Remove 2022 Remove Dosage Remove Process Improvement
article thumbnail

Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Trudy Patterson.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). 7 International Society for Pharmaceutical Engineering. ISPE Regulatory. Langer, and R. Pharmaceutical Engineering 42 no. Robinson, G.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). 7 International Society for Pharmaceutical Engineering. ISPE Regulatory. Langer, and R. Pharmaceutical Engineering 42 no. Robinson, G.

article thumbnail

Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. Reader note: This article was originally submitted to Pharmaceutical Engineering® in January 2022. 5 (May 2022): 1232–1244. 5 (May 2022): 1232–1244. Trudy Patterson. Regulatory Landscape for Raw Materials: CMC Considerations. Jacqueline E.

article thumbnail

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. 3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24. 5 October 2022. 18 May 2022. 6 (2022):215. The fit-for-purpose and reduced-size POD units promote green manufacturing.