Newsletter | April 2, 2026

04.02.26 -- Generative AI Can Write The Code, But Who Builds In The Quality?

INDUSTRY INSIGHTS

Addressing Raw Material Handling Challenges By Dry Granulation

Handling multi-ton quantities of buffers, salts, and stabilizing chemicals in manufacturing can be difficult. See how dry granulation improves efficiency, safety, and process reliability.

The AI Revolution In Pharma: Moving From Reactive To Predictive

Discover how AI converts traditional environmental monitoring into predictive intelligence that prevents contamination events before they occur, fundamentally changing cleanroom quality control.

Robotics And AI In Pharma: Driving The Next Wave Of Innovation

Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.

FEATURED EDITORIAL

Generative AI Can Write The Code, But Who Builds In The Quality?

Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

INDUSTRY INSIGHTS CONTINUED

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.

The Strategic Power Of Medical Device Coatings

Medical device coatings are shifting from basic finishes to strategic tools that boost performance, safety, sustainability, and innovation through stronger partnerships and smarter materials.

Preparing Pharma Operations For An Autonomous Future

Biopharma’s push for faster delivery is accelerating a shift from automated to autonomous manufacturing. Find out how self‑optimizing systems are shaping the next frontier.

Powering Drug Development With Advanced AI Retrosynthetic Analysis Tools

Review advanced retrosynthetic analysis services and how these tools empower better, more efficient development of innovative small molecule drugs.

Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

Outlined here are the inherent benefits of PFS and how they relate to the delivery of drugs, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a flexible CDMO is the key.

Quantifying Endotoxins Via Absorbance Or Fluorescence

Examine how endotoxin assays use Factor C activation to generate measurable absorbance or fluorescence signals, with guidance on implementing scalable workflows.

A Surprising Truth: CDMO Operations Should Be Boring

Operational excellence in drug manufacturing comes from predictability. Standardized, consistent processes reduce volatility and ensure steady, high‑quality progress.

The Rising Cost Of Product Recalls In Life Sciences

Product recalls are becoming a major concern in life sciences. Learn why your company must act now to strengthen quality systems and reduce risk across pharmaceuticals, devices, and biologics.

The Rise Of Targeted Modalities In Pharmaceutical Development

Targeted modalities are pushing the boundaries of technology and therapeutic effectiveness. Their potential to transform patient care depends on leveraging the right expertise and partnerships.

Elevating Environmental Monitoring Trending: From Data To Insight

Move beyond raw data by using heat maps and site-specific limits to identify contamination hotspots. Transform your environmental monitoring into a proactive strategy for operational excellence.

Developing A Large-Scale Tangential Flow Filtration Process

Uncover a process that can be modified to fit your downstream process and serves as a complete solution for concentration and diafiltration.

Ophthalmic Product Package Inspection

Microscopic leaks in ophthalmic packaging can compromise sterility. Delve into how advanced vacuum decay testing delivers fast, reliable results, detecting defects as small as 5 microns.

SPONSOR

2026 ISPE AI in Life Sciences Summit – Powered by GAMP®

The 2026 ISPE AI in Life Sciences Summit – Powered by GAMP® will be held 22–23 June in Boston, offering insight into how AI is advancing within the life sciences sector. Sessions explore model governance, data integrity, explainability, and inspection ready design. Attendees gain practical frameworks for integrating AI into GxP workflows and guidance on how to meet evolving regulatory expectations. LEARN MORE

SOLUTIONS

Does Blow/Fill/Seal Aseptic Packaging Make Sense For Your Drug?

Drug-Drug Interaction (DDI) Studies

A/L/P Assembly, Label And Packaging

X-Ray Blister Pack Inspection

Two Decades Of Sterile Manufacturing Excellence

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