Newsletter | August 29, 2025

08.29.25 -- George Tidmarsh Named CDER Director

INDUSTRY INSIGHTS

A Novel Injection Technique For Polar Heterocycles, Oligopeptides

By improving sample loading uniformity and reducing solubility-related artifacts, see how a multiple-injection approach enhances the practicality and effectiveness of SFC for difficult-to-purify substances.

Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications

Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.

The Importance Of Container Closure Integrity (CCI) Feasibility Testing

In the CCIT space, one single inspection technology cannot be used for every type of pharmaceutical product. You should always weigh the various factors to determine the ideal inspection methodology.

Solving Data Challenges In Life Sciences Across The Enterprise

Unlock smarter pharmaceutical data management with an innovative platform to streamline compliance, accelerate tech transfer, and harness real-time insights to drive innovation.

Temperature Dependence On Reversed-Phase Separations

Column temperature critically affects the reversed-phase separation of fatty acid-modified GLP-1 RAs and impurities. Learn how precise control enhances resolution and reproducibility.

Comparative Analysis Of Batch And Continuous Processes

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

Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Find out how integrating an innovative strategy transformed their workflow.

Digital Maturity In Life Sciences Quality And Manufacturing

Amid strict regulations and complex challenges, gain insight into how your dedication ensures quality and pushes the boundaries of what’s possible in public health.

Considerations For Tangential Flow Filtration Process Development

Optimize your TFF process with single-pass technology by joining experts Mike Dango and Michael Brauchle as they share key strategies for scalable, efficient filtration process development.

Effective Procurement Strategies For Labeling Systems

What is actually behind the procurement of a pharmaceutical labeling machine and how does the process work? You can find out here what the path to your pharmaceutical labeling machine looks like.

Considerations For Large-Scale API Production

Uncover expert insights on selecting the right CDMO partner for large-scale API production as well as key considerations to ensure your small molecule API program is successful.

Accelerated Peptide Drug Development And Clinical Strategies

Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

FEATURED EDITORIAL

George Tidmarsh Named CDER Director

Tidmarsh has over 30 years of experience in biotechnology, clinical medicine, and regulatory science and has authored 143 scientific publications and patents.

SOLUTIONS

Can Your Facility Cleanliness Pass Regulatory Scrutiny?

A Leading Digital Validation Platform For Life Sciences

Carbohydrate And Organic Acid LC Columns

Dry Powder Inhaler Services

Isolated Fill-Finish System: Available For Quick Delivery

Cleaning And Disinfecting For Viruses And Other Pathogens

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