Newsletter | August 28, 2026

08.28.26 -- A Much-Improved Approach For Understanding And Managing Safety Risks

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Why Spray Drying Is Gaining Attention As A Biologics Lifecycle Management Strategy

As biologics face a looming $300bn patent cliff, pharmaceutical companies are exploring new ways to extend the value of established assets. This paper examines why spray drying is emerging as a powerful lifecycle management strategy, enabling novel delivery routes, enhanced patient convenience, and new intellectual property opportunities. Discover how this specialist technology could help differentiate biologics, support patent extension, and why access to the right expertise is becoming increasingly critical. Click here to learn more.

INDUSTRY INSIGHTS

 

What's Ahead For Medical Device Manufacturers

Medical device manufacturers face growing complexity in 2026, needing stronger partnerships, advanced biomaterials, and resilient supply strategies to meet shifting market demands.

 

New Approach Methodologies: The Future Of Toxicology And Safety Testing

NAMs are transforming toxicology with human-relevant, non-animal approaches. Learn what defines a NAM, how these methods work together, and why adoption is rapidly accelerating.

 

Get Smoother Separations, Faster: Troubleshoot Method Development

Strong chromatography requires more than separation. Fine-tuning pH, columns, and system volume prevents poor peak shape, while modeling tools streamline optimization for reproducible results.

FEATURED EDITORIAL

A Much-Improved Approach For Understanding And Managing Safety Risks

Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

 

INDUSTRY INSIGHTS CONTINUED

 

Pharmaceutical Technology Transfer Steps

Streamline technology transfer by following a structured, multi-step framework. Mitigate operational risks, maintain process validation, and ensure regulatory compliance with confidence.

 

Technology For Taste-Masking In Oral Antimalarial Formulations

Drive forward the development and adoption of taste‑masked ASAQ micropellets so children in low‑resource settings can receive life‑saving antimalarial treatment that is effective and easy to take.

 

All Eyes On X-Ray Inspection For Big Box Retailers

Major retailers are mandating x-ray inspection. Uncover why this technology is crucial and its capabilities beyond contamination detection to encompass vital quality and integrity checks.

 

Overcoming Excipient Risks And Challenges For Parenteral Formulations

Excipients are essential to parenteral formulations, which help protect APIs, enhance stability, and ensure safety. See how strategic excipient selection can optimize drug performance.

 

How Proactive Regulatory Planning Supports Improved Drug Formulation

Integrating regulatory strategy with R&D planning early in drug development helps to minimize formulation risks and align manufacturing with compliance while preventing costly delays.

 

AI Implementation To Enhance Quality

Gain insight into how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

 

Why Spray Drying Is Gaining Attention

Facing patent cliffs, pharma companies can leverage spray drying to reformulate complex biologics, enabling non-invasive delivery, boosting patient convenience, and securing new patents.

 

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

 

Manufacturing Biologics: Purification Science And Resin Applications

Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.

 

The Hidden Costs Of Paper Logbooks

Stop losing time and capacity to manual paperwork. Delve into how digital workflows eliminate compliance risks and unlock the actionable data needed to optimize life sciences manufacturing.

 

Novel Process Indicators For Hydrogen Peroxide Decontamination

Immediate, quantifiable verification replaces seven-day incubation periods. Discover how enzyme-based indicators optimize hydrogen peroxide decontamination.

 

How Inline Checkweighing Optimizes GLP-1 Vial And Pen Assembly

Take a look at how inline checkweighing helps manufacturers scale GLP-1 vial and pen production while maintaining dosing accuracy, maximizing throughput, and supporting regulatory compliance.

 

Comparative Analysis Of Batch And Continuous Processes

Examine a comparative analysis that showcases the superior performance of continuous processing over traditional batch methods, highlighting key improvements in efficiency and environmental impact.

 

How To Optimize Labeling In A Pharmaceutical Environment

Accurate, readable pharmaceutical labels are crucial. Navigate considerations like printing, application tolerances, and inspection to select the right machinery for your production environment.

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Webinar: Design Verification Done Right: Smarter Strategies for Prefillable Syringes

Design verification for prefillable syringes can be challenging as regulatory expectations, drug-device integration, and testing requirements evolve. This webinar explores a risk-based framework for building a defensible verification strategy. Using a real-world case study, learn how to translate user requirements and product targets into test plans, acceptance criteria, and aging considerations. Gain insights to strengthen decisions and reduce ambiguity. Click here to learn more.

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