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News & Events

24 05, 2022

UMass Chan researchers describe innovative next-gen sequencing technique for evaluating manufacture of vectors for gene therapy

2024-07-13T13:34:56+00:00

A paper from the Horae Gene Therapy Center at UMass Chan Medical School may settle a longstanding debate about how to best manufacture adeno-associated virus (AAV) vectors for gene therapy. The paper, published online in the journal Human Gene Therapy, describes using AAV genome population sequencing (AAV-GPseq) to explore the genomes of vectors produced by two [...]

UMass Chan researchers describe innovative next-gen sequencing technique for evaluating manufacture of vectors for gene therapy2024-07-13T13:34:56+00:00
10 05, 2022

FDA issues new draft guidelines on genome editing and CAR-T therapy

2024-07-13T13:28:34+00:00

On March 15th, 2022 the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The draft guidance, “Human Gene Therapy Products Incorporating Human Genome Editing,” is intended to provide recommendations to sponsors [...]

FDA issues new draft guidelines on genome editing and CAR-T therapy2024-07-13T13:28:34+00:00
5 05, 2022

Avance Biosciences™ Announces Validation of New Facilities, Expansion of Mammalian Cell Culture and Protein Analysis Services

2024-07-10T19:29:54+00:00

HOUSTON, May 5, 2022 /PRNewswire/ -- Avance Biosciences™, a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services supporting biological drug development and manufacturing, announced today completion of move-in and validation of an additional 26,000 square feet of laboratory space acquired in the past year. Avance also announced expanded offerings of validated [...]

Avance Biosciences™ Announces Validation of New Facilities, Expansion of Mammalian Cell Culture and Protein Analysis Services2024-07-10T19:29:54+00:00
4 05, 2022

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients

2024-07-10T19:30:59+00:00

Graphite Bio is a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision gene repair to develop therapies with the potential to treat or cure serious diseases. The FDA has just granted Fast Track Designation to GPH101 for the treatment of sickle cell disease (SCD). GPH101 is an investigational next-generation gene-edited autologous [...]

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients2024-07-10T19:30:59+00:00
3 02, 2022

Mission Bio Transfers First Tapestri GMP-Ready CGT Assay to Avance Biosciences™ for Cell-Based Therapies

2024-08-09T18:09:35+00:00

GMP-compliant test for transduction efficiency marks a key milestone for Tapestri’s ability to power single-cell analysis in clinical trial settings for cell & gene therapies SOUTH SAN FRANCISCO, February 2, 2021 -- Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced today the first tech transfer of a clinical trial-ready cell [...]

Mission Bio Transfers First Tapestri GMP-Ready CGT Assay to Avance Biosciences™ for Cell-Based Therapies2024-08-09T18:09:35+00:00
16 02, 2021

Avance Biosciences™ Expanding Houston Campus

2024-07-10T19:33:13+00:00

HOUSTON, Feb. 16, 2021 /PRNewswire/ -- Avance Biosciences™, a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services supporting biological drug development and manufacturing, announced today that its Houston facility, which successfully passed an inspection by the U.S. Food and Drug Administration in Oct 2018, is undergoing major expansion to handle rapidly growing demand for their services. [...]

Avance Biosciences™ Expanding Houston Campus2024-07-10T19:33:13+00:00
5 02, 2021

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic

2024-07-10T19:48:09+00:00

The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight. Cellular therapy products include cellular immunotherapies, cancer vaccines, [...]

FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic2024-07-10T19:48:09+00:00
7 12, 2020

Avance Biosciences™ Recognized as Top 10 Genomics Solutions Company

2022-05-05T13:21:09+00:00

Pharm Tech Outlook, a highly respected pharmaceutical/biotech industry magazine, has recognized Avance Biosciences™ as a top 10 Genomics Solutions Company for 2020. Genomic technologies and their usage have seen extensive growth in the past decade. Over the years, these technologies have evolved significantly and can now be used [...]

Avance Biosciences™ Recognized as Top 10 Genomics Solutions Company2022-05-05T13:21:09+00:00
16 10, 2020

MASS General researchers show ddPCR brain tumor liquid biopsy assay has tenfold improvement in sensitivity over any prior assay

2024-07-13T13:35:57+00:00

Genetic mutations that promote the growth of the most common type of adult brain tumors can be accurately detected and monitored in blood samples using an enhanced form of liquid biopsy developed by researchers at Harvard-affiliated Massachusetts General Hospital (MGH). Comparing blood samples from patients with gliomas with tumor biopsy tissues from the same patients, [...]

MASS General researchers show ddPCR brain tumor liquid biopsy assay has tenfold improvement in sensitivity over any prior assay2024-07-13T13:35:57+00:00
12 08, 2020

FDA approves first liquid biopsy next-generation sequencing companion diagnostic test

2020-08-12T13:40:43+00:00

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to [...]

FDA approves first liquid biopsy next-generation sequencing companion diagnostic test2020-08-12T13:40:43+00:00
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