Author Archives: Dan Stanton

GSK opens $139m Benlysta expansion in Maryland

GlaxoSmithKline has increased drug substance capacity for Benlysta (belimumab) at its Rockville site. It is GSK’s second multi-million-dollar manufacturing project to open within a week In 2017, UK-headquartered Big Biopharma firm announced plans to invest $139 million (€126 million) at its site in Rockville, Maryland to increase the active pharmaceutical ingredient (API) manufacturing capacity for its lupus drug Benlysta. The project has now been completed, upping the Benlysta drug substance capacity at the facility by around 50%. According to Maryland…

From roller bottles to bioreactors: Rentschler building out ex-Shire MA plant

CDMO Rentschler is adding a 500 L single-use bioreactor at the plant it acquired from Shire in January and says further expansions will add manufacturing and lab capacity. Rentschler completed the acquisition of the Milford, Massachusetts biomanufacturing facility from the now defunct Shire in January 2019, marking its first step into the US. The German contract development and manufacturing organization (CDMO) makes the recombinant hemophilia A product Obizur form the facility for Takeda – which bought Shire earlier this year…

‘Unprecedented’ HPV vaccine demand to fuel more Merck capacity investments

Having recently invested over $1.6 billion in its network, Merck says it is committed to further expand the supply of its HPV vaccines as worldwide demand continues to spiral. Speaking at the at Morgan Stanley 17th Annual Global Healthcare Conference last month, Roger Perlmutter, EVP and president of Merck Research Laboratories, said human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 were the products that have the dominant near-term commercial potential for his firm. But a lack of manufacturing capacity at…

Biopharma continues to flex its Abs, survey shows

Results of KNect365’s Antibodies Emerging Tech Survey shows biopharma remains focused on monoclonal antibodies but acknowledges challenges persist, particularly in the discovery stage. There were over 200 respondents to the survey, with 81% of the organizations focusing on developing monoclonal antibody (MAb) therapeutics. This comes as no surprise, as the first Mab entered the market over 30 years ago in the form of Janssen-Cilag’s Orthoclone OKT3 (muromonab) and the modality has been deemed well-characterized by the US Food and Drug…

Moderna to expand mRNA plant with tech development center

Moderna will build an 85,000 square-foot technical development center at its recently opened manufacturing site in Massachusetts to support its messenger RNA (mRNA) pipeline. mRNA products themselves are neither small molecules nor traditional biologics, but rather a ‘set of instructions’ directing cells to, essentially, ‘use the human body as the bioreactor’ and make the proteins needed to prevent or fight diseases. Moderna Therapeutics has over 20 mRNA-based products in its pipeline, including prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology candidates, and…

Samsung BioLogics boost to cell line dev with patent win over Lonza

Lonza says it is “clearly disappointed” after the Intellectual Property Tribunal in Korea ruled in favor of Samsung BioLogics in invalidating a patent relating to cell line development. Samsung BioLogics challenged fellow contract development and manufacturing organization (CDMO) in July 2017 regarding Lonza’s patent 1302904, entitled ‘Mammalian Expression Vector Comprising the MCMV Promoter and First Intron of HCMV Major Immediate Early Gene.’ The patent relates to a vector for transferring a gene developed for producing an antibody into a cell…

Eppendorf invests €20m to expand German consumables plant

The Eppendorf Group says the expansion of its site in northern Germany will increase production capacity for life science consumables by around 30%. Construction of two production halls at Eppendorf’s site in Oldenburg in Holstein are set to begin next year in efforts to increase the firm’s laboratory consumables’ volume. Julie Brahms, a spokesperson from the firm, told Bioprocess Insider the expansion represents an investment of about €20 million ($22 million) and – from 2021 when production begins – will…

In the pipeline: Surge of cell and gene therapies likely in 2020

Over 20 cell and gene-based therapies are expected to be filed or to receive approval decisions over the next 18 months, according to the Alliance for Regenerative Medicine (ARM). Earlier this year, the US Food and Drug Administration (FDA) laid out its action plan to deal with the large upswing in the number of investigational new drug (IND) applications for cell and gene therapies it is receiving. “The FDA commissioner has anticipated that he thinks there will be between 10-20…

Yescarta 2.0? How Kite plans to scale out CAR-T therapies

CAR-T pioneer Kite Pharma says scaling out capabilities, embracing digital technologies, and industry collaboration are among the efforts needed to bring cell therapies to maturity. In 2017, Gilead company Kite Pharma became the second company to achieve US regulatory success for a chimeric antigen receptor (CAR) T-cell therapy. Two years on, and while sales of the product Yescarta (axicabtagene ciloleucel) are rising – Q2 2019 saw a 25% quarterly growth to $120 million –the sector itself has somewhat stalled with…

Treefrog wins EU funding for mass-produced cell therapy tech

Treefrog Therapeutics has received €10 million ($11 million) over the past five months to support its mass-produced pluripotent stem cell platform C-Stem. In September, Bordeaux, France-based Treefrog Therapeutics received €450,000 from the French government and €2.4 million from the EU’s Horizon 2020 program to help acelerate the cGMP certification and scale-up of its C-Stem technology platform. It comes five months after the firm raised €7 million in a Series A funding. “C-Stem is a technology that enables the mass-production of…