Cynthia Challener on Muck Rack

Cynthia Challener

Verified
Burlington
As seen in: BioPharm International, ICIS Chemical Business, Pharmaceutical Technology, NewsBreak, ICIS News, BioProcess International Magazine, Pharma's Almanac, Cell & Gene, Pharmaceutical Outsourcing, Pharmaceutical Technology MX
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Articles

Data Integrity: Drivers, Challenges, and Key Program Elements

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By Cynthia Challener Verified
| Pharma's Almanac Verified
Key Takeaways: Data integrity also contributes to more efficient and effective manufacturing processes and is essential for enabling ethical and effective decision-making and assuring the development of safe and effective drugs. Failure to comply with data integrity regulations can also have serious consequences for drug makers, such as issuance of warning letters, imposition of sanctions and fines, import bans, required product withdrawals, and even plant shutdowns.
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Enabling the Commercialization of Peptide Therapeutics with Manufacturing Advances

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By Cynthia Challener Verified
| Pharma's Almanac Verified
Key Takeaways: Peptide therapeutics are being developed for many applications beyond treatment of cardiometabolic diseases and weight loss, including as antimicrobial therapies, anticancer treatments, and vaccines. Peptides are readily degraded in the body and typically have low oral bioavailability and poor membrane permeability.
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Exponential Advances in Protein Engineering

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By Cynthia Challener Verified
| Pharma's Almanac Verified
Key Takeaways: Advances in genetic engineering, x-ray crystallography techniques, and AI/ML-based computational modeling have led to great strides in therapeutic protein engineering. In addition to traditional random and rational design approaches for the improvement of existing proteins, de novo design to generate completely novel proteins is increasingly common.
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