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News & Events

16 02, 2021

Avance Biosciences Expanding Houston Campus in Support of Cell and Gene Therapy Drug Development

2021-02-16T15:23:52+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 Campus in Support of Cell and Gene Therapy Drug Development2021-02-16T15:23:52+00:00
5 02, 2021

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

2021-02-05T16:31:04+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 pandemic2021-02-05T16:31:04+00:00
7 12, 2020

Avance Biosciences Recognized as Top 10 Genomics Solutions Company

2020-12-07T15:48:27+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 Company2020-12-07T15:48:27+00:00
16 10, 2020

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

2020-10-16T15:29:16+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 assay2020-10-16T15:29:16+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
2 07, 2020

Join Us At Onco Cell Therapy Summit – July 7-8 – Online

2020-07-02T17:53:14+00:00

Avance Biosciences specializes in assay development, validation, and sample testing services supporting our clients for their drug development initiatives and GMP manufacturing activities.  We are a leader in applying state-of-art technologies, such as next generation sequencing (NGS) and digital droplet PCR (ddPCR), to improve the effectiveness and efficiency of biologic tests. [...]

Join Us At Onco Cell Therapy Summit – July 7-8 – Online2020-07-02T17:53:14+00:00
29 01, 2020

Join Us At BioProcess International US West – March 9-12 – Santa Clara, CA

2020-01-30T14:09:21+00:00

Avance Biosciences specializes in assay development, validation, and sample testing services supporting our clients for their drug development initiatives and GMP manufacturing activities.  We are a leader in applying state-of-art technologies, such as next generation sequencing (NGS) and digital droplet PCR (ddPCR), to improve the effectiveness and efficiency of biologic tests. [...]

Join Us At BioProcess International US West – March 9-12 – Santa Clara, CA2020-01-30T14:09:21+00:00
17 12, 2019

NIH launches first U.S. clinical trial of patient-derived stem cell therapy to replace dying cells in retina

2019-12-18T12:38:05+00:00

NEI-led study to test safety of treatment for a form of age-related macular degeneration that currently lacks treatment. Researchers at the National Eye Institute (NEI) are launching a clinical trial to test the safety of a novel patient-specific stem cell-based therapy to treat geographic atrophy, the advanced “dry” form of age-related macular degeneration (AMD), [...]

NIH launches first U.S. clinical trial of patient-derived stem cell therapy to replace dying cells in retina2019-12-18T12:38:05+00:00
29 10, 2019

FDA grants CAR T-cell therapy RMAT designation for multiple myeloma

2019-10-29T15:36:52+00:00

The United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to the investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM)...

FDA grants CAR T-cell therapy RMAT designation for multiple myeloma2019-10-29T15:36:52+00:00
22 10, 2019

New gene therapy drug brings in $160 million, beating expectations

2019-10-22T13:29:42+00:00

ZURICH (Reuters) - Swiss drugmaker Novartis (NOVN.S) boosted its 2019 forecasts on Tuesday after beating third-quarter expectations, a feat helped by the sales debut of gene therapy Zolgensma, the world’s most expensive one-time treatment. CEO Vas Narasimhan’s bet on the potential cure for spinal muscular atrophy (SMA) has drawn scrutiny, initially due to its [...]

New gene therapy drug brings in $160 million, beating expectations2019-10-22T13:29:42+00:00