Newsletter | November 20, 2025

11.20.25 -- 3 [Potential] Solutions To A More Resilient Supply Chain

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Webinar: Navigating Regulatory Expectations for Injectable Packaging

As regulatory scrutiny intensifies, packaging components are taking center stage in pharmaceutical compliance. Join West experts to explore how USP <382> and the revised EU GMP Annex 1 redefine expectations for contamination control, extractables testing, and system-level validation. Gain practical insights on selecting and qualifying elastomeric components that withstand VHP decontamination while maintaining integrity—empowering manufacturers to make confident, data-driven packaging decisions. Click here to learn more.

INDUSTRY INSIGHTS

The Business Costs Of Outdated Asset Management

Learn how modern EAM and CMMS systems help manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.

5 Key Principles Of Cleanroom Particle Counting

Discover the five essential principles of cleanroom particle counting and how they ensure compliance, prevent contamination, and protect product quality in highly regulated manufacturing environments.

A Closer Look At Inspection Systems In Tablet And Capsule Production

Walk through the rigorous inspection process pharmaceutical products undergo to ensure safety and quality, from granulated ingredients to packaging.

FROM THE EDITOR

3 [Potential] Solutions To A More Resilient Supply Chain

In her opening presentation, Harney noted that there were 98 drug shortages in 2024, 40 medicines in shortage for over three years, and the average duration of a shortage has increased from three years to four years.

INDUSTRY INSIGHTS CONTINUED

Considerations In Selecting A Biomaterial For Implantable Smart Devices

Smart implants revolutionize healthcare with embedded sensors for real-time monitoring. Polycarbonate urethanes offer biocompatibility, overcoming challenges with biomaterials for safer, efficient devices.

The Hidden Costs Of Equipment Storage: What You're Really Paying For

Don't let idle assets drain your resources. Uncover the often-overlooked expenses of equipment storage, from rental fees to lost opportunity costs, and learn how to reclaim value.

The Urgency Of Pandemic Preparedness For Sterile Injectable Manufacturing

A successful large-scale public health emergency response requires adaptable manufacturing capabilities, an experienced workforce, and effective private-public partnerships.

How Digital Cleaning Validation Can Simplify Audit Readiness

Explore how to enhance audit readiness and improve compliance by shifting to a digital cleaning validation program. Learn to determine worst-case products and maximum safe carryover limits.

Don't Let Seals Break Your Batch: A Risk-Based Approach To Maintenance

Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

Safety, Containment, And Analysis Of Highly Potent Compounds

Review a comprehensive overview of the challenges, requirements, and best practices for safely working with highly potent compounds in drug development and manufacturing.

CLD To Upstream Optimization: Enhancing Biologics Quality, Productivity

Gain insight into how advanced cell line development and upstream processing strategies optimize both productivity and therapeutic effectiveness, ensuring the development of high-quality biologics.

Streamlined Blow/Fill/Seal Technology In Aseptic Packaging

The aseptic blow-fill-seal (B/F/S) process has proven to be an ideal system for the creation of a wide variety of container shapes and sizes used for packaging sterile pharmaceutical liquids. 

PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

See how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

HPAPI Drug Product Development And Manufacturing Using Micronization

Learn how to classify HPAPIs in early development and recommendations for safe product handling, from clinical manufacturing to commercialization.

Scientific Insights Into VHP Biodecontamination And BI Quality Management

VHP biodecontamination ensures aseptic manufacturing, but BI variability challenges validation. Addressing rogue BIs and regulatory shifts strengthens contamination control and process reliability.

Innovative AI Software Solutions Driving Biomarker Research Efficiency

Find out how Genedata Profiler and Leica Aivia AI-powered tools streamline biomarker discovery, enhance data analysis, and improve research efficiency in personalized medicine.

Reaching BLA Success: Fast-Track Approach To Process Characterization

Discover how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

SOLUTIONS

Effortless Automation With A Nucleic Acid Purification (NAP) Suite

Keep A Close Eye On Quality With Excipients For Drug Formulation

Cleanroom Pass Though Box For Drug Manufacturing

Integrated Operations Produce Top-Tier Raw Materials

Reduce The Burden Of Software Validation Testing

A Globally Adopted Disposable Autoinjector

Internal Laboratory

High Potency Handling Capabilities And Support

Access To Medicine In A Way The Industry Hasn't Seen Before

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