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eChalk Talk: CMC Bioanalytical Control for ATMPs-Challenges and Strategies

Sr. Director of CMC Bioanalytical Services, Jeff Patrick, PhD, and Scientific Officer, Michelle Miller, PhD, provide an overview of considerations in the development and lifecycle of assays for CMC control strategies for ATMPs. Watch as they discuss case studies that highlight the development and phase-appropriate validation of tests for potency, purity/impurity, quantity, and identity of ATMP drug products.
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Webinar

eChalk Talk: Bioanalytical Strategy for Immunogenicity Assessment of ATMPs

Due to the complexity of ATMPs, it is critical to evaluate the potential immune responses to these novel drugs as it can impact both safety…

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Webinar

eChalk Talk: Bioanalytical Strategy for PK Assessments of ATMPs

The emergence of advanced therapeutic medicinal products (ATMPs), such as cell and gene therapies, has led to the increased utilization of specialized technology platforms in…

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Webinar

Challenges and strategies for the bioanalysis of protein therapeutics and biomarkers by LC–MS/MS

Bioanalysis of proteins by LC–MS/MS is a well-established technique in drug discovery and development. LC–MS/MS has gained popularity as a complementary approach to ligand-binding assays…

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Case Studies

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Economical Preclinical PK Immunoassay

A start-up biotechnology company developed a library of constructs having the Fc portion of human IgG and their warhead denoted as X for confidential reasons. Fc-X fusion protein drug candidates were distinguished by amino acid substitutions in the warhead moiety, changes that were predicted to affect PK characteristics.
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Case Study

Increasing Assay Sensitivity

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Case Study

PK Assay For Therapeutic Antibody Quantification In Sodium Heparin Plasma

While conducting the pre-validation stage of a pharmacokinetic assay study, a sponsor asked BioAgilytix to develop a method for analyzing a specific therapeutic antibody when…

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Case Study

Use Of MSD-ECL In Support Of Multiplex Biomarker Study

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Blog

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CMC Analytical Control Strategies for Drug Development

CMC (chemistry, manufacturing, and controls) is a term used when drug developers define their investigative drug substance, establish manufacturing methods for…
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Blog

Large Molecule Bioanalysis using LC/MS

Introduction to Large Molecules Therapeutics are an ever-evolving landscape of modalities which range in complexity but can be grouped into two broad categories: small molecules…

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Blog

LC/MS Applications in Drug Development

Basic Principles of LC/MS Methods Liquid Chromatography-Mass Spectrometry (LC/MS) is a technique that involves the physical separation of target analytes followed by their mass-based detection.…

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Blog

PCR as a Bioanalytical Tool for Gene and Cell Therapy

The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool for gene and cell therapy. …

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Molecular Moments Podcast 

Podcast

[EPISODE 27] CEO of BioAgilytix Davide Molho,  Discusses Passion, Innovation, and the Future of the CRO Industry

In this episode of Molecular Moment, host Jim McNally, Ph.D., welcomes Davide Molho, DVM, the new CEO of BioAgilytix, to discuss his background, interests, and…

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Podcast

[Episode 26] Drs. Shashank Gorityala, Ben Nie, and Amanda Hays talk LC/MS bioanalysis, platforms, matrices, workflows, and regulations

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Podcast

[EPISODE 25] Adam Stasio Talks Large Data Sets, Breaking Down Problems, and Tech-Driven Solutions

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Podcast

[EPISODE 24] Dr. David Berkowitz Talks Enzymes, Radiation, And The Lincoln Marathon

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Science in 60 Videos

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What is an ADA assay cut-point and how is it determined?

In this episode of “Science in 60” Matt Moore delves into the fascinating world of ADA assay cut-point and how it’s established. ADA assay cut-point is…
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Science in 60

What is Luminex and How Does it Work?

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Science in 60

How Do You Use MSD U-Plex Assay Technology For Biomarker Multiplexing?

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Science in 60

What Are Drug-Drug Interactions With Respect To Medicines?

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