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News & Events

2 08, 2022

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing

2024-07-10T19:49:08+00:00

Effort to address challenges to the manufacturing scale-up of cell-based therapies follows release of Project A-Gene for gene therapy in 2021 The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL) today released Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case [...]

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing2024-07-10T19:49:08+00:00
20 07, 2022

New next-gen sequencing technique could accelerate and improve mRNA therapies by quantifying how LNPs deliver mRNA into cells

2024-07-10T18:07:12+00:00

Therapeutics based on messenger RNA, or mRNA, can potentially treat a wide range of maladies, including cancer, genetic diseases, and as the world has learned in recent years, deadly viruses. To work, these drugs must be delivered directly to target cells in nanoscale bubbles of fat called lipid nanoparticles, or LNPs — mRNA isn’t [...]

New next-gen sequencing technique could accelerate and improve mRNA therapies by quantifying how LNPs deliver mRNA into cells2024-07-10T18:07:12+00:00
12 07, 2022

New method combines a T-cell “barcode” with single-cell RNA sequencing to enhance CAR T–cell therapy

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

Scientists at St. Jude Children’s Research Hospital have developed a method that may be able to improve CAR T-cell therapies by identifying the early cells that become effective at killing cancer. St. Jude Children’s Research Hospital scientists have demonstrated that the long-term performance of cancer-killing chimeric antigen receptor (CAR) T cells can, in some cases, be predicted [...]

New method combines a T-cell “barcode” with single-cell RNA sequencing to enhance CAR T–cell therapy2024-07-13T13:33:33+00:00
28 06, 2022

Sana Biotechnology to expand its manufacturing, advance cell-based therapies in neurological disorders

2024-07-10T19:30:27+00:00

The University of Rochester Medical Center (URMC) and Sana Biotechnology have entered into an agreement which will allow Sana to expand its manufacturing footprint and create new job opportunities in Rochester. Sana, a company focused on creating and delivering engineered cells as medicines, also operates in Seattle, Cambridge, and South San Francisco. The company has programs [...]

Sana Biotechnology to expand its manufacturing, advance cell-based therapies in neurological disorders2024-07-10T19:30:27+00:00
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
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