Gene & Cell Therapy Testing

2 03, 2023

Avance Biosciences™ licenses SeQure Dx’s GUIDE-seq off-target NGS analysis technology

2024-08-09T18:08:43+00:00

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...

Avance Biosciences™ licenses SeQure Dx’s GUIDE-seq off-target NGS analysis technology2024-08-09T18:08:43+00:00
21 02, 2023

Weill Cornell study demonstrates safety of intravenous administration of an AAV8 gene therapy

2024-07-13T13:31:10+00:00

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...

Weill Cornell study demonstrates safety of intravenous administration of an AAV8 gene therapy2024-07-13T13:31:10+00:00
14 02, 2023

mRNA Analytical Development Summit – 2023

2025-03-14T19:45:40+00:00

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...

mRNA Analytical Development Summit – 20232025-03-14T19:45:40+00:00
7 02, 2023

FDA clears Sana Biotechnology’s CAR T Therapy IND application for patients with B-cell malignancies

2024-07-11T15:39:52+00:00

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...

FDA clears Sana Biotechnology’s CAR T Therapy IND application for patients with B-cell malignancies2024-07-11T15:39:52+00:00
13 12, 2022

ASGCT Members Provide Recommendations During FDA Liaison Meeting

2024-07-13T13:33:00+00:00

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...

ASGCT Members Provide Recommendations During FDA Liaison Meeting2024-07-13T13:33:00+00:00
6 12, 2022

CG Oncology advancing clinical-stage urologic oncology immunotherapy pipeline

2022-12-06T19:23:30+00:00

Company files its first Investigational New Drug application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis. Kyverna’s therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate...

CG Oncology advancing clinical-stage urologic oncology immunotherapy pipeline2022-12-06T19:23:30+00:00
28 11, 2022

Gene Therapy Analytical Development Summit – 2022

2025-03-14T19:53:44+00:00

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...

Gene Therapy Analytical Development Summit – 20222025-03-14T19:53:44+00:00
22 11, 2022

Quantification of On/Off-Target Gene Editing

2024-07-10T19:27:53+00:00

Quantitative analysis of gene editing is now an essential step in getting regulatory approval of gene editing-based therapies. But designing and validating assays for on/off-target editing analysis and building an internal team to perform them can be costly and inefficient...

Quantification of On/Off-Target Gene Editing2024-07-10T19:27:53+00:00
9 11, 2022

CHOP Study Offers Proof of Concept for Treating Pediatric Brain Tumors with Immunotherapy

2024-07-13T13:31:55+00:00

Although immunotherapy has revolutionized the treatment of many blood cancers, the field has encountered challenges developing similar treatments for solid tumors. When it comes to pediatric brain tumors, which are the leading cause of cancer death in children, challenges include...

CHOP Study Offers Proof of Concept for Treating Pediatric Brain Tumors with Immunotherapy2024-07-13T13:31:55+00:00
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