iSpeak Blog

The ATMPs - Autologous Cell Therapy Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use. This Guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current process/facility attribute alignment and how that changes in the ATMP space.


 

News & Press Releases
28 January 2022
ISPE announced Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy (OSTP), Executive Office of the President, as a confirmed keynote for the 2022 ISPE Facilities of the Future...
24 February 2022 - 24 February 2022
ISPE Australasia Affiliate and PDA Australia Chapter are proud to present a joint forum: Medical Technology, Biotechnology and Pharmaceutical (MTP) Industry 4.0 Forum About the event The ISPE Australasian Affiliate and PDA Australia Chapter are...
iSpeak Blog

Over the past decade, companies worldwide have faced increased scrutiny from consumers, investors, and regulators over how they treat the environment. They are questioned about where and how they source raw materials, the packaging they use, power consumption levels, and waste generated. Many companies understand these concerns and have taken active steps to be sustainable. Building industry...

This instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An....
This instructor led course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and....
News & Press Releases
21 January 2022
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) . This Guide was written to meet changing industry practices, as global...
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Historically, industrial manufacturing has advanced from mechanization to mass production and then to automation/computerization. The next phase of manufacturing (referred to as Industry 4.0) involves the integration of...
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