Author Archives: Dan Stanton

Regenxbio building Maryland AAV plant to support gene therapies

Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform. The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021. “The creation of this additional manufacturing capacity using our platform suspension cell culture process will allow us to more efficiently…

Thermo Fisher $50m spend to support high single-use uptake

Single-use adoption has gone from niche applications to standard practice in biomanufacturing says Thermo Fisher, which is expanding its disposable capabilities. Thermo Fisher has laid down plans to expand its bioproduction equipment capacity through a $50 million (€45 million) investment on the back of growing demand for its single-use bioprocess container (BPC) systems. “The majority of our 2019 investment will be across our SUT [single-use technology] network in the US, and nearly $10 million will be spent specifically at our…

WuXi scouts single-use site for Chinese vaccine joint venture

WuXi Biologics has formed a vaccine production division to service a $3 billion strategic partnership with an unnamed global pharma. WuXi Vaccines is a joint venture between contract development and manufacturing (CDMO) WuXi Biologics and Shanghai-based Hile Bio-Technology. The new entity has been formed to service a Letter of Intent (LOI) inked with a multinational vaccine company. The client has not been disclosed, but WuXi Biologics CEO Chris Chen told Bioprocess Insider the strategic partnership will allow the vaccine developer…

German Merck: Continuous is key for bioprocess future

Merck KGaA reports a 15% year-on-year growth in its Process Solutions business and looks to its next-generation bioprocessing platform BioContinuum to continue the momentum. For the first quarter 2019, Germany’s Merck saw net sales within its life science business of €1.7 billion ($1.9 billion), up from €1.5 billion in the same period last year. The firm’s Process Solutions unit – which includes MilliporeSigma – however, saw a 15.1% year-on-year growth driven by bioprocessing demand, equating to €700 million. Merck’s results…

OPUS focus: Repligen expands to support chromatography demand

Bioprocessing vendor Repligen will add eight manufacturing suites to keep ahead of demand for its large-scale OPUS prefilled chromatography columns. During Repligen Corporation’s first quarter conference call, CEO Tony Hunt reported “another great quarter” for its OPUS pre-packed chromatography columns business, with sales up over 40% year-on-year. The firm did not break down how much the business brought in, but total sales at Repligen for the quarter reached $60.6 million (€54 million), up 35% on the same period 2018. “The…

Antibody–Drug Conjugate News: From BioProcess Insider

The following news items have appeared on the BioProcess Insider site over the past year. Together they indicate the direction in which the ADC sector is moving. BEYOND ADCETRIS — SEATTLE GENETICS AIMS FOR BIG BIOPHARMA STATUS 30 April 2018: Seattle Genetics is building toward a bigger future. For the first quarter 2018, the company’s total revenues grew to US$141 million (€116 million) compared with $109 million in the same period last year. This was attributed to a 36% increase…

Pfizer urges FDA for flexibility in considering interchangeability studies

The US FDA has published long-awaited final guidance on the interchangeability of biologics, calling biosimilar developers to carry out switching studies. At the last count, there were 19 biosimilar products approved by the US Food and Drug Administration (FDA) US though only a handful have been launched. None of these products have been deemed interchangeable, meaning they cannot be substituted for the reference biologic at the pharmacy level without the involvement of a physician. However, this theoretically could change going…

Training and ‘sea turtles’ support WuXi Biologics’ growing China footprint

WuXi Biologics talks Chinese talent recruitment as it begins building an eighth biomanufacturing facility in the country, this one with 48,000 L of single-use bioreactor capacity. The latest addition to contract development and manufacturing organization (CDMO) WuXi Biologics’ bioproduction network is a 1.3 million square-foot center in Chengdu, Southwest China. The facility will include drug development and commercial manufacturing capabilities and boast 48,000 L in bioreactor capacity. According to CEO Chris Chen, the capacity breaks down to 12 x 4,000…

Cryoport acquires Cryogene for $20.5m, adds Texas biostorage site

The combination of cold-chain logistics and biostorage places Cryoport in good stead for the arrival of allogeneic cell therapies, an analyst says. Cryogene’s proximity to Lonza’s Houston site is also a boon. Cryoport, a provider of temperature-controlled logistics solutions specifically in the cell and gene therapy space, paid $20.5 million (€18.3 million) in cash for Houston, Texas-based biostorage and biobanking firm Cryogene. Cryogene brings a 21,000 square-foot biostorage facility – which specializes storing biological specimens, materials and samples – to…

ElevateBio proposes centralized model for cell & gene startups

Neither a CDMO nor an end-user, ElevateBio is looking to change the paradigm in cell and gene therapy development through it’s a centralized R&D and manufacturing model. Recently launched through a $150 million (€134 million) Series A financing, ElevateBio intends to create and grow a portfolio of cell and gene therapy companies using shared expertise and facilities through its R&D, process development and cGMP manufacturing subsidiary Basecamp. “BaseCamp is not a CDMO [contract development and manufacturing organization],” ElevateBio’s CEO David…