Implementing PAT

Muzzio's research group at Rutgers has been working with eight industry participants-including pharmaceutical manufacturers, equipment suppliers, and a contract development and manufacturing organization (CDMO)-on an US Food and Drug Administration-funded project to evaluate the RTD approach. &...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2023-03, Vol.35 (3), p.21-31
Main Author: Markarian, Jennifer
Format: Article
Language:English
Subjects:
Drug dosages
Interfaces
Manufacturing
Pharmaceuticals
Process controls
Quality control
Spectrum analysis
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Summary:Muzzio's research group at Rutgers has been working with eight industry participants-including pharmaceutical manufacturers, equipment suppliers, and a contract development and manufacturing organization (CDMO)-on an US Food and Drug Administration-funded project to evaluate the RTD approach. "By understanding the composition of the drug intermediate and/or final product, companies can reduce the number of failed batches and prevent significant waste, while simultaneously reducing costs and improving quality." Water does not interfere with Raman measurements, which is a significant benefit given the aqueous nature of many pharma applications, he adds. Effort must also be put into connecting the instrument to the data collection system and to developing robust models that can use these data to calculate critical quality attributes (CQAs).
ISSN:1753-7967