Global Markets

Boston next-gen manufacturing hub will ease bottlenecks, consortium

Cell and viral vector backlogs reduce patient access to next-generation medicines and slow R&D says the consortium behind a $50 million innovation hub. The group, led by Harvard University, made the comments this week, explaining that while some contract development and manufacturing organizations (CDMOs) offer cell line and vector services, growing demand means developers can face delays. “Manufacturing backlogs are slowing the production of cells that are essential to research, holding up the availability of new treatments headed for the…

Lack of UK cell and gene therapy skills a concern according to CGTC survey

UK cell and gene therapy firms are worried a shortage of skilled manufacturing staff will slow growth with some concerned Brexit will exacerbate the problem. The findings come from a new skills survey by the Cell and Gene Therapy Catapult (CGTC) – an organisation set up to support the sector by non-departmental government body, Innovate UK. Of the 41 companies that responded, 98% said they planned to expand their headcount over the next five years. Of these, 83% raised concerns…

CBMG hopes to bring China success to Maryland but is it late to the CAR-T party?

Cellular Biomedicine Group (CBMG) says it hopes to leverage R&D work done in China to expedite clinical trials in the US as it establishes facilities in Maryland. Last month, Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) announced plans to build a 22,000 square foot facility in Rockville, Maryland. The site will be the first outside China for the firm and is intended to initially support US clinical trials for its cell-based candidates targeting hematological indications. Speaking on its Q3 2019 conference…

China: Stainless-steel will shine as market moves to commercial

There has been a barrage of investment in flexible single-use capacity in the burgeoning China market. But as the sector matures and projects move to commercial, developers are likely to opt for fixed stainless-steel facilities, says BioPlan Associates. Biomanufacturing in China is blossoming, driven by changing regulations and a surge in investment, which have created a pathway for Market Authorization Holders (MAHs) and domestic third-party manufacturers alike. In the recent CPhI Worldwide annual report, Vicky Qing XIA, senior project manager…

German plant fastest option to make approved Ebola vaccine, says Merck

Merck & Co expects to complete production of the first batches of Ervebo – its newly EC-licensed Ebola vaccine – at its Burgwedel plant by late 2020. The European Commission (EC) granted Ervebo conditional marketing authorization for the active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus this week. The decision was based on data submitted for accelerated assessment in March. Merck – which is known as…

Who got the Funk? Not Lonza, as CEO unexpectedly quits

Marc Funk has stepped down from his position as CEO after only nine months and is leaving Lonza, citing personal reasons. Marc Funk was made CEO of Swiss contract development and manufacturing organization (CDMO) Lonza in March this year, after his predecessor Richard Ridinger retired following a seven-year tenure. But just nine months on, Lonza has announced Funk is leaving the company “for personal reasons,” handing the CEO baton to chairman Albert Baehny on an interim basis until a permanent…

Aspen alert! Novartis buys assets for $330m in Japan boost

Novartis division Sandoz has acquired the Japanese business of Aspen Global Incorporated (AGI), bolstering its biosimilar and generics presence in the region. South African pharma firm Aspen Holdings opened the Japanese subsidiary Aspen Japan K.K. in May 2015, with an aim bring its oncology, immunosuppressant, anti-inflammatory, hypertension, and anticoagulant products to the market. Today, Sandoz, the generics and biosimilar division of Swiss Biopharma firm Novartis, has announced it will pay an initial €300 million ($330 million) to buy shares in…

Biomanufacturing capacity: 45% growth but new blockbusters could leave shortage

Biomanufacturing volumes are set to increase by 45% to 6,400 kL over five years. But with demand growing at over 10% per year and the potential arrival of Alzheimer’s MAbs, there may still be a shortage in capacity. In a report published in conjunction with the CPhI Worldwide meeting in Frankfurt, Germany this week, Dawn Ecker, director of bioTRAK Database Services, BioProcess Technology Group, BDO, spoke of the current capacity availability within the biologics industry and potential restraints in the…

GSK Q3: Shingrix shines but adjuvant will drive future vaccines

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.…

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

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…