PDA is excited to be returning to New York as the Premier Association Sponsor of INTERPHEX, the leading event to “Experience Science through Commercialization!”
While at INTERPHEX, be sure to take advantage of all PDA has to offer to help advance your career and identify solutions to improve your company’s processes. Staff will be available at the PDA Booth (Booth 1653) in the Exhibit Hall to discuss the PDA tools and resources you can use to improve your processes and advance your career. Stop by to learn how PDA can help you achieve more through events, training courses, technical publications, standards, and more!
Continuing a years-long tradition, PDA will also be presenting two informational roundtables on Stage 1 in the Exhibit Hall during the Show. Don’t miss these exciting talks on two hot industry topics:
Tuesday, May 24
11:15 a.m. – 12:00 p.m., Stage 1
Formulation and Process Development of Lipids, Polymers, and Nanoparticle Drug Products
Alex Aust, Aust Business Solutions, LLC
Roundtable Description: The selection and manufacture of functional excipients is required to assemble the nanoparticles that are being used to deliver various payloads (e.g., mRNA, pDNA) for genetic therapeutics and more. In this presentation, we will dive into how these lipids and polymers are ultimately chosen based upon their characterization data, and then we will move into how the formulations are optimized, scaled up, and eventually moved into the cGMP environment to make finished drug product. From formulation to patient, we will examine the major unit operations and the data required to enable the next phase. With Lipid Nanoparticles (LNPs) set as the default drug delivery vehicle for mRNA, we will discuss why this is and other nanoparticle/nanocarrier alternatives, such as: exosomes, polymeric nanoparticles, suspensions, emulsions, and more.
Wednesday, May 25
11:15 a.m. – 12:00 p.m., Stage 1
Comparability Study Considerations for Cell Therapies
Michael Blackton, SVP, Cell Therapy Manufacturing, Nurix Therapeutics
Roundtable Description: Cell therapies, while inherently complex, have a great potential to advance quickly through clinical trials, and because of this, it is important to apply lifecycle requirements much earlier than for other biologic products. Because of the inherent complexity surrounding these therapies, it can be a challenge for drug developers to establish comparability plans that address regulatory requirements. One of the keys to ensuring success is a defendable, scientifically justified demonstration that process changes are applied in a controlled manner that preserves the integrity of the product.
In this session, we will explore what comparability means for cell therapy, the regulatory requirements to help us ensure success, and strategies for ensuring a clear path to approval for these products. In the context of fast track success, it is important to establish good science so that our patients can benefit as soon as possible.
Check the online Technical Conference and Events Schedule for more details!
All PDA members can take advantage of FREE Registration to INTERPHEX 2022! Please email [email protected] for the discount code!