Understanding Excipient Quality and Impact on Formulation

November 4, 2020
BioPharm International Editors

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

The recent discovery of probable carcinogens in widely used APIs triggered a wave of drug recalls, increased regulatory oversight, and new testing procedures. Advanced analysis of excipients may reveal previously unknown ingredients; however, such a discovery prompts the need for better understanding of excipient components, the source and safety profiles of the materials, and the role they play in drug performance.

A panel discussion by experts from the excipient industry will address the importance of excipient characterization, challenges with ensuring an adequate supply of quality materials, and the potential for novel excipients. The Editors’ Series session, Excipients Update: Formulation, Supply, and Quality—organized and moderated by the editors of Pharmaceutical Technology—is scheduled for Nov. 11, 2020, 1:30 pm EST during the 2020 Bio/Pharma Virtual Congress.

The online Bio/Pharma Virtual Congress features panel discussions organized and moderated by the editors of Pharmaceutical Technology and BioPharm International magazines, sponsored technical sessions, a Virtual Exhibit Hall where visitors can chat in real-time with exhibitors, technical posters, and networking opportunities. Download the agenda (PDF).

The Excipients Update panel discussion will feature commentary from Nigel Langley, global technology director, Pharma Solutions, BASF Corporation; David R. Schoneker, president/owner/consultant, Black Diamond Regulatory Consulting, LLC; and Joseph Zeleznik, technical product manager, IMCD US. The panel is part of the Formulation track at the Virtual Congress; other formulation topics include formulations for injectable drugs, early development screening strategies, and assessing drug–device compatibility.

Registration for the day-long event (8:30 am–4 pm EST) is free to professionals involved in the development and manufacture of bio/pharmaceuticals.

Insight on the pandemic, bio/pharma’s response, and more

The COVID-19 pandemic’s impact on bio/pharmaceutical development and manufacturing, availability of crucial supplies, maintaining GMP compliance, and remote monitoring of manufacturing processes are other topics that will be discussed by industry experts during the 2020 Bio/Pharma Virtual Congress.

During a keynote panel discussion on Nov 11, 2020, 9 am EST, Bio/Pharma Industry—Beyond Politics and the Pandemic, representatives from industry organizations, will discuss bio/pharma’s response to the pandemic and the corresponding scrutiny and political pressure, as well as the short-, medium-, and long-term implications for bio/pharma development and manufacturing.

Dosage Forms Trends
How have biopharma companies responded and adjusted to pandemic issues? What lessons learned under fire may lead to more effective and efficient bioprocessing practices going forward? Eric Langer, managing partner, BioPlan Associates, Inc, shares research and expert insight in Delivering on the Promise: Overcoming Biopharma Development and Manufacturing Challenges, Drug Dosage Form track, Nov. 11, 2020, 10 am EST.

Manufacturing Trends
New technologies, such as artificial intelligence and machine learning, are being employed by bio/pharma manufacturers to collect and analyze large amounts of process data in real-time. An expert panel will discuss how this technology can be employed to optimize bio/pharma manufacturing and predictive maintenance during the Editors’ Series session, Technology Advances in Process Operations on Nov. 11, 2020, 11:30 am EST.

Bio/Pharma Industry Challenges
A panel discussion—A “New Normal” for Quality Practices—will reviewquality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes, and lessons learned going forward. The panel, part of the Bio/Pharma Industry Challenges track, is scheduled for Nov. 11, 2020, 1:30 pm EST.

To learn more about the 2020 Bio/Pharma Virtual Congress, download the agenda (PDF).

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Development | Formulation | Excipients