Continuous Manufacturing for Rapid Process Development
Keynote SeriesPharmaceutical Technology and BioPharm International are sponsoring a Keynote Series session on strategies and innovations to reduce drug shortages and improve availability of medicines on the INTERPHEX 2016 Exhibit Hall Innovation Stage. Admission is free to any attendee with an exhibit hall pass.
Wednesday, April 27
1:30–3:15 pm
Strategies and Innovations to Reduce Drug Shortages and Improve Availability of Medicines
Aging facilities and equipment, inadequate operator training, a lack of quality control, tighter regulatory enforcement, and business decisions to eliminate unprofitable product lines contribute to ongoing shortages vital drug products. In this session, industry thought leaders will identify triggers for drug shortages, methods to avoid production line shutdowns and update facilities, and innovative industry efforts to fulfill demand for needed therapies. A Q&A session will follow the presentations.
2:30-3 pm
Continuous Manufacturing for Rapid Process Development
In recent years the pharmaceutical industry has begun to adopt continuous manufacturing technology for the manufacture of traditional solid dosage forms. With this we have seen numerous benefits of the technology come to light including lower cost expedited development due to the ability to develop at scale. Many early adopters have reported on savings in time and materials that more than compensate for the capital required to transition to continuous as compared to a new batch operation. These savings in time and materials allow for more detailed investigations of design space and more robust development even for breakthrough therapies. More recently, US government agencies have begun to investigate continuous as a methodology for developing solid dosage products and processes needed for national security. This presentation will outline some of the new approaches being taken in this space and the benefits that will result.
Speaker: Douglas B. Hausner, PhD, Rutgers University/C-SOPS
To register: http://www.interphex.com/pharmtech
Other presentations in this session:
1:30–2 pm
An Interdisciplinary Approach to Address Drug Shortages
2-2:30 pm
BARDA Innovation Initiatives in Medical Countermeasure Manufacturing
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Your Ultimate Guide for CMC Testing Support for Gene and Cell Therapy
November 21st 2024Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.
