Author Archives: Dan Stanton

German pandemic prep wins for GSK, CureVac, Wacker, and more

As part of a pandemic preparedness plan, Germany has struck several deals to secure manufacturing capacity for hundreds-of-millions of doses of mRNA-based vaccines. To support the continued COVID-19 pandemic and to be better prepared for future health crises, Germany has secured messenger RNA (mRNA) vaccine manufacturing capacity across a range of partners. The first deal, announced last week, sees German vaccine maker BioNTech reserve and maintain manufacturing capabilities to produce at least 80 million mRNA-based vaccine doses per year for…

Samsung Bio spending $347m to buy land for Biocampus 2

CDMO Samsung Biologics has agreed to buy land close to its site in Songdo, Korea for future greenfield projects including capacity expansions. Samsung Biologics has grown over the past decade into one of the largest biologics contract development and manufacturing organization (CDMO), with three operational facilities at its biocampus in Songdo, Incheon boasting a total of 364,000 L of mostly stainless-steel bioreactor capacity. A fourth ‘super plant’ under construction will add a further 256,000 L of capacity, and a future…

MAST away: Lonza sells bioreactor sampling tech to MilliporeSigma

MilliporeSigma says the addition of the MAST (Modular Automated Sampling Technology) platform will help its customers optimize their bioprocesses and speed up development time. Lonza is offloading the platform to bioprocess vendor and fellow contract manufacturer MilliporeSigma – the life sciences service division of Germany’s Merck – for an undisclosed fee. The technology provides biomanufacturers near real-time sampling and analysis of bioreactors, the results of which can be used to deliver a range of analytical devices measuring titer, metabolites, and…

Alnylam RNAi candidate delayed due to packaging CDMO issues

Alnylam says an inspection at a secondary packaging facility run by a third-party has pushed the FDA’s approval date for vutrisiran back three months. Alnylam Pharmaceuticals is a pioneer in the RNAi space, becoming the first company to bring a small interfering ribonucleic acid (siRNA) treatment to the market with Onpattro (patisiran), approved by the US Food and Drug Administration (FDA) in August 2018. Since then, the firm has achieved success with Givlaari (givosiran) and Oxlumo (lumasiran) but has suffered a…

Buoyant ADC market drives Sterling expansion

A year after acquiring ADC Bio, Sterling Pharma is expanding its Deeside, UK facility to better serve the growing antibody-drug conjugate (ADC) market. Sterling entered the ADC space in April 2021 through the acquisition of ADC Bio. The deal brought with it a 6,500 square-meter site in Deeside, Wales housing ADC and bioconjugation development laboratories. A year on and Sterling is committing a further £1 million ($1.3 million) to the site, increasing laboratory space from 275 to 419 square meters,…

Insider State of the Industry: Ukraine, supply chains, and CDMO gains

Another quarter, another industry snapshot. We sat down with experts at BPI West to discuss the current state of biomanufacturing. Our State of the Industry series began last year to allow reflection on quarterly trends within the bioprocess and manufacturing sector. Clearly the pandemic has driven much of the conversation, but in a sign of COVID’s decline this quarter’s panel was held not on Zoom, Teams, or Skype but in a real face-to-face setting: BPI West in San Diego. Our…

Catalent injecting $160m into UK Government’s failed vaccine plant

CDMO Catalent has picked up the UK taxpayer-funded Vaccine Manufacturing & Innovation Centre (VMIC) for an undisclosed fee. In early 2020 as the COVID-19 pandemic hit, the UK Government’s Vaccine Taskforce invested around £200 million ($270 million) into a facility aimed at addressing the country’s lack of vaccine manufacturing capacity. The 74,000 square-foot VMIC in Harwell, near Oxford – about 50 miles west of London – had been expected to offer up to 70 million doses of pandemic vaccine, deliverable…

Novartis’s $115m pays off as FDA approves second Zolgensma site

The Novartis facility in North Carolina will begin shipping Zolgensma gene therapy doses immediately after receiving US FDA commercial licensure approval. The Swiss Big Pharma firm announced yesterday the US Food and Drug Administration (FDA) has granted approval to its multi-product gene therapy manufacturing facility in Durham, North Carolina. The 170,000 square-foot facility site will primarily be used to produce Zolgensma (onasemnogene abeparvovec. Novartis added Zolgensma to its pipeline through the $8.7 billion acquisition of AveXis in May 2018 and…

Bayer on keeping CGT acquisitions at arm’s length

Keeping biotech bolt-ons separate from its main organization is essential in retaining agility, speed, and innovation for cell and gene therapies, says Bayer’s Jens Vogel. Despite relatively few reaching commercialization, cell and gene therapies (CGTs) have become a solid part of the wider pharmaceutical landscape with numerous big firms dabbling in the sector. German biopharma giant Bayer became a serious fixture in the advanced therapy space in 2019 when it bought out cell therapy developer BlueRock Therapeutics. The following year,…

Merck completes $1bn HPV vaccine expansion in Virginia

Merck & Co. has added 120,000 square feet of manufacturing capacity at its Rockingham County site to support continued scale-up of its Gardasil HPV vaccines. Human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 pulled in $1.5 billion for Merck last year, and while the firm has predicted sales to double by 2030 as demand continues, this is reliant on having the manufacturing capacity in place. With this in mind, it is good news today for Merck as it announces the…