Therapeutic Class

Seqirus looks to next-gen mRNA for seasonal flu vaccine

Seqirus says it will look to build large-scale manufacturing capacity to support its self-amplifying messenger RNA (sa-mRNA) ambitions in the seasonal influenza space. Seqirus has long had a leading role in the seasonal influenza space through its portfolio of products, including both egg-based and cell-based vaccine. But now the firm is stepping up its efforts to develop a flu vaccine based on mRNA, launching a dedicated program to support development of its next-generation sa-mRNA platform with plans to set up…

eBook: Cell and Gene Therapies —
A 2021 Industry Update

The US Food and Drug Administration (FDA) reports that as of June 2021, 22 advanced therapy products have received regulatory approval in the United States. The first such product gained regulatory approval in 2010. Since then, hundreds of cell and gene therapies have advanced to clinical evaluation, but few products have reached commercial stages — and those that have done so have been hindered by manufacturing problems. In this eBook, writers from the BioProcess Insider and Project Farma analyze trends…

Polyplus reagent aims to ease CGT manufacturing issues

Polyplus has added a reagent to its existing product line developed specifically to enable large-scale viral vector manufacturing. The French-biotech said the reagent has been developed to complement its existing FectoVir-AAV reagent line. “FectoVIR-AAV is a transfection reagent, hence a key component of upstream manufacturing of viral vectors used for gene therapy,” a spokesperson for Polyplus told BioProcess Insider. “FectoVIR-AAV transports plasmid DNA across the cell membrane. In gene therapy viral vector manufacturing, three plasmids are transfected at the same time…

Podcast: GSK’s digital twin approach to vaccine development

GSK relates its experience of adopting a digital twin technology initiative for its vaccine business on the latest episode of the BioProcess Insider Expression Platform podcast. A digital twin is a virtual representation that serves as the real-time digital counterpart of a physical object or process. Biopharma giant GlaxoSmithKline (GSK) has adopted this technology to advance its vaccine development and manufacturing division. A year after partnering with Siemens and Atos to pilot a digital twin in order to create a…

Second Bluebird gene therapy approval a boon for Minaris

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…

Sanofi doubles down on mRNA vaccines with $475m annual booster shot

‘The mRNA story is just beginning’ says Sanofi as it builds on its partnership with Translate Bio by launching dedicated vaccine R&D centers in Massachusetts and France. The French pharma giant announced plans today to invest €400 million ($475 million) annually into what it describes as its ‘mRNA Center of Excellence’ to accelerate R&D of next-generation vaccines. The ‘Center’ will in fact be spread across two of Sanofi’s locations, Cambridge (Boston) in Massachusetts and in Marcy L’Etoile (near Lyon), France,…

$250m CAR-T startup ‘validates’ Intellia’s allogeneic and CRISPR platforms

Intellia Therapeutics, Blackstone, and Cellex have launched a CAR-T biotech aimed at developing chimeric antigen receptor (CAR) T-cell therapies. The new company will combine Intellia’s allogeneic cell platform and CRISPR cell engineering with Cellex subsidiary GEMoaB’s switchable universal CAR-T platforms – UniCAR and RevCAR – to develop a range of therapies against various cancers, including solid tumors. Blackstone Life Sciences has invested $250 million in the new venture, and the three companies – Blackstone, Intellia, and Cellex – will each…

Vectorized antibody startup VectorY to establish Dutch plant

VectorY Therapeutics will use a portion of its recent €31 ($37) million seed financing to construct a plant in The Netherlands to support its vectorized antibody gene therapy candidates. The biotech, which launched in October 2020 at the Amsterdam Science Park in The Netherlands, secured €31 million through the funding round led by a syndicate that included Forbion, BGV, and Eli Lilly and Company. The money will be used to both establish preclinical proof of the firm’s concept for vectorized…

Enzymatic DNA printer will speed R&D and COVID testing, says DNA Script

DNA Script has launched a benchtop nucleic acid printer it claims will accelerate molecular biology, genomic research, and even COVID-19 testing. The Paris, France firm unveiled Syntax this month, describing it as a fully integrated, automated printer that is able to synthesize 96 DNA oligonucleotides in parallel, comprised of up to 60 nucleotides in length. The technology uses enzymes to synthesize the DNA molecules which – unlike traditional phosphoramidite chemistry based approaches – accelerates and optimizes production and eliminates the…

Dendreon leveraging Provenge network to launch cell therapy CDMO biz

Dendreon says its experience bringing Provenge to market puts it in good stead to offer its process development, manufacturing, and patient logistics capabilities to other cell therapy makers. Dendreon has had a turbulent past. Its autologous cell therapy product Provenge (sipuleucel-T) was approved in the US in 2010 for the treatment of prostate cancer but manufacturing complexities and costs led the firm to restructure itself in 2012, including selling its Morris Plains, New Jersey to Novartis. Then in 2014 Dendreon…