Author Archives: Dan Stanton

Kite on CAR-T: Growing sales, growing supply chain concerns

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Kite Pharma says it is looking to secondary suppliers and other risk mitigation measures to manage its cell therapy cold chain supply amid a growing production network. Since opening a 43,500 square-foot manufacturing plant in Santa Monica, California in 2016, Kite Pharma – and Gilead Sciences, which acquired the firm in October 2017 – has rapidly expanded its production network, to support supply of its chimeric antigen receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel). In May 2018, the firm opened a…

November 3, 2019

GSK Q3: Shingrix shines but adjuvant will drive future vaccines

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GSK says the adjuvant platform used in Shingrix will be the “backbone†of its future vaccine strategy. The shingles vaccine pulled in sales of £535 million ($693 million) for the third quarter. For the quarter, GlaxoSmithKline (GSK) reported group sales of £9.4 billion, up 11% on the previous year. Its vaccines unit grew 15% year-on-year to £2.3 billion with its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster), Shingrix, pulling in £535 million – up 76% year-on-year.…

November 1, 2019

Amgen takes $2.7bn stake in BeiGene to up presence in China

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Amgen will look to commercialize several of its biologics and advance 20 oncology candidates in China as it acquires roughly 20% of local drugmaker BeiGene. During Amgen’s third quarter 2019 financial call this week, CEO Bob Bradway noted his firm’s excitement of having recently launched its first product in China – cardiovascular disease monoclonal antibody Repatha (evolocumab). “We expect this to become an important market for us through time,†he told investors. Days later, and the biopharma firm has struck…

November 1, 2019

Abzena and MilliporeSigma up services on ADC outsourcing demand

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The high clinical failure rate of antibody-drug conjugates (ADCs) and the tendency to outsource development have driven both Abzena and MilliporeSigma to launch new service offerings. The first ADC, Wyeth’s Mylotarg (gemtuzumab ozogamicin) was approved in 2000, but nearly 20 years on there are only a handful of such therapies on the market. However, ADCs remain a viable and financially tempting oncology treatment and according to MilliporeSigma there more than 300 projects in development. Writing in ADC Directory earlier this…

November 1, 2019

Manufacturing assessments critical in ADC development, says AZ

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Manufacturing is key to bringing ADCs to the clinic faster says AstraZeneca, which stresses the importance of carrying out developability assessments. When a new molecule enters AstraZeneca’s portfolio, one of the first things the Anglo-Swedish biopharma firm does is carry out a developability assessment to understand the challenges in bringing the candidate through the clinic. Like other drug developers, the firm has a series of processes to move a project from lead optimization to candidate profiling, before moving into the…

November 1, 2019

Bio-Techne confirms $50m reagents plant to support CGTs

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Bio-Techne will build a 50,000 square-foot plant in Minnesota with an initial capacity of $140 million of E. coli-derived recombinant proteins to support cell and gene therapy developers. After months of talk, life sciences services and consumables firm Bio-Techne has laid concrete plans to build a facility in St Paul, Minnesota to produce GMP reagent proteins for use in cell and gene therapy applications. “The facility is expected to go through qualifications in approximately one year, with commercial sales expected…

October 29, 2019

Supplier relationships critical in driving process intensification, says BMS

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Process intensification is driving down costs in the biologics space, but manufacturing firms need to treat vendors like partners and not simply suppliers, says Bristol-Myers Squibb. Process intensification emerged as one of the hot topics at Biotech Week Boston last month. There were multiple talks and discussions looking at strategies such as perfusion-based cell culture, multicolumn chromatography in the downstream, and the increased use of analytical technologies aimed at intensifying manufacturing processes. Ciaran Brady, executive director of Manufacturing, Science and…

October 29, 2019

Thermo Fisher: ‘Bio market is good but our position is better’

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Thermo Fisher has reported another quarter of double-digit in its life sciences division attributing its competitive strength to its diversified offering. For the third quarter 2019, Thermo Fisher reported sales of $6.3 billion (€5.7 billion), up 6% year-on-year. Within the firm’s Life Sciences Solutions Segment division, which includes bioprocess equipment and its biomanufacturing business, revenues grew 13% to $1.7 billion. Last quarter, analysts claimed the “bioprocessing ecosystem [was] on fire,†and another period of double-digit growth, for Thermo Fisher at…

October 29, 2019

Skids and resins: Pall divulges more on Sartorius divestment

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In a letter to customers, Pall Corporation has revealed the exact businesses and products it is selling to Sartorius to facilitate Danaher’s acquisition of GE Biopharma. Last week, Danaher Corporation announced plans to divest parts of its bioprocessing businesses to help facilitate the $21.4 billion (€19.2 billion) takeover of GE Healthcare’s Life Sciences business. The firm said rival bioprocess vendor Sartorius is in line to pick up its biomolecular characterization business FortéBio, its SoloHill microcarrier technology unit, and various chromatography…

October 25, 2019

WuXi selects Irish site for first vaccine plant

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Chinese CDMO WuXi Biologics has laid plans to build a manufacturing facility in County Louth, Ireland, months after forming a vaccine joint venture. In May, WuXi Biologics formed a joint venture with Shanghai-based Hile Bio-Technology to service a 20-year manufacturing contract with an undisclosed vaccine developer estimated to be worth more than $3 billion (€2.7 billion). At the time, the Chinese contract development and manufacturing organization (CDMO) said it was scouting for a dedicated vaccine manufacturing site, and it turns…

October 23, 2019