Avance Biosciences™ is a world-leading CRO specializing in GLP & GMP compliant biological assay development, assay validation, and sample testing services in support of biological drug discovery, development and manufacturing...
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...
Sotatercept, a soluble fusion protein comprising the extracellular domain of activin receptor type IIA linked to the Fc portion of human IgG1, is a first-in-class activin signaling inhibitor under development for the treatment of pulmonary arterial hypertension (PAH). We evaluated antidrug antibody (ADA) development and determined the effects of immunogenicity on the pharmacokinetics (PKs), efficacy, [...]
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...
INTRODUCTION: 9MW1411 is a humanised monoclonal antibody against Staphylococcus aureus alpha-toxin. The safety, pharmacokinetics (PK) and immunogenicity of 9MW1411 should be characterised in humans before further clinical development. METHODS: A single-centre, randomised, double-blind, placebo-controlled phase I clinical study was conducted in humans for the first time. A total of 42 healthy Chinese subjects were randomised [...]
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…
Shiga toxin-producing Escherichia coli infections are difficult to treat due to the risk of antibiotic-induced stress upregulating the production of toxins, medical treatment is consequently limited to supportive care to prevent the development of hemolytic uremic syndrome (HUS). Here, we introduce a potentially therapeutic humanized mouse monoclonal antibody (Hu-mAb 2-5) targeting Stx2a, the most common [...]
