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Avance Biosciences™ licenses SeQure Dx’s GUIDE-seq off-target NGS analysis technology
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...
Quality Assurance of E. coli Cell Banks used in Biopharmaceutical Production
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...
Weill Cornell study demonstrates safety of intravenous administration of an AAV8 gene therapy
Researchers report on the safety of a gene therapy to treat the common autosomal recessive hereditary disorder alpha 1-antitrypsin (AAT) deficiency in a new article in the peer-reviewed journal Human Gene Therapy. In ATT deficiency, neutrophil proteases destroy the lung parenchyma, the portion of the lungs...
FDA clears Sana Biotechnology’s CAR T Therapy IND application for patients with B-cell malignancies
The goal of the hypoimmune platform is to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune platform includes disruption of major...
Scientists develop novel mRNA delivery method using extracellular vesicles
In the study, published in Nature Biomedical Engineering, researchers from MD Anderson Cancer Center use EV-encapsulated mRNA to initiate and sustain collagen production for several months in the cells of photoaged skin in laboratory models. It is the first therapy to demonstrate this ability and represents a proof-of-concept for deploying the EV mRNA therapy...
ASGCT Members Provide Recommendations During FDA Liaison Meeting
ASGCT held its fifth annual liaison meeting with FDA CBER’s Office of Tissues and Advanced Therapies (OTAT) on Nov. 14, 2022. A group of Society leaders and members gave two presentations to FDA on significant topics in the field, followed by a presentation from FDA. Dr. Keith Wonnacott, ASGCT’s Regulatory Affairs Committee Chair, chaired the meeting and moderated discussion...