Excipients step into the spotlight in this podcast series, addressing novel excipients, the role of heavy metals, pricing, and more.
Sponsored By:
In May 2010, Pharmaceutical Technology moderated a Speakers’ Roundtable at the ExcipientFest-Americas and IPEC Regulatory Conference in San Juan, to discuss excipient use and regulation. On the panel were: FDA’s Rosa Motta, USP’s Catherine Sheehan, IPEC and Pfizer’s Janeen Skutnik, IPEC and Huber Engineered Materials’ Dale Carter, Dow Wolff Cellulosics’ William Busch; Amgen and Rx-360’s Eric Berg, BASF’s Ranga Velagaleti, Anchen’s Sherry Ku, and Moderator Angie Drakulich of Pharmaceutical Technology.
This portion of the roundtable provides an introduction to the topic and to the panelists. Plus, the panel discusses recnt changes to the excipient industry, FDA's current expectations regarding excipient understanding and control, and supply-chain challenges, including the ability and expectation to audit every supplier.
Panelists address the IPEC novel excipient evaluation procedure, including USP's role in the pilot program, and FDA's take on the use of novel excipients.
Panelists address the proposed USP heavy metals revisions, the ICH expert working group on elemental impurities, and the controversy regarding supplier qualification versus material price.
In this final portion of the roundtable, audience members question the panelists about the use of--and FDA expectations for--paper audits, expanding the Inactive Ingredients Database, and more.
Read the print version of this roundtable, a Q&A report, that appeared in the June 2010 issue of Pharmaceutical Technology.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
May 30th 2025In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
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.