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

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…

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.…

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. …

An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive into cell therapy programs. If…

An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of genetic disorders at the DNA…

This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry for bioanalysis, part 2 investigated…

As we continue our blog series on flow cytometry, we’ll now dive into how this powerful capability supports multiple types of cell therapies. If you…

Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can analyze multiple characteristics of cells…

Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing costs while providing patients with…