Therapeutic Class

GSK to ramp-up Shingrix vaccine as demand outstrips supply

GSK says it is pleased with the launch of its shingles vaccine Shingrix but supply going forward is limited by a lack of manufacturing capacity. In October 2017, GlaxoSmithKline received approval from the US Food and Drug Administration (FDA) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted), its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). A year on, the Big Pharma firm announced Shingrix sales of £286 million ($372 million) for its third quarter, helping to boost its…

High Octane: Lonza buys 80% of ‘game-changing’ cell therapy tech partner

Lonza has acquired a controlling stake in its partner Octane Biotech and will incorporate the closed and automated Cocoon processing tech into its autologous cell therapy offering. Contract development and manufacturing organization (CDMO) Lonza has collaborated with Octane Biotech for the past three years to develop the Cocoon manufacturing system. But this week, the Swiss CDMO purchased additional equity to hold a controlling stake of 80% in the firm, with an option for outright ownership. “Owning a controlling stake ensures…

Samsung Bioepis riding the biosimilar third wave

Samsung Bioepis has beefed up its biosimilar pipeline with versions of Lucentis (ranbizumab) and Soliris (eculizumab) under development. In Europe, South Korean biopharma firm has achieved commercial success with four biosimilar products. In the US – through commercialization partner Merck & Co. – it has launched one and has two other biosimilars under review. When looking at the market and large pharma biosimilar makers such as Pfizer and Sandoz “we are up to par with the ‘big boys’ in terms…

Turning of the tide: High potential for oligos, says survey

Within the tides space, oligonucleotides hold the most opportunity for commercial success and growth say respondents of a KNect365 survey. The oligonucleotide therapeutic market could be viewed as having suffered a false start. The potential of antisense oligonucleotides to silence specific genes was jumped upon in the 1980s with numerous companies investing heavily in the field and commencing hundreds of clinical trials. However, the unexpected complexity of oligonucleotide pharmacology somewhat dampened the sector. And though the US Food and Drug…

Janssen closing in on ‘holy grail’ through $82m HIV vaccine plant

Janssen has opened a single-use manufacturing facility in Leiden, the Netherlands to support the commercialization of its preventative HIV vaccine candidate. Commissioned in 2014, the multipurpose vaccine production facility is being inaugurated today (Thursday October 25) in Leiden, the Netherlands and will initially be used to manufacture the firm’s investigational mosaic HIV-1 preventive vaccine. The facility represents an investment of €72 million ($82 million). The facility came about following the 2014 Ebola outbreak in West Africa, Dirk Redlich, VP of…

Novartis growing CAR-T network amid slow Kymriah sales

Novartis says it remains confident Kymriah will pull in $200 million in 2019 through the remediation and ramp-up of its CAR-T manufacturing network. For the third quarter 2018, Kymriah (tisagenlecleucel) netted Novartis $20 million (€17.4 million), making a total of $48 million for the first nine months of the year. The product became the first chimeric antigen receptor (CAR) T-cell to be approved in August 2017. Elizabeth Barrett, chief executive officer of oncology at Novartis, said the sales figures were…

Roche ups cell therapy interest through SQZ expansion deal

Roche has expanded its partnership with SQZ Biotechnologies to codevelop therapeutics derived from peripheral blood mononuclear cells (PBMCs) in a deal worth up to $1 billion. In 2015, Swiss Biopharma Roche partnered with SQZ to use its B cell engineering technology in the development of cell therapies for cancer. This week, the firm has expanded the partnership to jointly develop and commercialize products based on antigen presenting cells (APCs) created by the SQZ platform. “SQZ entered into a first collaboration…

MaSTherCell wins Iovance deal as commercial cell therapy demand increases

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…

Aglaris talks automated and closed cell therapy platform

Anglo-Spanish firm Aglaris has developed an autonomous, closed production system for the manufacture of cell therapies such as T-cells and MSCs (Mesenchymal Stem Cells). According to new CEO Steven Docksey, the platform overcomes many issues associated with this new product class. “Most current processes are intensive, manual techniques derived and scaled-up from the cell preparation techniques used in research labs – adapting existing tools to the job. There is little in the way of genuine innovation that has come to…

Novartis’ Kymriah partner doubling capacity on global viral vector demand

Oxford BioMedica – the sole manufacturer of the lentiviral vector for CAR-T Kymriah – will up capacity with a fourth facility to support future platform and pipeline deals. Oxford BioMedica, has signed a fifteen year lease on a new facility at its site in Oxford, UK-based, which when operational will more than double the firm’s bioprocessing capacity. The 7,800m2 facility – the fourth plant at the site – will contain four GMP clean room suites and two fill and finish…