Newsletter | November 14, 2025

11.14.25 -- Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms

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Biopharma Supply Reimagined: Manufacturing made more robust and customer-centric

Join our upcoming webinar “Manufacturing made more robust and customer-centric”, on November 18th, 2025, and explore how supply chains and manufacturing must transform to meet customer needs in an ever-changing environment. Register now and discover how in-region manufacturing can significantly enhance supply resilience. How fostering a risk management culture can boost transparency throughout the supply chain. How supply chains evolve towards more agility in pilot initiatives.

FOCUS ON SUPPLY CHAIN

Pfizer's Accord For A Healthier World Challenges Stability Study Norms

The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

A Comparative Analysis Between Liquid Nitrogen And Mechanical Freezers

Explore the differences between liquid nitrogen and mechanical cryogenic freezers, and learn how each method supports scientific, medical, and industrial storage needs.

How Blast Freezing Affects The Quality Of Bottled Drug Substance

Uneven ice formation during bottle freezing creates a "Volcano Effect," pushing solutes into highly concentrated zones. This test-based study explains this risk to drug substance quality.

Preventing Gas Ingress In Single-Layer Fluoropolymer Bags

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.

SUPPLY CHAIN SOLUTIONS

Fluid Transfer Sets - Charter Medical

FOCUS ON PROCESS ENGINEERING

Three Key Actions To Minimize Dead Volumes

Minimizing liquid dead volume helps labs conserve costly reagents and scarce samples while boosting assay throughput. Learn how advanced liquid level detection technologies are driving efficiency.

Redefining Process Design And The Evolution Of Critical Process Parameters

Effectively managing process parameters and quality attributes is vital for successful drug development. Learn how a Quality by Design approach can optimize your processes and ensure product quality.

Accelerating Gene Therapy Development For NEDAMSS

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Linear Scalability In Turbulent‐Jet Mixing For Nanoparticle Processing

Understand how turbulent-jet mixing ensures predictable and reproducible nanoparticle size and uniformity across all scales, accelerating development and regulatory readiness.

ADCs: The Next Phase Of Innovation

Explore the pivotal advancements in ADCs that focus on high-DAR, multispecific designs, and novel payloads, while addressing challenges in manufacturability, scalability, regulatory acceptance, and more.

Tips For Viral Vector Production

Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

The Value Of Tailoring Transposons For Optimized Biotherapeutic Production

By leveraging transposase-mediated technologies together with transposon design to achieve semi-targeted integration, drug developers can more efficient and consistent biotherapeutic protein production.

Developing New Medicines Through Artificial Intelligence

Embrace the future of drug development by leveraging AI and innovative protein synthesis technologies to accelerate the creation of effective therapies and transform patient outcomes.

Advancing Life Sciences Automation

Explore how Life Sciences teams are aligning digital innovation with patient outcomes through connected systems, scalable data strategies, and collaborative development.

Understanding Biotherapeutic Peptides And GLP-1 Receptor Agonists

Biotherapeutic peptides offer enhanced safety and efficacy over traditional drugs. Learn why rigorous impurity profiling is vital to ensure product quality, patient safety, and regulatory compliance.

The Case For Modernizing Small-Volume Aseptic Processing

Tube welding and biosafety cabinets present significant costs and risks for small-volume aseptic processing. Modern single-use aseptic connectors offer a more efficient alternative.

Coatings For Bioreactor Scale-Up vs. Other Stem Cell Production Systems

Scaling up stem cell production presents unique hurdles. Discover crucial considerations, from initial development to large-scale manufacturing, to ensure cell quality and successful outcomes.

Closing The Loop: A Simple And Scalable Cell Processing Platform

Transitioning from manual to automated cell processing is key to therapeutic success. This versatile single-use system can simplify operations and reduce variability throughout manufacturing.

Fast And Sensitive Mycoplasma Detection Workflow

Digital PCR enables fast, sensitive mycoplasma detection in cell-based products. Learn how this workflow improves accuracy, reduces delays, and supports reliable decision-making.

Transient Expression Technologies For Antibody Production

Review studies that showcase the potential of the CHOgro Expression System in early stage drug development, where high titer antibody production in suspension CHO cells is crucial.

PROCESS ENGINEERING SOLUTIONS

Antibody Production: Scale-Up Menu - Cytiva

Higher Titers In Small-Cell Culture Systems And Bench-Scale Bioreactors - MilliporeSigma

It's Time To Intensify - Sartorius

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