Newsletter | July 11, 2025

07.11.25 -- Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms

INDUSTRY INSIGHTS

JCA And Project Orbis Impact On The Revenue Potential Of A Product

Contrary to concerns about price erosion, new analysis suggests Joint Clinical Assessment and Project Orbis will likely increase European oncology product revenue by enabling faster market uptake.

Handling Protocols: Key Considerations In The Highly Potent API Market

Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

Aseptic Blow/Fill/Seal Technology Vs. Traditional Aseptic Processing

See why blow-fill-seal technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

The Critical Role Of Weight Uniformity In Tablet Manufacturing

For tablet manufacturers, tablet weight uniformity plays an essential role in ensuring pharmaceutical products deliver accurate amounts of key ingredients in a formulation.

Overcoming Manufacturing Challenges For Accelerated Drug Development

Expedited development programs require adapting to accelerated development timelines. The challenge is to build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process.

A Guide To The Ultimate Product Improvement Tool

Find out how to transform your product quality review that emphasizes systematic evaluation and improvement of product quality, highlighting automation benefits through modern software.

How Two Life Science Leaders Unlocked Pharma 4.0 Success

Gain valuable insights from digitalization leaders on how some life sciences manufacturers are successfully scaling their Pharma 4.0 initiatives beyond the pilot stage and paving the way forward.

PUPSIT Without The Pain: Practical Solutions For Implementation

Uncover the critical role of pre-use post-sterilization integrity testing in quality risk management, as well as learn about integrity testing and innovative filtration systems.

Demystifying Lyophilization: Understanding The Freeze-Drying Process

Advancements in lyophilization technology and research have helped overcome inherent challenges and ensure the safety and efficacy of lyophilized pharmaceuticals.

From Batch, To Continuous Chemistry, To Continuous Processing

Read 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.

From Powder To Particles With Jet Milling

Watch to understand the jet milling process and Quality by Design approach for inhalation drug delivery and their potential applications in drug development.

A Roadmap To Expedited Review Pathways

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

Innovative AI Software Solutions Driving Biomarker Research Efficiency

Join our webinar to explore how Genedata Profiler and Leica Aivia AI-powered tools streamline biomarker discovery, enhance data analysis, and improve research efficiency in personalized medicine.

Sustainability Considerations For Drug Delivery Device End-To-End Solutions

Reveal how to address the gradual unlinking of economic activity from the consumption of finite resources and the removal of waste to support and help prevent a global climate catastrophe.

FEATURED EDITORIAL

Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms

Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

SOLUTIONS

Unlocking A Reliable Supply Chain

Scientist Spotlight: Daniel Kirschner

Digitally Transforming Scientific Discovery, Research And Development

Regulated Document Review

Quality, Data, And Analytical Solutions

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