All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

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Automate Aseptic Filling: Closing the System at Full Modularity

By Jonathan Haider

November 6th 2024

Shifting to automated, closed modular manufacturing systems is growing increasingly crucial for biopharmaceutical production.

factory of the pharmaceutical industry. pills on the conveyor | Image Credit: © Mike Mareen - © Mike Mareen- stock.adobe.com

The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical Manufacturing

By Donald Singer
Tony Cundell

August 11th 2024

The growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.

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Novo Nordisk Aims to Invest $4.1 Billion to Expand Manufacturing Capacity in US

By Feliza Mirasol

June 27th 2024

This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.

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Streamlining Aseptic Processes through Automation

By Felicity Thomas

June 13th 2024

Leveraging automation advancements can help improve efficiency in aseptic processing and speed up commercialization of critical drug products.

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