Therapeutic Class Archives - Page 48 of 53 - BioProcess InternationalBioProcess International

Anti-antibody anybody? Bio-Rad range to target Lucentis biosimilar developers

Bio-Rad has launched a range of anti-ranibizumab antibodies for PK and immunogenicity assays on the back of increased Lucentis biosimilar development. Bio-Rad Laboratories will offer customers a range of recombinant monoclonal anti-ranibizumab antibodies that are highly specific for Lucentis (ranibizumab), or the complex of ranibizumab with its target, vascular endothelial growth factor A (VEGF-A). The anti-antibodies are to be used in pharmacokinetic (PK) and immunogenicity assays, and the product launch is due to the increased interest in Lucentis biosimilar development,…

Regeneron teams up and takes $100m stake in bluebird bio

by Dan Stanton

Regeneron has increased its interest in cellular therapies through a T cell co-development partnership with bluebird bio. The deal sees Regeneron Pharmaceuticals and bluebird bio combine their respective tech platforms to discover, develop and commercialize an initial six candidates against tumor-specific proteins and peptides, including chimeric antigen receptor (CAR) T and other T cell receptors (TCRs). As part of the collaboration, Regeneron has invested $100 million (€87 million) in its new partner bluebird, buying 420,000 shares at a price of…

Esco Aster to transfer CAR-T tech to Chinese biomanufacturing plant

by Dan Stanton

The Singapore-based CDMO will fit out Wuhan Bio-Raid Biotechnology’s facility in China with its lentiviral vector platform and bioproduction technologies. Esco Aster has signed a memorandum of understanding (MoU) to use its lentiviral vector platform and bioproduction technologies to support Wuhan Bio-Raid’s chimeric antigen receptor (CAR) T-cell therapy pipeline in China. “Under the MoU, both parties have achieved a broad understanding to increase the speed of CAR-T development in China,” Esco Aster spokesperson Ai San Yip told BioProcess Insider. This…

BioTime spinning out regenerative med firm AgeX

by Dan Stanton

BioTime has received US$43 million (€37 million) from Juvenescence for a stake in AgeX and plans to spin the cell therapy subsidiary out in September. In April 2017, Californian late-stage biotech BioTime formed the subsidiary AgeX therapeutics to focus on its human aging candidates derived from regenerative stem cells. Earlier this year, fellow aging-focused firm Juvenescence made a $5 million investment in the subsidiary, and this week has upped its stake by 14.4 million shares paying BioTime $21.6 million in…

Lonza: CAR-T Manufacturing Glitch an Industry Problem, not Just Novartis’s

by Dan Stanton

Novartis has reported issues around the manufacture of Kymriah (tisagenlecleucel). With CAR-T being a new field, teething problems are normal, says CDMO Lonza. In August 2017, Novartis became the first company to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy. But during its Q2 results, the Swiss Biopharma admitted some issues in the manufacturing of the therapy for its diffuse large B-cell lymphoma (DLBCL) indication. “We have seen some variability in our…

Sangamo Bets on CAR-Treg Through $84m TxCell Acquisition

by Dan Stanton

CAR-Treg is the next biology of interest for gene-modified cellular therapies says TxCell, which is set to be acquired by Sangamo Therapeutics. Sangamo Therapeutics has agreed to buy French biotech TxCell for approximately €72 million (US$84 million), bolstering its pipeline with cellular immunotherapies based on regulatory T lymphocytes, or Tregs. The acquisition will help bring candidates, including TX200 for transplant rejection, through the clinic and towards commercialization, TxCell’s CEO Stephane Boissel told Bioprocess Insider. “We did not want to start…

FDA Greasing the Wheel for Biosimilar Adoption Through Action Plan

by Dan Stanton

The US FDA has published an action plan to promote and expedite biosimilar competition. Healthcare consultant Steven Lucio tells us “we are at a critical point in time in the biosimilar development landscape.” Last week, the US Food and Drug Administration (FDA) published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire for new biologics innovation. “By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest…

Neupogen Biosimilar Success: Pfizer Banks on Discounts and Patient Confidence

by Dan Stanton

The US Food and Drug Administration (FDA) has approved Pfizer’s Nivestym; a second biosimilar of Amgen’s Neupogen (filgrastim). In March 2015, the FDA approved its first biosimilar: a version of Neupogen called Zarxio, marketed by Novartis subsidiary Sandoz. Three years later and a second filgrastim biosimilar is close to being available after the FDA approved Pfizer’s product NIvestym. A spokesperson from the Biopharma firm told BioProcess Insider Pfizer will be able to compete against both Amgen’s reference biologic and Sandoz’s…

Univercells $19m Booster Shot to Help Disrupt Vaccine Industry

by Dan Stanton

Traditional vaccine makers have limited incentive to invest in new technologies and processes says Univercells, which hopes to advance its own viral vaccines produced in micro-facilities. Univercells has raised €16 million (US$18.7 million) of funding in a Series B financing round led by Global Health Investment Fund. Some of the capital will be used to increase the impact of its proprietary viral platform through the expansion of its portfolio. “Following the platform proof of concept, with its sIPV development program…

‘Dramatic’ Gene Therapy Demand Drives Viral Vector Delays

by Dan Stanton

Some gene therapy developers are waiting more than a year for viral vectors due to the shortage in third-party services, says European CDMO Yposkesi. French contract development and manufacturing organization (CDMO) Yposkesi claims to have the largest industrial platform for the GMP manufacture of viral vectors for gene therapies in Europe. The firm has four independent production suites and two fill & finish suites, with current capacity of 35 batches per year. And now the manufacturer is set to grow…