Search Results for: regenerative medicine

FDA Seeks Injunctions in Fight Against $2.4bn Unapproved Stem Cell Market

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Industry group International Society Cell and Gene Therapy (ISCT) has supported regulatory actions aimed at permanently closing two unapproved US stem cell clinics. The US Food and Drug Administration (FDA) is seeking a permanent injunction against Sunrise, Florida-based US Stem Cell Clinic LLC and Californian firm California Stem Cell Treatment Center Inc for marketing stem cell products without approval. The actions are the latest in a crackdown by the regulator on unproven cellular therapies (UCT) and complement a suite of…

July 3, 2018

Industry Looks to ‘Lucrative’ Opportunities for Off-the-Shelf Cell Therapies

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Allogeneic cell therapies have greater commercial potential than autologous products, an industry survey finds. Respondents also believe there are a lack of third-party capabilities to make these new therapies. When Novartis’s Kymriah (tisagenlecleucel) received the regulatory thumbs up in August 2017, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb described regenerative medicines as being “no longer the stuff of science fiction.†The approval of Gilead/Kite’s Yescarta (axicabtagene ciloleucel) weeks later helped cement the safety and commercial potential of CAR-T…

June 29, 2018

Demonstrating Scalable T-Cell Expansion in Stirred-Tank Bioreactors

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Emerging cell therapies have excited the pharmaceutical industry because they indicate potential new pathways to treat some of the most life-threatening diseases. T-cell therapies currently are the flagship technology in cell therapy with recent US FDA approvals of Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) treatments. Those therapies and others still in development use peripheral blood isolated lymphocytes (PBLs) modified with chimeric antigen receptors (CARs) or modified T-cell receptors (TCRs) to trigger the innate cytotoxic response of these immune…

June 23, 2018

June Spotlight

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Holding True to the Price-Cap Pledge As in previous years, 2018 started with more than 30 drugs increasing in price on the US market. However, data and analysis firm GlobalData observes that criticism from politicians and the public seems to be keeping the industry to a 10% self-imposed price-hike limit. It began with Allergan CEO Brent Saunders pledging to police pricing in 2016, when he stated that his company would limit itself to one price increase per year and only…

June 20, 2018

Automated Tech Ups Hitachi’s Cell Therapy Interest

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Recent entrant to the regenerative medicine space Hitachi Chemical has partnered with Invetech to commercialize the Counter-Flow Centrifugation system – an automated platform for cell therapy manufacturing. The partnership will allow customers of Hitachi Chemical Advanced Therapeutics Solutions (HCATS) to access Invetech’s Counter-Flow Centrifugation (CFC) system in the clinical and commercial manufacturing of cell-based therapies using closed single-use disposables. Hitachi entered the regenerative medicine space in 2017 through the $US75 million (€64 million) acquisition of cell therapy contract development and…

June 11, 2018

Media Control: Fujifilm Buys Irvine Scientific for $800m

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The acquisition of cell culture media firm Irvine Scientific complements Fujifilm’s bioprocessing business and helps ensure supply chain control, the company told us at BIO. Fujifilm Corporation has completed the acquisition of Irvine Scientific (ISUS) and IS Japan (ISJ) for US$800 million (€680 million) from fellow Japanese-headquartered firm JXTG Nippon Oil & Energy Corporation. The deal, first announced in March, brings Fujifilm an increased presence in the life sciences service industry, adding a range of media for industrial cell culture,…

June 8, 2018

May Spotlight

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Welcome New BPI Colleague In April, BioProcess International waved a reluctant goodbye to European strategic marketing consultant Joanna Hendrikx. Pregnant with her second child, she is looking forward to devoting herself exclusively to motherhood. We will miss her energy, finesse, and sense of humor even as we welcome our new colleague taking over her role here. Victoria Biscoe has a long history with Informa, our parent company, having joined in 2010 as a key account manager for the Informa Life…

June 1, 2018

Sumitomo Dainippon Pharma Co., Ltd. Chooses Cytonome’s GigaSort® Cell Sorting Technology for Cell Bioprocessing

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Sumitomo Dainippon Pharma Co., Ltd. has installed the GigaSort® Platform in their newly opened Manufacturing Plant for Regenerative Medicine & Cell Therapy in Osaka, Japan. The center is the world’s first commercial iPSC plant. The GigaSort platform is a microfluidic based cell sorting technology that allows the selection of highly specific and pure cell populations in a manufacturing environment. “We are thrilled to be providing the GigaSort technology to Sumitomo Dainippon Pharma Co., Ltd. to enable exciting advances in regenerative…

March 29, 2018

Driving Cell Therapy Innovation: Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies

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After many trials and errors — and milestones — regenerative medicine has become a mainstream part of the biopharmaceutical industry, supported by at least 670 companies and clinics of all sizes. But many experiences in the protein-based industry segment can be leveraged to further improve successful commercialization of advanced therapies. At the 2017 Biotech Week Boston conference, BioProcess International editor in chief Anne Montgomery hosted a panel of industry cell therapy experts to discuss key lessons that can be gleaned…

March 27, 2018

Cell Expansion with Dissolvable Microcarriers

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In recent years we have seen an exponential increase in the number of companies testing and validating new regenerative medicine products. Many of these products are reaching late-phase trials with the potential to receive final approval and marketing authorization from regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the past several years, we have seen successful launches of regenerative medicine products, including Holoclar (Holostem Advanced Therapies), Kymriah (tisagenlecleucel, Novartis), Yescarta…

March 27, 2018