cell therapy system News
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BioCardia Establishes New Manufacturing Facility to Enable Its Cell Therapy Product Candidates
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that it has entered into a long-term lease for a new facility in Sunnyvale, California. This facility is being built out to support the manufacturing of BioCardia’s cell and device products and product candidates across the ...
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BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure
BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed to be the first cardiac cell therapy to ...
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SQZ Biotechnologies Announces Integrated Point-ofCare Cell Therapy Manufacturing System Demonstrated Comparable or Better Performance Than a More Conventional Clean Room-Based Process
WATERTOWN, Mass.--(BUSINESS WIRE)-- SQZ Biotechnologies (NYSE: SQZ) announced today that the company’s rst generation, integrated point-of-care (POC) cell therapy manufacturing system demonstrated superior process performance and comparable or improved product specications relative to current clean room-based processes used in clinical development. The non-clinical studies showed that the ...
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BioCardia Announces First Patient Treated in CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia
BioCardia, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first patient in its Phase III pivotal CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial for patients with no option chronic myocardial ischemia with refractory angina. These patients experience ...
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BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada
BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has received a No Objection Letter from Health Canada, the country’s health services agency, allowing the CardiAMP® Heart Failure Trial to expand into Canada. The Phase III pivotal trial is currently enrolling ...
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New Culture Medium Supports Expansion of Natural Killer Cells for Cell and Gene Therapies
Thermo Fisher Scientific today announced the launch of Gibco Cell Therapy Systems (CTS) NK-Xpander Medium, a GMP-manufactured cell culture medium that supports large-scale growth and culture of functional natural killer (NK) cells with or without the use of feeder cells. This is the first medium from Thermo Fisher specifically designed to support expansion of NK cells for cell therapy ...
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Thermo Fisher Scientific and JW Therapeutics Announce CAR-T Partnership in China
Thermo Fisher Scientific, the world leader in serving science, has signed an agreement with JW Therapeutics, a leading cell therapy company, to ensure non-exclusive commercial access to Thermo Fisher's Gibco CTS Dynabeads CD3/CD28. The agreement will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW ...
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Thermo Fisher Scientific Launches Modular Closed Cell Processing System for Cell Therapy Manufacturing
Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development ...
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GPB Scientific Accelerates Cell Therapy Manufacturing with Key Hires
GPB Scientific, Inc., a key enabling technology company for cell therapy manufacturing, announced the hiring of Gaurav Vij and Joan Haab, PhD, as it prepares to make cell therapy available to the largest number of patients. Mr. Vij will serve as the company's first Chief Business Officer, and Dr. Haab as its first Senior Vice President, Manufacturing and Supply Chain Operations, key positions for ...
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Tissue Genesis` Icellator X Delivers Results in First Clinical Application
Tissue Genesis, a leading developer of cell therapy processing systems, announced today that an initial group of patients was successfully treated in the first clinical application of its Icellator® X technology at the Okyanos Center for Regenerative Medicine in Freeport, Bahamas. The new fully enclosed and automated system generated a higher yield of stem cells from adipose (fat) tissue than ...
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Thermo Fisher Scientific and University of California, San Francisco to Open Cell Therapy cGMP Manufacturing and Collaboration Center
Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, and the University of California, San Francisco (UCSF) today announced they have formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies. Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot, state-of-the-art cell therapy development, manufacturing ...
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GPB Scientific Announces Initial Availability of Advanced Cell Separation Platform; Name Change to Curate Biosciences
GPB Scientific, Inc. has launched its go-to-market activities for the transformational Curate® Cell Processing System to streamline the manufacture of cell therapies, making them economically and reliably available to the largest number of patients. The company's advanced cell separation platform is in evaluations at select biopharmas, contract manufacturers, and academic centers ahead of the ...
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Curate Biosciences and City of Hope Evaluate Innovative Cell Separation for HIV CAR-T Cell Therapy Production
Curate Biosciences, a key enabling technology company for cell therapy manufacturing, announced the first outcome of its Technology Access Program, which is dedicated to converting research into real-world treatments and cures as rapidly as possible. City of Hope, one of the largest cancer research and treatment organizations in the United States, has evaluated the Curate® Cell Processing ...
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Caribou Biosciences Presents Positive Preclinical Data for Allogeneic Anti-BCMA CAR-T Cell Therapy Candidate CB-011 at the American Association for Cancer Research (AACR) Annual Meeting
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy immune cloaked to blunt both T- and NK-mediated immune cell rejection, enabling more durable antitumor activity -- Data support an expected Investigational New Drug (IND) application submission in 2022 for CB-011, Caribou’s second allogeneic cell therapy product candidate -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading ...
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