Voices of Biotech
Podcast: MilliporeSigma says education vital to creating unbreakable chain for sustainability
MilliporeSigma discusses the importance of people, education, and the benefits of embracing discomfort to bolster sustainability efforts.
- Sponsored Content
- Manufacturing
BPI Contributor
December 3, 2019
20 Min View
Date: Dec 3, 2019
Duration: 20 Min
Sponsored by WuXi Advanced Therapies
This webcast is no longer available.
This webcast features: Dr. Sherry Parker, Senior Director, Regulatory Toxicology and Technical Services, WuXi AppTec
Extractable and leachable studies of single- and multi-use manufacturing components should be followed up with a chemical safety assessment to understand the chemical risks based on the toxicity of the chemical, the dose and the exposure duration of the drug product, and the patient population for its intended use. This case study will illustrate considerations when conducting a chemical safety assessment, the pitfalls of having unknown chemicals in your chemistry reports, options for mitigating potential risks, and the importance of using toxicologists skilled in these assessments.
Key Lessons Learned:
Not all chemicals are equal when it comes to safety risks.
Unknown chemicals can cause unnecessary challenges in the safety assessment.
Safety assessments should be conducted by qualified professionals.
This webcast is no longer available.
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