Newsletter | September 29, 2026

09.29.26 -- You Can't CAPA What You Can't Classify

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Webinar: Beyond Sustainable Packaging: Reducing Plastic While Strengthening Brands and Industrial Performance in Life Sciences

How can life sciences manufacturers create more sustainable packaging without compromising premium aesthetics? Join Körber to explore an integrated approach combining recyclable materials, advanced inspection, machine integration, and qualification. Learn how smarter packaging strategies can reduce plastic use, minimize risk, improve efficiency, and accelerate commercialization while turning sustainability into a competitive advantage. Click here to learn more.

INDUSTRY INSIGHTS

 

Top Considerations Of In-Line Checkweighers In A Manufacturing Process

Explore the factors to consider when weighing the options and the range of technologies available to meet your quality, production, and ROI requirements.

 

Pouching Solutions For Sterile And Moisture-Sensitive Devices

Aseptic pouching requires specialized mechanical segregation and sterile vacuum handling. Discover how targeted engineering maintains Grade A compliance.

 

7 Ways Customization Delivers Laboratory Automation

Standard automation can handle individual tasks, but complex assays often need more flexibility. Learn how customization helps labs connect systems, adapt workflows, and build automation strategies.

FEATURED EDITORIAL

You Can't CAPA What You Can't Classify

An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

 

INDUSTRY INSIGHTS CONTINUED

 

5 Must-Haves From Your Peptide Building Block Supplier

Whether you are just entering the peptide market or scaling an established product, access to a reliable supply of high-quality building blocks is critical to running a successful peptide program.

 

Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications

Gain insight into how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.

 

Liberate Your Workflow: Flexible, Multi-Technique Chemical Data Analysis

Scientific workflows are no longer confined to one device. Cross-platform access to analytical data is becoming essential, helping researchers stay productive and collaborate more effectively.

 

How To Capture Growth In The Expanding Metabolic Drug Market

Driven by GLP-1 success and rising obesity rates, R&D investment in metabolic disease therapies now rivals oncology, demanding rapid development to overcome market challenges.

 

How Portable Tools Can Help Improve Drug Development Outcomes

As drug pipelines shift toward smaller, more complex therapies, portable bioprocessing tools are helping teams reduce delays, improve data integrity, and enable flexible manufacturing.

 

Drug Substance To Fill-Finish Handoff: What Sponsors Need To Know

Effective drug substance handoff to fill-finish manufacturing depends on early collaboration, clear communication, and proactive planning to reduce risks, ensure quality, and maintain timelines.

 

The Art And Science Of Getting Tech Transfer Right First Time

Technology transfer connects drug development to manufacturing through early engagement, open knowledge sharing, and data-driven methods like Design of Experiments to safely advance therapies.

 

Navigating Nitrosamine Impurities In Pharmaceutical Drug Development

Understanding formation mechanisms and potency categorization allows developers to mitigate risks early, ensuring regulatory compliance and patient safety without compromising product performance.

 

An Approach To Regulatory Compliance In Japan

Japan's market demands J-DMF registration, Foreign Manufacturer Accreditation, and GMP compliance. Find out how CDMO support simplifies PMDA submissions and accelerates market entry.

 

A Powerful Non-Destructive Tool For Tablet Characterization

Uncover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.

 

Supporting Tech Transfer With A Prefillable Syringe System

Observe how aligning packaging strategy with technology transfer requirements can accelerate timelines, control costs, and support successful injectable drug product manufacturing.

 

Episodic Vs. Continuous: Which Operating Model Is Carrying You Forward?

Transitioning from episodic audit prep to continuous readiness protects clinical timelines. Evaluate your quality operating model to support scalable growth today.

 

Scale-Up And BLA Planning For Microbial Biomanufacturing

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

 

Identifying Worst-Case Locations Assessing Homogeneity Using BIs And EIs

Combine quantitative enzyme indicators, computational fluid dynamics, and traditional biological indicators to improve VPHP isolator validation and process confidence.

 

Breaking The Bottlenecks In Regenerative Medicine Manufacturing

See how tiered automation platforms resolve cell therapy manufacturing bottlenecks, enabling a seamless transition from clinical trials to high-volume commercial supply.

 

From Batch, To Continuous Chemistry, To Continuous Processing

Take a look at how understanding the transport phenomenon in the boundary layer can allow us to engineer the flow to manage the rate-limiting step and intensify the process.

 

What Pharmacies Often Miss In USP <800> Compliance

Master USP <800> compliance by transitioning from standalone equipment to an integrated system design. Review key protocols for a multi-layered strategy to mitigate cumulative drug risks.

SOLUTIONS

The Simplest, Most Powerful Digital PCR Workflow Family

Industry-Leading Differential Scanning Calorimeter

Aseptic Filling Quality Through Continuous Improvement

Resilience: Accelerating Innovation With Unified Quality

Multiparticulates For Modified Release Systems

Process Liquids And Buffers To Accelerate Your Speed-To-Market

Aseptic Fill/Finish Service

The Importance Of Having A Strong Reject Characterization Program

Manufacture High-Quality Products With Streamlined Compliance

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