Understanding Polymorphism to De-Risk Drug Development
Overview: Oligonucleotides are an emerging class of DNA and RNA therapeutics that address a number of unmet medical needs. As with many biopharmaceuticals, the complex structure of oligonucleotides makes their large-scale synthesis both challenging and imperfect.
A number of impurities are generated during manufacturing, many of which are hard to identify using available analytical methods. Furthermore, the use of chemical modifications and formulations that expand the functionality and delivery capabilities of these therapeutics pose additional analytical challenges and potential risks.
As a result, the need for analytical methods that can determine the identity, purity, strength and stability of therapeutic oligonucleotides is critical for companies looking to meet the FDA’s Chemistry, Manufacturing, and Control (CMC) expectations.
In this webinar you will learn:
- Review the definitions of drug solid form, polymorphism, crystallinity, and amorphicity.
- Understand the physical nature of polymorphism and the techniques used to find polymorphs, salts, and cocrystals.
- Develop an appreciation of the importance of profiling polymorphism in drugs for the following factors:
- As a key component of selecting the proper solid form for development
- As a necessary inclusion in key regulatory filings
- As an asset for intellectual property filings, which can prevent competitors from legally formulating your drug using a polymorph not under patent protection.
Who should attend:Scientists, managers, and regulatory professionals involved in small molecule drug development, from early-stage preformulation through late-stage approval.
Steven Johnston, PhD
Director Pharmaceutical Development
Pace Analytical Life Sciences