article thumbnail

Considerations for a Decentralized Manufacturing Paradigm

ISPE

Pharmaceutical Processing World. 1 May 2015. Nature Communications 12, no. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Journal of Biotechnology 213 (2015):120–30. Rockville, MD: US Pharmacopeial Convention, 2015. “Modular Manufacturing.” 12 April 2016.

article thumbnail

Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. You may unsubscribe from these ISPE communications at any time.

article thumbnail

Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). October 2015. You may unsubscribe from these ISPE communications at any time. 7 An integrative (vs. Accessed 3 December 2022. www.ceguide.org/ 2 United Nations. link] 3 Peasoup. 7 November 2022.