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
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Large-Scale LNP Process Conversions: The many hurdles of LNP scale-up and what to consider
May 12th 2025Lipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.
