Search Results for: regenerative medicine

Process Development of a Closed CAR-T Manufacturing Process

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Representing GE Healthcare, Rohin Iyer joined BPI Theater at BIO on Tuesday, 4 June 2019, to explore how academic and clinical drug sponsors could partner with service providers to develop bioprocesses more akin to those in the industry at large. Iyer chronicled GE’s collaboration with the non-profit Center for Commercialization of Regenerative Medicine (CCRM), a public–private partnership in which a team of 105 people (both GE Healthcare and CCRM employees) work together at one location. Elaborating this example, Iyer pointed…

July 18, 2019

M&A hungry BioLife to buy cold-chain services firm SAVSU

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Having gradually increased its stake in the cloud-based cold-chain management firm, BioLife Solutions will buy the remaining 56% of shares to bolster its cell and gene therapy offering. Supplier of cell and gene therapy tools BioLife has been experiencing huge growth over the past few quarters (51% increase year-on-year for its Q1 2019, for example) due to the high demand for bio-preservation media and automated thawing products. The firm has been looking to take advantage of the continued demand from…

July 9, 2019

Stem cell clinic compliance slower than expected, says FDA

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The US FDA continues its clampdown on unapproved stem cell therapies but says the pace of progress in making clinics comply is slower than expected. In November 2017, the US Food and Drug Administration (FDA) laid down a comprehensive regenerative medicine framework aimed at spurring innovation and access to potentially transformative products, while ensuring safety and efficacy for such products. This included warnings against providers of unapproved and unproven stem cell therapies, and a period of a risk-based approach to…

June 28, 2019

Hitachi supplying gene therapy Zynteglo for bluebird in EU

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bluebird bio will use Hitachi Chemical subsidiary apceth Biopharma to commercially manufacture its recently EU approved gene therapy Zynteglo. Earlier this month, the European Medicines Agency (EMA) approved orphan drug Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – previously known as LentiGlobin – as a one-off treatment for beta-thalassaemia. Zynteglo uses a lentiviral viral vector to add functional copies of a modified β-globin gene into a patient’s own stem cells, addressing the underlying genetic cause of patients for whom a…

June 13, 2019

Rexgenero adds CMO to speed up cell therapy trials

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Regenerative medicine firm has contracted the German Red Cross Blood Donor Service to expand production of its autologous bone marrow-based cell therapy REX-001. London, UK-headquartered firm Rexgenero’s lead product is REX-001 is in two Phase III trials both of which are in diabetes patients. The firm manufactures the autologous cell therapy from its production site in Seville, Spain, added through its incorporation of Spanish subsidiary Rexgenero Biosciences S.L in 2015. But to increase production and expedite clinical trials, the firm has…

June 4, 2019

Cryoport acquires Cryogene for $20.5m, adds Texas biostorage site

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The combination of cold-chain logistics and biostorage places Cryoport in good stead for the arrival of allogeneic cell therapies, an analyst says. Cryogene’s proximity to Lonza’s Houston site is also a boon. Cryoport, a provider of temperature-controlled logistics solutions specifically in the cell and gene therapy space, paid $20.5 million (€18.3 million) in cash for Houston, Texas-based biostorage and biobanking firm Cryogene. Cryogene brings a 21,000 square-foot biostorage facility – which specializes storing biological specimens, materials and samples – to…

May 17, 2019

April From the Editor

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Our focus on regenerative medicine this month, with its inherent personalized approach, brings to my mind aspects of “the patient experience.†Last week at BPI West in Santa Clara, CA, I was intensely moved by the performance of lymphoma survivor Toby Peach (www.tobypeach.co.uk). Our KNect365 colleagues will be asking him back this fall for the BPI Conference in Boston, and I encourage you not to miss him if you’re there. Many of us will be touched by some form of…

April 18, 2019

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production: Part 1: Introduction and Manufacturing Process

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by Bio-Process Systems Alliance Cell and Gene Therapy Committee The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Corporate members include plastic-equipment suppliers, service providers, and users in the biopharmaceutical industry who share this mission. A key focus of BPSA’s core activities is to educate its members and others through sharing of information and development…

April 18, 2019

Innovation Leadership in Drug Development

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A “sea change†in the biotechnology and pharmaceutical industries is leading established players to recruit a new type of drug-development leader. Disruptive innovators such as LG Chem Life Sciences, Google, and Nestlé are challenging established life-science companies to be nimbler, more creative, and more adept at applying new and emerging technologies. To spur creativity and entrepreneurship in research and development, smaller companies and Big Pharma corporations alike are recruiting leaders from different fields both inside and outside the life sciences.…

April 18, 2019

Allele SCM partnership looks to stem cells to treat diabetes

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Allele Biotechnology has teamed with SCM Lifescience to develop diabetes therapies using pancreatic beta cells derived from induced pluripotent stem cells (iPSCs). “By nature, pluripotent stem cells like iPSCs can be expanded indefinitely and differentiated into all human tissue types, including pancreatic cells,†a spokesperson from the San Diego-based biotech Allele, told Bioprocess Insider. Therefore, they can be a viable option for diabetes treatment. “iPSC-derived cells are already known to have biological functions, such as blood sugar sensing and insulin…

April 18, 2019