BioInformant

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AABB Releases New Publication: Getting Started in Processing for Biotherapies

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September 10, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce the publication of a new book, Getting Started in Processing for Biotherapies, in print and digital formats.

Getting Started in Processing for Biotherapies outlines the major processes to consider in planning for a new or expanded biotherapies processing laboratory and shares how to bring plans from conception to reality. This new essential resource is intended to assist facilities and professionals at the beginning of a journey, covering foundational concepts and requirements and offering options to consider before acting. [Read more…]

Ncardia Launches Panel of Ready-to-Use Assays to Streamline Screening and Selection of New Therapeutic Candidates

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New assays based on iPSC help accelerate drug discovery by giving drug innovators in neurodegenerative diseases high quality data on a broad range of disease-relevant read-outs.

September 10, 2024, LEIDEN, Netherlands — Ncardia, a leading human iPSC company, announced today the launch of a new panel of ready-to-use assays designed to streamline the screening and selection of new therapeutic candidates, with a specific focus on neurodegenerative diseases. [Read more…]

BlueRock Receive FDA clearance of IND for Investigational iPSC-derived Cell Therapy OpCT-001

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BlueRock Therapeutics announces FDA clearance of IND application for investigational iPSC-derived cell therapy OpCT-001 for the treatment of primary photoreceptor diseases

Cambridge, MA USA, Sept. 03, 2024 — BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. [Read more…]

SCG Cell Therapy And A*Star Launch Joint Labs With S$30M To Advance iPSC Technology for Scalable GMP Manufacturing Of Cellular Immunotherapies

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  • Collaboration aims to develop scalable GMP-grade iPSC manufacturing processes and therapeutic candidates to facilitate research leading to translation of novel cellular immunotherapies.
  • Launch of the joint labs builds on existing license, research collaboration and Memorandum of Understanding between SCG Cell Therapy and A*STAR.

August 16, 2024, Singapore – SCG Cell Therapy (SCG) and the Agency for Science, Technology and Research (A*STAR) announced the launch joint laboratories for cellular immunotherapies. This collaboration, at a combined funding of close to S$30 million supported under Singapore’s Research, Innovation and Enterprise 2025 Plan (RIE2025), aims to advance the development of induced pluripotent stem cell (iPSC) technology to produce novel cell therapies that meet Good Manufacturing Practice (GMP) standards. The collaboration will also establish a talent development programme to train the next generation of experts in this field, in accordance with current GMP and regulatory requirements. [Read more…]

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