Newsletter | June 9, 2026

06.09.26 -- Rethinking CQV In A Digital, Agile Manufacturing Landscape

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Webinar: When Art Meets Science: Creative Chromatography Solutions for Complex Small Molecules

Join this 2-part MilliporeSigma webinar series to discover how CDMOs overcome some of the toughest small molecule development challenges. Explore advanced crystallization strategies, digital chromatography tools, and innovative techniques like fraction mapping that improve purity, filtration, and scalability. Featuring real-world case studies, this series highlights how specialized expertise and approaches can transform difficult-to-handle molecules into commercially viable processes. Click here to learn more.

INDUSTRY INSIGHTS

Mixing Technologies For The Production Of Low To High Viscosity Adhesives

Understand how high shear and planetary mixing technologies optimize adhesive production. Learn to reduce cycle times, eliminate defects, and balance efficiency with your specific viscosity needs.

Open-Label Study Assessing Relative And Absolute Bioavailability

Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.

Advancing ADC Development Through Integrated ADME, DDI Strategies

Discover how tailored strategies, advanced technologies, and scientifically driven decision frameworks are accelerating the successful development and regulatory readiness of next-generation ADCs.

FEATURED EDITORIAL

Rethinking CQV In A Digital, Agile Manufacturing Landscape

While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

INDUSTRY INSIGHTS CONTINUED

Spray Drying For Combination Dry Powder Inhaler Formulations

Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.

Water For Injection: Strategic Utility And The Case For Outsourcing

Water for Injection is a critical, highly regulated component of sterile drug manufacturing. Outsourcing its production offers faster timelines, reduced risk, and improved operational and cost efficiency.

EU And PIC/S Annex 1: CCS Shortfalls After 2 Years Of Implementation

Explore how to elevate Contamination Control Strategies from static documents to inspection-ready, lifecycle tools, as well as practical approaches to Annex 1 compliance and risk-based CCS development.

Unlocking Operational Capacity With Digitalized Cleaning Validation

Digitalizing cleaning validation reduces inefficiencies, strengthens data integrity, and improves audit readiness. See how integrated systems can continuously optimize manufacturing performance.

Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology

Building the right cleanroom involves critical early decisions. Gain insight into a methodical framework ensuring flexibility, compliance, and operational readiness from concept through delivery.

A Simple And Powerful Solution For Accelerating Dissolution

Many poorly soluble drugs fail not because of low solubility, but because they dissolve too slowly. Find out how focusing on dissolution rate can unlock absorption gains using simple strategies.

How Asia And Europe Are Reshaping Biologics Manufacturing

As biologics manufacturing globalizes, companies must balance cost, capacity, risk, and control when choosing between European and Asian supply bases for clinical and commercial success.

Helium Leak Detection On Glass Cartridge Containers

Helium leak detection offers unmatched sensitivity for verifying glass cartridge seal integrity. See how this advanced method outperforms traditional tests and provides confidence in packaging.

Optimizing Product Packaging And Oral Drug Delivery With Stick Packs

Adopt stick pack technology to deliver precise, patient-centric oral doses that enhance adherence, streamline manufacturing, and support scalable, compliant pharmaceutical packaging.

What Is LearnGxP?

Stop the cycle of "click-through coma" in GXP training. Delve into how scenario-based learning and role-specific curricula reduce compliance risks and drive meaningful engagement.

Overcome Common Pre-Filled Syringe Challenges Through Partnership

The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled.

Building A Path To Approval With Effective Regulatory Support

When partnering with CDMOs, success depends heavily on collaboration with a partner that combines deep technical expertise with a proven record of regulatory excellence and operational reliability.

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Webinar: Global Regulatory Compliance for Aseptic Barrier Systems

As global sterile manufacturing standards evolve, navigating differing expectations for isolators and RABS has become increasingly complex. In this webinar, ESCO experts compare FDA, EU GMP Annex 1, PIC/S, and WHO guidance, highlighting key differences in contamination control, documentation, monitoring, and validation. Attendees will gain practical strategies for designing and qualifying aseptic barrier systems that support globally compliant, inspection-ready manufacturing operations. Click here to learn more.

SOLUTIONS

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