Potency testing is an essential part of developing cellular and gene therapy (CGT) products. The US Food and Drug Administration (FDA) requires sponsors for Investigational New Drug (IND) and Biologics License Application (BLA) to provide in vitro or in vivo data to demonstrate the potency of the drug product...
Protein expression analysis is a critical process for researchers in the life sciences industry. The ability to accurately and reliably measure protein expression and distribution is essential for understanding the underlying biological mechanisms of disease and for developing effective therapeutic interventions...
Cell and gene therapy drug products represent a rapidly growing field in the development of new treatments for a wide range of diseases. These therapies have the potential to revolutionize medicine by offering cures rather than just managing symptoms. However, with this potential comes unique challenges, particularly with regard to biodistribution testing...
Non-clinical and clinical studies that evaluate pharmacokinetic (ADME) and toxicology characteristics are essential to determine cellular and gene therapy (CGT) product safety and efficacy. Studies on gene vector and transgene biodistribution (BD), gene expression, protein expression, viral shedding, vector integration...
Gene editing has the potential to transform the lives of patients with previously untreatable conditions, offering hope for a better future. As the technology continues to advance, it is likely that we will see more breakthroughs in this field in the coming years, bringing us closer to a world where rare diseases are...
Avance Biosciences™ (Avance), a leading CRO that provides GLP/CGMP-compliant biological testing services that aid drug development and manufacturing, announced today that it has signed a licensing agreement with SeQure Dx, a cutting-edge gene-editing diagnostics company...
The use of E. coli cell banks poses some challenges and requires careful attention to quality control and quality assurance to ensure that the cells are of the highest quality and free from contamination or genetic mutations. Testing may include identity, purity, viability, characterization, and stability testing...
Ensure the Success of Your Biological Drug Development - Avance Provides Assays to Support your Biopharmaceutical Development & Manufacturing - Avance Biosciences™ is a world-leading CRO specializing in GLP & GMP compliant biological assay development, assay validation, and [...]
With several years of experience supporting a world-renowned mRNA COVID-19 vaccine company with raw material and drug substance release, Avance Biosciences™ is well-positioned to provide industry-leading assay design, validation, and sample testing services that advance our clients’ mRNA therapeutic...
Avance offers a broad range of assay development services, including assay design, assay validation, sample testing, and technology transfer under GLP compliance to support IND-enabling and clinical studies. With decades of experience helping gene and cell therapy companies, Avance Biosciences™ has the...
