Newsletter | October 10, 2025

10.10.25 -- New FDA White Paper Ties Quality To Financial Benefits

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Considerations In Sterility Testing And Assurance

Mammalian cells play a crucial role in the biopharmaceutical industry for producing complex molecules such as recombinant proteins and monoclonal antibodies. Ensuring the safety of these products requires rigorous control of microbial contamination throughout cell culture batches and downstream processing. Sterility assurance is vital in this context, encompassing all measures aimed at eliminating viable microorganisms that could jeopardize patient safety. Learn more about sterility testing and assurance here.

INDUSTRY INSIGHTS

Industry 4.0 Project Stuck In Pilot? Address These 5 Challenges

Industry 4.0 is gaining momentum, but scaling remains a challenge. Discover why a robust industrial data strategy is essential and the top five barriers keeping manufacturers stuck in pilot purgatory.

Driving Sustainability In Spray Drying Through Enabling Technologies

By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.

Mixing Cannabis-Infused Products

Gain insights from a pharmaceutical equipment manufacturer on factors cannabis manufacturers should consider when they're looking to purchase a mixer.

FEATURED EDITORIAL

New FDA White Paper Ties Quality To Financial Benefits

The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

INDUSTRY INSIGHTS CONTINUED

Maximizing ROI In Pharma: Extracting Value From Analysis And Reporting

Explore strategies for maximizing ROI in pharma through advanced analytics, streamlined operations and an interconnected data management platform.

Stick-Pack Benefits For Pharmaceuticals And Nutraceuticals

Uncover the key advantages of stick-pack formats for pharmaceuticals and nutraceuticals, from enhanced product safety and cost-efficiency to improved compliance and marketability.

Vial Fogging: Practical Considerations For Vial Selection

Vial fogging is a common phenomenon observed in lyophilized biologic drug products. Examine two case studies that review critical factors contributing to vial fogging and inform vial selection decisions.

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

Accelerating Sterile Injectable Innovation Through Strategic Outsourcing

Sterile injectables are vital for modern medicine. Learn how outsourcing manufacturing to a CDMO can accelerate development and commercialization.

Accelerating Clinical Development: Modern Tools In Process Chemistry

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

A New Look At Subcutaneous mAb Delivery Using Nanoformed Particles

A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. See how the particle size of the mAb impacts the overall behavior of the drug product.

Next Generation Sequencing In Viral Safety Testing

Next Generation Sequencing offers a sensitive, high-throughput solution for detecting adventitious viral agents to improve safety and accelerate regulatory-compliant product development.

How To Avoid Sticking And Picking In The Tableting Industry

Find out more about strategies to mitigate sticking and picking risks in the tablet industry, and how you can foster improved tablet production processes to ensure higher quality and consistency.

The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally

Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.

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. 

Reconstituted Nasal Epithelium As A Model For Nasal Drug Delivery

Reconstituted nasal epithelium (RNE) offers a human-relevant model for nasal drug delivery, outperforming frozen mucosa and aligning better with clinical outcomes for opioid formulations.

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Join us for Pharmaceutical Online on October 15 at 11 AM ET! Chief Editor Katie Anderson hosts a free, interactive webinar—Balancing GLP-1 Quality with Demand—featuring expert panelists discussing peptide manufacturing, supply chain strategies, assay development, tech transfer, and more. Sponsored by Waters. Register now!

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