Pharmacokinetic Assay: Ligand Binding Assays for Large Molecules – Method Development and Validation
Wednesday, April 14, 2021
11:15am – 11:45am ET
Register Now!
Pharmacokinetic assay should deliver reliable and accurate data when used in non-clinical and clinical trials. The talk will cover what you should consider when developing a large molecule ligand-binding assay, and the validation parameters needed to produce a valid assay for regulatory submissions.
Speaker:
Marianne Scheel Fjording, Ph.D.
Unique Challenges of Implementing an ELISPot Assay in a Regulated Environment: A Case Study on SARS-CoV-2 Vaccine Development
Wednesday, April 21, 2021
11:15 am – 11:45 am ET
Register Now!
The unprecedented and rapid spread of SARS-CoV-2 into a global pandemic, combined with its high mutation rate, has motivated the need for a robust vaccine that can stimulate broad protective immunity. ELISpot assays have emerged as powerful tools in vaccine development due to their ability to measure antigen-specific cellular immunity in a highly sensitive and high throughput manner. While these assays have long been employed in the academic research setting, the implementation of ELISPot assays in a regulated environment is relatively new. There are some unique challenges in implementing ELISpot assays in a regulated environment due to the lack of reference materials or gold standards and due to the lack of regulatory guidance.
Here we present a framework for the validation of an interferon-gamma ELISpot assay in a regulated environment. In the recent context of a worldwide effort to develop a vaccine candidate against SARS-CoV-2 and their variants, we also demonstrate the utility of the assay to support robust SARS-CoV-2 vaccine development.
Speaker:
Rafiq Islam, MS
Confidently Detect and Quantify Trace Nitrosamine (NDMA) Impurities in Drug Products
Tuesday, May 11, 2021
11:15 am – 11:45 am ET
Register Now!
Recently, angiotensin receptor blocker (ARB) and Zantac drug products were recalled due to NDMA contamination. Mutagenic impurities such as NDMA pose significant risk to patient’s health, even in trace amounts. Thus, USFDA and other regulatory agencies have enforced even more stringent regulations for NDMA evaluation in drugs. The regulatory agencies around the world have published validated analytical testing methods to detect and quantify NDMA in ARB and Zantac drugs. In this presentation, we will cover the USFDA regulations for the detection of nitrosamines. We will also review the LC/TQ based analytical method for the identification and quantification of NDMA at very low detection limits.
Speaker:
David Weil, Ph.D.
Routine Accurate Mass Detection for Forced Degradation Studies
Wednesday, May 12, 2021
11:15 am – 11:45 am ET
Register Now!
The best way to avoid costly surprises down the road during drug manufacturing is to apply the right methodologies from the beginning, to accurately identify and control impurities during drug development. Part of this process takes place at the formulation stage, where forced degradation studies are carried out to develop analytical procedures that will be implemented in a regulated environment during manufacturing.
What are the traditional methods and techniques, both in screening and characterization? How can routine accurate mass detection with streamlined software applications be used to collect more insightful data at this stage, to shape control strategies for QC analyses, and support regulatory filings? In this eChalk Talk, we will look at how a French CRO successfully implemented these new technologies to improve analytical development services for their customers.
Speaker:
Chris Henry
Balance Study Design for Anti-Drug Antibody Cut Point Analysis
Wednesday June 2, 2021
11:15 am – 11:45 am ET
Register Now!
Balance design and its requirement in the successful establishment of an Anti-Drug Antibody (ADA) cut point is a hot button topic currently. Although it is stated directly in the FDA 2019 guidance that “balance study designs should be used for cut-point determination”, this requirement is not strictly followed within the industry. Many reasons are reported for this lack of adherence to this recommendation the most prevalent one being that this approach is more of a “nice to have” rather than a “must have” for appropriate setting of a cut point during validation. The goal for this e-Chalk Talk is to walk through a general overview of what a balance design is and why it is truly needed to successfully set a cut point for ADA determination.
Speaker:
Stephanie Pasas-Farmer, Ph.D.
