Baxter says there is a trend towards outsourcing for cytotoxic manufacturing as it begins further expansion of its German plant.
A €58m ($77m) investment will see 1750m2 of extra capacity being added to the fill/finish contract manufacturing facility in Halle, Germany as Baxter International responds to an increase in demand for cytotoxicity manufacturing.
Speaking with Outsourcing-Pharma.com, Dr. Burkhard Wichert - Vice president of Manufacturing for Baxter’s BioPharma Solutions – said that cytotoxic therapies are currently in strong demand and that further investment in Halle would fulfill the manufacturing needs of Baxter’s clients.
Wichert added that generally there has been “an increasing trend towards outsourcing in general, particularly in the segment of parenteral cytotoxics.”
Baxter is planning to install new commercial and clinical filling lines and three freeze dryers at the plant, in a project expected to be completed in 2015. The news comes just eighteen months after additional freeze-drying capacity was added at the site, itself only a year apart from a prior lyophilisation expansion .
The revamp will see workforce increase by approximately 10 percent. According to Wichert: “We expect skills to increase and evolve in manufacturing as well as other functional areas in order to continue to provide state-of-the-art manufacturing.”
Cytotoxic & ADC Investment
Baxter is already manufacturing ADCs for some clients at Halle and the new building will add further capacity to its ADC manufacturing offerings.
ADCs are monoclonal antibodies designed to combine the highly potent, normally intolerable, anticancer cytotoxic molecules in order to target specific cancers.
As cancer cases continue to increase, CMOs (contract manufacturing organisations) look to offer their clients a number of different manufacturing solutions and recently there has been an industry trend towards ADC production.
Lonza announced in January that it was to revamp its Visp, Switzerland plant in order to double ADCs production, investing CHF14m ($15.1m) and offering a number of new jobs in order to “establish additional high-tech
Though investment is high, there is at present only one ADC approved in the US (following the withdrawal of Pfizer’s – formerly Wyeth’s - leukemia drug Mylotarg in 2010). Last October, the European Medicines Agency approved a conditional marketing authorisation for the continents first ADC, Adcetris, marketed byTakeda Global Research & Development Centre (Europe).
This article was updated on February 20 following confirmation that Halle manufactures ADCs from Baxter.