In a groundbreaking development that could revolutionize organ transplantation, eGenesis, a biotechnology company dedicated to addressing the global organ shortage crisis, has announced the successful transplantation of a genetically engineered porcine kidney into a living human recipient...
This comprehensive guide explores the essential tools of quantitative PCR (qPCR) and digital droplet PCR (ddPCR) in the biopharmaceutical industry, offering invaluable insights into their applications, strengths, and limitations. Download now to stay ahead of the curve in pharmaceutical research and development...
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 [...]
We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated Society of Toxicology Annual Meeting in Salt Lake City, and we cordially invite you to join us! More than 5,000 toxicologists and those working in areas related to toxicology will share the latest science and technology...
The guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety...
In a landmark move, the FDA has initiated the Collaboration on Gene Therapies Global Pilot (CoGenT), signaling a significant leap toward worldwide collaboration in the field of gene therapy. This pilot aims to enable concurrent collaborative reviews of new gene therapy applications with global regulators…
In this draft guidance, the FDA emphasizes that potency assays and their corresponding acceptance criteria should be designed to make meaningful contributions to potency assurance by reducing risks to product potency. They provide illustrative examples of approaches to potency assay development that are...
In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has approved two revolutionary treatments, Casgevy and Lyfgenia, marking a significant milestone in the field of gene therapy. These therapies represent the first-ever cell-based gene treatments for sickle cell disease (SCD) in patients...
In a landmark decision that could reshape the landscape of medicine and treatment, the United Kingdom has granted approval for the first-ever CRISPR therapy, Casgevy. This groundbreaking development marks a significant stride in the field of genetic medicine and opens up new possibilities for treating a range of...
We are excited to announce that Avance Biosciences™ will be attending the highly anticipated Gene Therapy Analytical Development Summit and the mRNA Assay Development Summit, and we cordially invite you to join us! As a leader in development and validation of assays for advanced therapies...
