Friday, May 17, 2019 Daily Archives

Pfizer urges FDA for flexibility in considering interchangeability studies

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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…

May 17, 2019

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

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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…

May 17, 2019

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

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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…

May 17, 2019