science tools—focused on practical design, thoughtful engineering, and expanding access to technologies.

Scaling Clinical To Commercial With One CDMO

Assessing whether to stay or switch CDMOs means balancing continuity benefits, capability gaps, and transfer costs to ensure efficient, low‑risk clinical‑to‑commercial progress.

Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Uncover the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

Integrate Ops And Supply Chain To Ensure Consistent Drug Availability

To ensure consistent drug supply, pharmaceutical companies must integrate operations and supply chain management for proactive planning and global risk mitigation.

Why Innovator Companies Need To Take Control Of Their Supply Chains

Strategic control of materials and suppliers helps innovators cut risk, manage costs, and avoid disruptions as they scale — turning uncertainty into predictability and resilience.

Built for Performance: High‑Quality Cartridge Production

A focused look at automated 3 mL cartridge processing, from washing and sterilization to monitored aseptic filling. See how precision filling, oRABS, and automation enable compliant production.

The Role Of CDMOs In Supporting Generic Drug Development

Bringing complex generics to market requires deep expertise. Find out how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end support.

Navigating Downstream Processing (DSP)

DSP failures kill commercialization timelines. Gain insight into how integrated harvest, filtration, and purification infrastructure protects product stability at scale.

De-Risking Your Bioconjugate's Path To Clinical Manufacturing

Examine the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

Targeted Modalities Set Elevated Standards For Precision

Observe how targeted modalities like ADCs and TPDs are transforming precision medicine, unlocking new treatment opportunities, and overcoming development challenges to improve patient outcomes.

SOLUTIONS

Reliable Aseptic Filling For Your Patients

USP General Chapter 382: Health Inspired, Quality Driven

Digital Solutions To Solve Manufacturing And Tech Transfer Challenges

Agile GxP Operations With A Composable Platform

Cleaning And Disinfectant Bucket System For Manufacturing

Control Software For Production Tablet Presses

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