Therapeutic Class Archives - Page 14 of 53 - BioProcess InternationalBioProcess International

Hyasynth harnesses biopharma processes bringing yeast-made CBD to market

Using yeast fermentation in a similar way to insulin synthesis provides a cheaper, more sustainable way to make cannabinoids like CBD, says Hyasynth. Last month, Canadian firm Hyasynth received a $2.5 milllion milestone payment for its commercialization achievements in being first-to-market with cannabidiol (CBD) produced and extracted from a biomanufacturing setup. “It’s a typical yeast fermentation, so the equipment involved would be similar to the production of insulin,” Kevin Chen, CEO of Hyasynth told this publication. “We grow the yeast…

Bluebird: CMC and COVID delays push sickle cell gene therapy BLA back to 2022

by Dan Stanton

Bluebird bio has asked the US FDA to take a flexible and innovative approach to the CMC comparability data review for gene therapy candidate LentiGlobin. It had been estimated that bluebird bio was aiming to submit a Biologics License Application (BLA) for its gene therapy candidate LentiGlobin (autologous CD34+ cells encoding βA-T87Q-globin gene) in the second half of 2021. But following US Food and Drug Administration (FDA) concerns, guidance has been put back by a year, management said on a…

COVID highlighting advantage of in-house CAR-T manufacturing, says Celyad

by Dan Stanton

With COVID-19 disrupting the supply chain, the advantages of inhouse manufacturing capabilities have never been so clear says CAR-T developer Celyad Oncology. In 2012, Celyad Oncology – then known as Cardio3 BioSciences – received GMP certification for its a facility in Mont-Saint-Guibert, Belgium to support its allogeneic and autologous chimeric antigen receptor (CAR) T candidates. Eight years on and in the midst of a pandemic, the decision to invest in internal manufacturing capabilities has never seemed so astute, says Celyad’s…

Novartis continues Kymriah capacity expansion with Japanese CDMO

by Dan Stanton

Novartis has tripled production capacity for its commercial CAR-T therapy Kymriah over the past year and continues to ramp up through a deal with Japan’s Foundation for Biomedical Research and Innovation (FBRI). Kobe, Japan-based FBRI has received marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) to manufacture Kymriah (tisagenlecleucel) for Swiss pharma giant Novartis. The approval expands the manufacturing footprint of the chimeric antigen receptor (CAR) T-cell therapy, bringing Novartis its first Asian production facility. Furthermore, according…

Amyris and IDRI agree RNA vaccine platform deal

by Ben Hargreaves

The two partners will collaborate to develop an RNA vaccine against COVID-19, as well as vaccines for three additional indications. Amyris will license the Infectious Disease Research Institute (IDRI)’s novel ribonucleic acid (RNA) vaccine platform. Alongside the vaccine platform, Amyris will gain access to IDRI’s nanostructured lipid carrier (NLC) platform, which will be combined with its own semi-synthetic squalene technology to develop RNA vaccines against various infectious disease targets, potentially including influenza and certain cancer treatments. The first project will…

Bayer adds AAV-based gene therapy tech in $2bn AskBio buy

by Dan Stanton

The deal – which could be worth up to $4 billion – bolsters Bayer’s gene therapy ambitions through the addition of an AAV manufacturing platform, clinical-stage candidates, and a CDMO unit. German pharma giant Bayer is paying $2 billion up front with potential milestone payments up to another $2 billion for Research Triangle Park, North Carolina-based Asklepios BioPharmaceutical (AskBio). Founded in 2001 by Jude Samulski, the company’s present chief scientific officer, AskBio is developing gene therapies for neuromuscular diseases, central…

4D Pharma aims for NASDAQ as LBP space reaches maturity

by Dan Stanton

In a deal worth up to $37.6 million, live biotherapeutic (LBP) developer 4D Pharma has agreed to merge with Longevity Acquisition Corporation. The proposed merger will see the UK-based LBP developer receive $14.6 million from Longevity and could benefit from the proceeds of warrants to purchase Longevity shares worth up to $23 million. Longevity Acquisition Corporation is a NASDAQ-listed Special Purpose Acquisition Comp (SPAC) meaning once the merger is completed, the entity will be admitted to trading on NASDAQ under…

EMA committee nod for Orchard’s Libmeldy positive for AGC Biologics

by Gareth Macdonald

AGC Biologics looks set to start making Orchard Therapeutics’ Libmeldy after an EMA panel recommended the gene therapy be approved. The agency’s the Committee for Medicinal Products for Human Use (CHMP) recommended approval last week, explaining Libmeldy (cryopreserved autologous CD34+ cells encoding the arylsulfatase-A, or ARSA, gene) slows down progression of the lysosomal storage disease, metachromatic leukodystrophy (MLD). Orchard CEO Bobby Gaspar welcomed the recommendation. He said it “brings us closer to delivering a one-time, potentially transformative therapy for eligible…

With $30m in hand, Ori looks to advance closed cell therapy tech

by Dan Stanton

Ori Biotech will use $30 million from a Series A financing round to finalize and test its closed and automated cell and gene therapy technology. In January, Ori Biotech came out of stealth mode through a $9.4 million seed round, introducing the cell and gene therapy space to its technology platform, which aims to significantly reduce the cost of production of such therapies. Nine months on and the firm has raised a further $30 million in a Series A financing…

Tech used for new Ebola drug key to COVID-19 fight, Regeneron

by Gareth Macdonald

Regeneron says rapid response technologies pioneered to combat Ebola are helping accelerate efforts to create COVID-19 countermeasures. Last week Regeneron won US FDA approval for Inmazeb (atoltivimab, maftivimab and odesivimab-), its treatment for Zaire Ebola. The product is made from three monoclonal antibodies that target the Ebola glycoprotein, preventing the virus binding and infecting cells. Regeneron created Inmazeb using the same rapid response manufacturing platform it is currently using for RGEN-COV2, its COVID-19 treatment candidate. Shawn Lawrence, senior director, cell…