Search Results for: regenerative medicine

Optimizing the AAV Transfection Process in Suspension Cells

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Given the potentially curative nature of gene and gene-modified cell therapies and the successful launches of several such products over the past five years, markets and investments are growing significantly in the sector. In the United States alone, the US Food and Drug Administration has granted approval for several genetic therapies, including Strimvelis (autologous CD34+, developed by GlaxoSmithKline and later sold to Orchard Therapeutics) in 2016 Luxturna (voretigene neparvovec, Spark Therapeutics), Yescarta (axicabtagene ciloleucel, Kite Pharma/Gilead), and Kymriah (tisagenlecleucel, Novartis)…

October 29, 2021

Recombinant Proteins for Cell and Gene Therapy Research: A Conversation with Shenandoah Biotechnology

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Recombinant proteins such as growth factors and cytokines are essential for cell therapy, gene therapy and regenerative medicine research, development and manufacturing. These proteins are critical in the production of desired cell types and subsequent differentiation of cells, to deliver the desired effect. Founded 15 years ago, Shenandoah Biotechnology applies a proprietary method of folding and purifying recombinant proteins from both bacterial and mammalian systems to enable cost-effective, large-scale production of Cell Therapy Grade proteins to support these groundbreaking treatments.…

October 20, 2021

Iovance opens PA cell therapy plant; produces first batch of lifileucel

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The $85 million Iovance Cell Therapy Center (ICTC) has opened its doors at the Philadelphia Navy Yard with capacity to supply thousands of patients per year. Iovance celebrated the opening of its 136,000 square-foot commercial-scale production facility, commissioned in 2018 at a cost of around $85 million, this week. “Since Iovance was founded, we have been dedicated to advancing novel cell therapies for patients with solid tumor cancers,†Iovance CEO Frederick Vogt said. “A little over two years after breaking…

September 30, 2021

AGC Bio bolsters pDNA and mRNA capacity with German plant expansion

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CDMO AGC Bio will expand its Heidelberg, Germany facility to increase its manufacturing capacities for customer pDNA and mRNA projects. The expansion, of which financial details have not been disclosed, sees contract development manufacturing organization (CDMO) AGC Biologics boost its current production capacity for plasmid-DNA (pDNA) and messenger RNA (mRNA) by adding an additional manufacturing line. The Heidelberg expansion will also include additional warehouse capacity, a cleanroom for mRNA development and production, and a process development lab for microbial protein…

September 16, 2021

Flash drive: French CDMO to scale up viral vector production

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Flash Therapeutics has secured a three-year funding deal to help further develop its LentiFlash viral vector tech and to double its manufacturing capacity. The Toulouse, France-based contract development and manufacturing organization (CDMO) has developed its own lentiviral platform, LentiFlash, for use as a delivery vector in vaccinations, regenerative medicine, and gene-editing applications. “LentiFlash technology leads to a transient expression mediated by RNA delivery as lentiviral-based therapies leads to stable expression mediated by DNA delivery,†a spokesman from the firm told…

September 14, 2021

Sanofi bolsters stem cell biz with $1.9bn Kadmon buy

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Sanofi will grow its regenerative medicine  business through the acquisition of Kadmon, adding FDA-approved stem cell transplant Rezurock to its portfolio.   The deal sees French pharma giant Sanofi pay Kadmon Holdings $9.50 per share in cash, equalling a total equity value of approximately $1.9 billion. “The acquisition supports continued growth of our transplant business and adds a complementary offering that expands Sanofi’s portfolio and leverages the company’s expertise in stem cell transplant,†a spokesperson for Sanofi told BioProcess Insider.…

September 9, 2021

BioLife bolsters CGT portfolio through Sexton acquisition

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BioLife will boost its cell and gene therapy offerings by acquiring Cook Regentec spin out firm, Sexton Biotechnologies. BioLife Solutions has purchased the remaining shares of Sexton, a firm that provides manufacturing services for the cell and gene therapy industry, in a deal valued at $24 million. Sexton has two product lines; processing and handling solutions and cell performance supplements, which it uses to support cell and gene therapy production. Its portfolio includes human platelet lysate (HPL) media, a bio-defined…

September 7, 2021

Rentschler doubling commercial capacity through US expansion

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Driven by demand for an increasing complexity and diversity of modalities, CDMO Rentschler has broken ground on a second facility in Milford, Massachusetts. German contract development and manufacturing organization (CDMO) Rentschler laid down its US roots in 2019 when it bought a biomanufacturing facility from the now defunct Shire in January 2019 in Milford, Massachusetts – about 20 miles southwest of Boston. Now the firm has begun expanding its presence, breaking ground on facility adjacent to the ex-Shire plant set to…

August 13, 2021

Second Bluebird gene therapy approval a boon for Minaris

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CDMO Minaris says it will be the commercial manufacturer for Skysona (elivaldogene autotemcel, Lenti-D), a second Bluebird Bio gene therapy approved by the European Commission. The European Commission (EC) granted marketing authorization of Skysona for the treatment of early cerebral adrenoleukodystrophy (CALD) yesterday. The one-time gene therapy uses a patient’s own hematopoietic stem cells (HSC) to treat the underlying cause of the neurologic condition CALD. SKYSONA uses ex vivo transduction with the Lenti-D lentiviral vector (LVV) to add functional copies…

July 22, 2021

Mesenchymal Stromal Stem Cells: Next Steps and Considerations for CGMP Manufacturing

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Massimo Dominici is scientific founder of Rigenerand srl, a joint venture between RanD (a biomedical company producing bioreactors for liver support and chemohyperthermic technology for cancer) and experts in cell and gene therapy at the University of Modena and Emilia Region in Italy. Rigenerand develops and manufactures medicinal products for cell-therapy applications (primarily for regenerative medicine and oncology) and three-dimensional (3D) bioreactors as an alternative to animal testing for preclinical investigations. The company also produces its own pipeline of cell…

June 18, 2021