Newsletter | May 12, 2026

05.12.26 -- A 5-Step Foundation For Early CQV Involvement

SPONSOR

Register for the Pharmaceutical Online Live event on May 27, at 11am Eastern for Analytical Strategies for High-Volume GLP-1 Manufacturing. The talk will highlight opportunities to improve scalability through automation and streamlined method platforms, positioning analytics as a central enabler of reliable, high-volume GLP-1 manufacturing. This virtual discussion will be moderated by Chief Editor Katie Anderson and is completely free to attend thanks to our sponsors Waters Corp. and Agilent.

INDUSTRY INSIGHTS

High Shear Mixer Considerations For The Cannabis Industry

The growing demand for cannabis-infused products provides an opportunity and a challenge for manufacturers. Gain insight into high shear mixers and how they can be used in a variety of ways.

A Guide To Analytical Characterization Of Complex Molecular Formats

A thorough and adaptable analytical strategy is essential for navigating the complex mAb market. This approach boosts the likelihood of market approval and unlocks the full potential of these therapies.

Advancing High Potency Manufacturing

Advance potent drug manufacturing through tighter containment, thoughtful process engineering, and closed handling that protects workers while improving efficiency and scale.

FROM THE EDITOR

A 5-Step Foundation For Early CQV Involvement

All too often, a project’s issues show up in CQV, and it is there that blame is pointed. However, these issues start earlier and were entirely avoidable with proper planning.

INDUSTRY INSIGHTS CONTINUED

Trends In Cold Chain Storage For Biologics

Packaging is critical, as biotechnology products requiring colder storage become more valuable. Find out how you can improve your temperature-controlled supply chain and meet cold chain storage demands.

How To Inspect Used Stainless Steel Tanks And Reactors To Avoid Risk

Used stainless steel tanks can cut costs and lead times, but only with a thorough evaluation. Verify specifications, inspect welds and surfaces, and confirm dimensions to ensure reliable performance.

Accelerating Batch Release With Agentic AI

Agentic AI is redefining manufacturing by accelerating batch release and sharpening real‑time insights. With the right data and governance, teams can gain faster analytics and improved efficiency.

Protecting Product Integrity Through Cold Chain

Reliable temperature‑controlled storage, monitoring, and safeguards keep sensitive materials stable from fill to patient, protecting quality and ensuring safety throughout the cold chain.

Realizing The Potential Of The Evolving CDMO Ecosystem

Pharma is shifting to integrated manufacturing partners to handle complex drugs. Technical synergy and global alignment boost resilience and speed patient access.

How A Specialized CDMO De-Risks Complex API Development

Rising API complexity and AI-driven chemistry require specialized CDMOs with technical expertise in hazardous or chiral synthesis to successfully navigate the transition to GMP manufacturing.

Optimize Time, Space And Cost With Inline Buffer Formulation And System

Discover how integrating inline buffer formulation with chromatography reduces buffer waste by 50% and delivers a 710% ROI, transforming downstream efficiency and sustainability.

A Pragmatic Approach To Developing A Rare Disease Drug

We are beginning to see a rise in the interest of developing "orphan drugs," or pharmaceutical agents intended to treat rare diseases. Delve into the challenges and considerations.

Move Beyond LAL

Uncover how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.

Advancing Drug Product Quality Through AVI And Infrastructure

Automated visual inspection combines robotics, precision imaging, and sophisticated defect-recognition software to provide a scalable solution for expanding pipelines and rises in production volumes.

The Identifier Software: Foundational Modules

Be a leader in the eyes of the FDA with an innovative defect management software. Take the next steps into the future of Pharma 4.0.

How Our Polyurethanes Can Enhance Your Medical Device Designs

Learn more about a family of medical-grade polyurethanes engineered for high performance, biocompatibility, and reliability in advanced, critical medical device applications.

SPONSOR

Pharmaceutical Online, Federal Equipment and Techceuticals bring you Virtual Pharma Expo - a one-day, themed event with live equipment demonstrations and presentations by leading experts from pharmaceutical equipment providers for aseptic fill/finish manufacturing & packaging - all from the convenience of your office! Whether you're looking to optimize your current processes or explore new technologies, this event will provide valuable knowledge and practical insights.

SOLUTIONS

Integrated ADC Offering: From Concept To Commercialization

Bend, Oregon, US: Advancing Compounds Through Early Development

Resilience: Accelerating Innovation With Unified Quality

Lab-Scale Aseptic Filling System For Cell And Gene Therapy

Asset Management Built For Life Sciences

Supply Chain Management Consulting Services

See Where Quality Begins In Workcell Manufacturing

The Help You Need- Available Where And How You Need It

Connect With Pharmaceutical Online: