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News & Events

30 08, 2022

First allogeneic cell therapy candidate engineered to target cd19 for b-cell malignancies receives IND clearance, will proceed to clinical trials

2024-07-10T19:49:27+00:00

Century Therapeutics, an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Company’s ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is [...]

First allogeneic cell therapy candidate engineered to target cd19 for b-cell malignancies receives IND clearance, will proceed to clinical trials2024-07-10T19:49:27+00:00
23 08, 2022

FDA approves the first gene therapy for people with beta-thalassemia who require regular red blood cell transfusions

2024-07-10T19:27:05+00:00

bluebird bio has announced the the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. “The FDA approval of ZYNTEGLO offers people with [...]

FDA approves the first gene therapy for people with beta-thalassemia who require regular red blood cell transfusions2024-07-10T19:27:05+00:00
9 08, 2022

How gene therapy can cure or treat diseases

2024-07-10T19:31:26+00:00

The genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick. Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. [...]

How gene therapy can cure or treat diseases2024-07-10T19:31:26+00:00
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
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