Newsletter | September 13, 2022

09.13.22 -- Align CMC Strategy With Clinical Path Requirements And Timelines

New Podcast Episode
Industry Insights
Align CMC Strategy With Clinical Path Requirements And Timelines

Manufacturers must understand the challenges associated with creating a CMC strategy, and the expertise and resources needed to execute it, in today’s crowded and diverse market.

Navigating CMC Requirements For Accelerated Development

CMC activities are critical to quickly and efficiently moving promising new drug products to market. Careful planning and early integration of an effective CMC strategy contributes to project success.

Overcoming Limitations To Achieve Uniform Dosing

An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

The Identification Of A MicroRNA With A Key Role In Parkinson’s Disease

Learn more about the potential of microRNAs as therapeutic targets being investigated for a number of different disease states.

Assessing End-To-End Drug Development Partnerships

As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.

A Human HTS Platform For Assessing Gastrointestinal Toxicity (GIT) Risk In Early Development

We review a solution for the need for human models of GI risk assessment that can be utilized for drug optimization in early development.

Mechanistic Chromatography Modeling

Mechanistic models make it possible to create computer simulations of chromatograms. You can test thousands of purification options in a few hours.

Embrace Molecule Complexity With Optimized Expression Technologies

Explore the needs of more complex candidates through case studies that demonstrate the range of expression capabilities across mammalian and microbial derived molecules.

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