Newsletter | November 14, 2025

11.14.25 -- Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards

SPONSOR

With more than 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class GMP sterile fill and finish services, deep scientific and technical expertise, and a uniquely collaborative approach to support our customers’ strategic objectives. As two industry-leading CDMOs in the ADC field, MilliporeSigma and Simtra have forged a Strategic Alliance for Drug Substance and Drug Product ADC Manufacturing with the shared goal to delivering your drug development program to market more efficiently.

INDUSTRY INSIGHTS

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.

Effects Of X-Ray Inspection On Pharmaceutical Products

Some manufacturers still have reservations about adopting X-ray inspection as a safe method of product inspection. Explore the potential effects of X-ray inspection on pharmaceutical products and more.

Development Of RP Methods For The Analysis Of Synthetic Peptides

Uncover the expanding role of synthetic peptides in drug development and learn how advanced RP chromatography methods are vital for impurity profiling to ensure safety and efficacy.

FEATURED EDITORIAL

Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

INDUSTRY INSIGHTS CONTINUED

Match Your Development And Manufacturing Path To Your IND Milestones

The drug development journey is long, expensive, resource-straining, and risky. Discover how to maximize the value of early-phase material and match your development path to your IND milestones.

Challenges In Ophthalmic Formulations Through Polymer Selection

The growing demand for ophthalmic drugs is driven by aging populations and increased screen time, which contributes to rising eye conditions. Explore innovative solutions in ophthalmic drug development.

An Introduction To High Voltage Leak Detection (HVLD) Technology

A majority of methods used to detect pinholes, cracks, and defective seals in containers are destructive. Gain insight into High Voltage Leak Detection and why it is free from these shortcomings.

Building An Effective Contamination Control Strategy For Sterile Filtration

Watch to find out about important considerations for final sterile filtration throughout product development and for performing pre-use post-sterilization integrity testing.

Life Sciences And Automation Companies Deliver The Future—Together

Accelerating treatment development is now a baseline expectation. See how industry leaders are overcoming the technology transfer bottleneck through collaboration.

How Intelligent Automation Transforms CQV Workflows

Read how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.

NMR And Mass Spectrometry In Pharmaceutical Development

Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.

Peptones And Vaccines: A Synergistic Approach To Enhanced Production

Enhance your vaccine manufacturing with peptones. Examine their benefits, analyze data-driven productivity gains, and learn integration strategies in this informative, on-demand session.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

Understand more about a disposable pen for Liraglutide 3.0 mg that demonstrated comparable usability to the reference device, helping de-risk ANDA submissions through proactive human factors evaluation.

From First-In-Human To Proof-Of-Concept — Quicker, Smarter, Streamlined

Review examples of smarter SAD/MAD trial designs, including multi-part and hybrid protocols, regulatory foresight, recruitment considerations, and operational strategies that keep programs moving.

Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production

Get strategies for meeting the updated GMP Annex 1 in small-batch aseptic filling. Learn about contamination control, quality management, and equipment design for high-value products.

Inline Buffer Formulation: A Facility Operations Game Changer

Inline buffer formulation leverages real-time, precise buffer preparation throughout production, enabling agile, efficient, and scalable manufacturing processes that save time and resources.

A Solvent-Free, Fusion-Based ASD Manufacturing Process

Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.

Prioritizing Data Security Through Digital Transformation

Integrating advanced digitalization solutions and prioritizing data security can accelerate drug development while reducing costs and ensuring consistency across a global network.

Increase Spray Drying Throughput For Brick Dust Compounds

We discuss three enabling technologies designed to improve drug solubility in organic solvents for spray drying and define the advantages and risks of each technology.

SOLUTIONS

Sterile Drug Product

Accelerate Innovation With Compliant Software Solutions

High-Purity Analytical Solvents: Consistent Quality For Applicants

Change Management In Cleaning, Disinfection, And Bio-Decontamination

Are Your Supply Chains Resilient Enough To Roll With The Punches?

Capacity Update October 2025: Fill/Finish

The Easy Way To Get Quality Components Delivered Quickly

Two Decades Of Sterile Manufacturing Excellence

Modular Biopharma Cleanrooms

SPONSOR

Join life sciences experts and global regulators this 9–10 December for the 2025 ISPE Pharma 4.0™ Conference in Barcelona, Spain, or virtually. This year's agenda spotlights how innovative enabling technologies including AI, machine learning, virtual and augmented reality, industrial internet of things, GxP cloud platforms, robotics, advanced modeling, and automation, are addressing key challenges like drug shortages and improving product availability. LEARN MORE

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