Newsletter | January 17, 2025

01.17.25 -- Will FDA Finally Enforce DSCSA Interoperability In 2025?

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The peptide market is booming, driving manufacturers to enhance processes and capacity. What key changes are shaping peptide manufacturing? How can continuous manufacturing boost efficiency and meet demand? Don’t miss our inaugural Pharmaceutical Online Live digital event on January 22nd. Registration is free thanks to the support of Federal Equipment Company.

INDUSTRY INSIGHTS

5 Areas To Focus Your QRM Strategy For Sterile Drug Products

Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.

Understanding Biosafety Levels

Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

A Roadmap For Implementing Analytical QbD

Discover how an analytical QbD approach ensures that analytical methods are not only effective but resilient to variations, ultimately enhancing the reliability and accuracy of the data generated.

Revolutionizing Lab Operations: Embracing Radical Simplicity

The lab of the future is designed to increase efficiency, enhance accuracy, and ensure flawless execution. Read about Pharma 4.0, predictive analytics, and the future of lab automation and operations.

Compressed Gas Systems In Aseptic Manufacturing

Learn about compressed gas systems and why effectively identifying and managing the risks associated with these systems is critical for maintaining product quality and ensuring compliance with GMP.

A New Approach To Isolator Decontamination

How can you address the decontamination challenges associated with isolated fill-finish operations? New innovations are being implemented to ensure superior sporicidal reduction and operational safety.

Enhance Immuno-Oncology Research With Knock-Out Cell Lines

Using the PD-L1 pathway as a case study, delve into techniques designed to help you thoroughly understand immunological mechanisms.

How To Successfully Scale QC For Rapid Growth

Learn how one CDMO successfully streamlined and modernized its QC workflows and processes to address challenges related to the increasing demand for cell and gene therapy manufacturing services.

How To Unlock The Secret To Repeatable, Scalable Low Turnover

Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

A New Mindset For Combination Product Development

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

Spray-Dried Dispersions Enable Local Delivery For Lung Cancer

Learn more about spray drying, and explore case studies detailing its success as a critical tool in developing innovative and effective lung cancer therapies.

Recommended Mixing Equipment For Liquid Supplements

Explore the benefits of preparing liquid supplements in a multi-shaft mixer designed for bulk agitation, high-speed solids dispersion, and superior heat transfer.

FEATURED EDITORIAL

Will FDA Finally Enforce DSCSA Interoperability In 2025?

Two experts weigh in on the persistent problems surrounding the Drug Supply Chain Security Act and its upcoming enforcement deadlines.

SOLUTIONS

A Technology-Driven CDMO Delivering Integrated End-To-End Services

Sampling And Dispensing Services

A Leading Digital Validation Platform For Life Sciences

Dry Powder Inhaler Services

Capacity Update October 2024: Small Molecule

Development Of Novel Synthetic Routes

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