Facilitating Biopharma Continuous Manufacturing

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Pharmaceutical TechnologyPharmaceutical Technology, Regulatory Sourcebook, March 2022
Volume 2022 eBook
Issue 1
Pages: 52-54

USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

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Rawpixel.com/Stock.adobe.com

Manufacturers, regulators, and other industry organizations are aiming to advance biopharmaceutical continuous manufacturing and to connect upstream and downstream into fully continuous processes. The United States Pharmacopeial Convention (USP), a nonprofit organization known for developing standards for quality, is actively involved in facilitating implementation of continuous manufacturing in the bio/pharmaceutical industry. Pharmaceutical Technology spoke with John Kokai-Kun, director, External Scientific Collaboration at USP about these efforts.

Read “Facilitating Biopharma Continuous Manufacturing” in Pharmaceutical Technology’s Quality and Regulatory Sourcebook Ebook.

Article details:

Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook
March 2022
Pages: 52-54

Citation

When referring to this article, please cite it as J. Markarian, “Facilitating Biopharma Continuous Manufacturing,” Pharmaceutical Technology’s Quality and Regulatory Sourcebook eBook (March 2022).

Articles in this issue
Common FDA 483 Observations for Combination Products
Common FDA 483 Observations for Combination Products
Facilitating Biopharma Continuous Manufacturing
Facilitating Biopharma Continuous Manufacturing
Warut/Stock.adobe.com – Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.
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How a Lack of Critical Thinking is Hindering Regulatory Compliance
How a Lack of Critical Thinking is Hindering Regulatory Compliance
A Method Validation Framework for Combination Products
A Method Validation Framework for Combination Products
Contextualizing Computer Validation
Contextualizing Computer Validation
Supply Chain Considerations for Ensuring Quality
Supply Chain Considerations for Ensuring Quality
DSCSA’s Next Big Hurdle
DSCSA’s Next Big Hurdle
Remote Inspections - Lessons Learned
Remote Inspections - Lessons Learned
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