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Single Use Technologies - Are they sustainable? | Over more than two decades, the pharmaceutical industry has increasingly adopted single-use technologies primarily to simplify manufacturing and seemingly to reduce cost; however, the need to reduce environmental burden has a huge impact on these facilities. This session will focus on single-use technologies for gene and cell therapy facilities, while considering the impact on sustainability.
Our first presenter will investigate the impact of single-use with respect to proper cleaning, disposal, and handling, and how it relates to vaccine production including Industry 4.0 and implementation of the 6R's.
Our second presenter will discuss the unique nature of Advanced Therapy Facilities including the advantages and disadvantages of single-use and modular clean room technology as well as flexible manufacturing for gene and cell therapies.
Devices and Decontamination—Overcoming Challenges | Aseptic products are oftentimes a component part of a Combination Product. These aseptically filled present technical challenges that will be addressed in this session. Additionally, manufacturers are often tasked with utilizing legacy equipment…
Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry? | 2020 saw the commenting of the draft Annex 1, which included many changes to the 2017 version. In this session, we will cover the commenting process both from the ISPE and the PHSS perspective…
Regulatory and Industry Panel | The Regulatory and Industry Panel is one of the highlights of this conference. This session features questions and answers of the most daunting regulatory issues facing regulators and industry at this time…