GMP Ancillary Materials for Cell and Gene Therapy Manufacturing
Ancillary materials (AMs), also called raw materials in Europe, are components, reagents, and materials used in the manufacturing of cell, gene, and tissue-engineered (CGT) therapies but are not intended to be present in the final product formulation.
Identifying Oligonucleotide Impurities and Metabolites With High-Resolution Mass Spectrometry
With the rapid increase in the development of oligonucleotide therapeutics and gene therapies, workflows for the identification, characterization and quantification of full-length products, their impurities and metabolites, are critical.
A Successful Journey to Cell Therapy Manufacturing: From Research and Development to Lot-Release
Cell therapy is a transformative cancer treatment that utilizes genetically modified cells from a healthy donor or patient's own immune system to attack cancer cells, but manufacturing these cells represents a major challenge for the industry.
Bringing Life to PK Profiles – In Vivo-Relevance From an In Vitro Environment
In drug development, microphysiological systems (MPS) are utilized to develop in vitro biological models that can generate more physiologically- and human-relevant data.
Racing Against Time: Rapid, High-Throughput Discovery of Antibody Therapeutics for SARS-CoV-2
Vanderbilt University Medical Center researchers Robert Carnahan and Pavlo Gilchuk are attempting to compress the timeline for therapeutic antibody development, by integrating a series of advances in single-cell messenger RNA sequence analysis, bioinformatics, synthetic biology and high-throughput functional analysis.
How To Stop Good Pharmaceutical Formulations Going Bad
Selection of the appropriate techniques and assays, and their application in well-managed analytical programs, can simplify the process of deformulation and ensure a speedy route to market.