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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

In addition to the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have also approved applications with CM for the production of solid oral dosage forms. End-to-end continuous processes flow from starting materials to finished dosage forms.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” Nature Communications 12, no. 5 , 13 , 27 , 32 1 US Food and Drug Administration. 7 June 2023.

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Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence

ISPE

Its Pharmaceutical Education & Research Center (PERC) is a US Food and Drug Administration (FDA)-registered, cGMP-compliant, single-source CRO equipped with the latest equipment and technologies, for most dosage forms, found in the pharmaceutical industry. You may unsubscribe from these ISPE communications at any time.

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Enabling Global Pharma Innovation: Delivering for Patients

ISPE

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation.

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