Search Results for: regenerative medicine

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

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Marketing unapproved stem cell therapies and cGMP deviations have landed California’s StemGenex Biologic Laboratories with a US Food and Drug Administration (FDA) warning letter. The letter cites issues in good manufacturing practice (GMP) and the unlawful marketing of an unapproved stromal vascular fraction (SVF) stem cell therapy, processed from autologous adipose tissue. It was sent on October 31, following an FDA inspection at StemGenex Biologic Laboratories’ (SGBL) facility in San Diego, California in January this year. According to the Agency,…

November 16, 2018

Astellas invests $256m in Japanese and US antibody and cell therapy sites

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Astellas says it is responding to the supply needs of future pipeline by constructing two multi-modality Japanese sites and relocating a regenerative medicine plant in Massachusetts. Both R&D and manufacturing are being looked at through the expansion of sites in Toyama and Tsukuba, Japan, and Massachusetts, US to progress the development and commercialization of Astellas’ portfolio. “Astellas is responding to the progress being made in the development and launch of new drugs from its existing portfolio and pipeline,†a spokesperson…

November 5, 2018

GSK selects Hitachi to make T-cell therapy

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Hitachi Chemical Advanced Therapeutics Solutions (HCATS) will make clinical batches of GlaxoSmithKline’s T-cell receptor therapy targeting NY-ESO-1 from its New Jersey site. The three-year agreement will see HCATS manufacture clinical batches of GSK’s T-cell receptor therapy targeting New York esophageal squamous cell carcinoma 1 (NY-ESO-1). The SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell therapy is one of a number of cancer immunotherapies being codeveloped between GSK and Oxford, UK-based Adaptimmune, in a collaboration inked in 2014. The clinical production of…

November 5, 2018

MaSTherCell wins Iovance deal as commercial cell therapy demand increases

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Cell therapy CDMO MaSTherCell will produce late-stage clinical supply of an adoptive cell therapy for Iovance Biotherapeutics from its facility in Belgium. Iovance has selected MaSTherCell S.A., a cellular therapy-focused contract development and manufacturing organization (CDMO) and subsidiary of Orgenesis, to manufacture an adoptive cell therapy using its tumor infiltrating lymphocyte (TIL) product as it goes into late-stage trials in Europe. The manufacturing will take place from MaSTherCell’s plant based in Belgium, which according to a spokesperson from the CDMO…

October 19, 2018

BioProcess Insider for October

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Launched in June 2018, the BioProcess Insider digital information portal delivers the latest financial and business news and expert insider views influencing the commercialization of biopharmaceuticals. Here are just a few recent stories edited for our space limitations in print. For more discussion and in-depth analysis, check out the website at www.bioprocessinsider.com. Every edition provides expert and insider perspectives on current financial movements and deal-making; the newest technology purchases and capacity investments; regulations affecting the bioprocessing sector; global market actions…

October 15, 2018

Bridging Polymer Science to Biotechnology Applications: A Single-Use Technology Conference Report

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Single-use (SU) technology is used more every year throughout the biotechnology industry. As applications now span from cell banking to drug product, that in turn is raising interest in the interaction of extractables with proteins and cells. The second “Single-Use Technologies†conference organized through Engineering Conference International (ECI) was subtitled “Bridging Polymer Science to Biotechnology Applications†and delved into the science of plastics in bioprocessing applications. On 7–10 May 2017 at the Hotel dos Templários in Tomar, Portugal, people from…

October 15, 2018

Exclusive: Samsung BioLogics poised to enter cell therapy space

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After building three large-scale biomanufacturing plants, CDMO Samsung BioLogics has told BioProcess Insider it is adding single-use capacity and is considering expanding into stem cell therapy services. It has been nine years since Samsung BioLogics entered the third-party biologics space, in which time it has brought two commercial biomanufacturing facilities online with a third expected to be fully validated by the end of this year. When operational, the firm’s site in Incheon, South Korea will boast a total of 362,000…

September 12, 2018

Using New Technologies to Compress Timelines, Increase Capacity, and Reduce Costs: Speed — Why, When, and How

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Moderator Tom Ransohoff, with Jorg Thommes, Chris Love, Rajesh Beri, and Geoffrey Hodge For biopharmaceuticals to mature as a process industry, companies need to embrace the ability to adopt new technologies and bring new operational approaches to their biomanufacturing facilities. In this roundtable about adopting and implementing new technologies in the biologics industry, moderator Tom Ransohoff stressed the importance of understanding drivers for adopting new technologies and of developing enabling processes that factor in associated risks and challenges. He offered…

August 23, 2018

Pluristem and Thermo Fisher Look to Plug Gaps in Cell Therapy Manufacture

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Pluristem and Thermo Fisher will work to address the lack of technologies available to cell therapy manufacturers for the cultivation and processing of allogeneic products. “There is a lack of technologies for the cultivation and processing of allogeneic products whose potential is high scale production,†Yaky Yanay, president and co-CEO of Pluristem Therapeutics told BioProcess Insider. “Some of the gaps are in the technology itself, some are in the quality or the availability of raw materials.†To minimize some of…

July 20, 2018

FDA Guidelines Show ‘Growing Maturity’ of Gene Therapy Space, Says Industry

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The US FDA has published six draft guidance documents related to gene therapies. The inclusion of manufacturing guidelines will help modernize the commercialization process to keep pace with the growth technology, say industry groups. Over the past 12 months, the US food and Drug Administration (FDA) has approved three separate gene therapy products: Novartis’ Kymriah (tisagenlecleucel), Gilead/Kite’s Yescarta (axicabtagene ciloleucel), and Spark Therapeutics’ Luxturna (voretigene neparvovec). And with a growing number of gene therapies moving through the clinic – there…

July 19, 2018