German drugmaker Boehringer Ingelheim has developed a way of managing biomanufacturing that can be applied to any single use production platform on the market.
The approach – which will be available to all the firm’s contract biomanufacturing customers – will allow clients to set-up different commercially available systems under the same roof, all operated by the same experts.
Boehringer says the platform, which will be based in its mammalian facilities, means seamless process transfers. It is part of its “Lean-to-Clinic” program, which aims to advance from gene to drug product in 16 months.
“We have gathered years of experiences from different single use systems in our expert groups and could therefore form a truly unique single use platform for upstream- and downstream processes,” said Hitto Kaufmann, VP of process science, Germany.
Cambridge Major Laboratories (CML) has expanded its active pharmaceutical ingredient (API) facility in Germantown, Wisonsin, in what it says is a response to a boom in demand for late phase clinical production services.
Under the plans, the company will add “significant” extra reactor capacity and isolation equipment.
Brian Scanlan, president and CEO said the undisclosed investment is a bid to meet an industry demand for speedy manufacturing in late phases.
“By making these new investments, we show our commitment to support our loyal client base at the most critical point, when quality and timely delivery are imperative,” he said.
B. Braun Group has completed a new 98,000 sq ft parenteral solutions factory in Barcelona, Spain.
The facility includes three continuous processing production lines which operate around the clock, including four 30,000ltr manufacturing tanks, two 15,000ltr tanks and three bottling lines.
It works on lean infusion factory technology (LIFT).