Aprecia boosts 3D printing facilities at new US site
pharmafile | August 11, 2015 | News story | Manufacturing and Production, Research and Development |
Aprecia Pharmaceuticals, which scored a world-first by becoming the first manufacturer to gain FDA approval for a three-dimensional printed (3DP) pill, is building a new factory to scale up its production capability using the technology.
Earlier in August, Aprecia became the first pharma company to earn FDA approval for a 3D-printed drug for medical use. The company’s epilepsy treatment Spritam (levetiracetam), which is expected to launch in Q1 2016, was created using Aprecia’s ZipDose technology.
This technique prints in layers to produce a highly porous formulation that rapidly disintegrates when taken with just a sip of liquid, potentially helping people with swallowing disorders. This allows Spritam to be used by patients prescribed high dosages, as the drug can be absorbed into the blood stream in as little as 10 seconds.
Aprecia says the process “stitches together multiple layers of powdered medication using an aqueous fluid to produce a porous, water-soluble matrix that rapidly disintegrates with a sip of liquid.” Aprecia says its technology allows for delivery of a high drug load, up to 1,000 mg, in a single dose.
Now the Pennsylvania-based firm is building a new manufacturing facility in Blue Ash, Ohio, to increase the output of its 3DP technology which it will use to make quick-dissolve, easily ingested formulations of highly prescribed high-dose medications.
“Having evaluated a number of options for reaching our long-term commercial manufacturing goals, Aprecia believes that the state of the art facility in Blue Ash, Ohio, is particularly well suited to showcase our proprietary 3DP technology platform,” says Don Wetherhold, Aprecia’s chief executive. “The facility has ample space to accommodate our proprietary manufacturing machines and equipment assemblies in the capacity necessary to achieve our projected commercial production volumes well into the future.”
Aprecia plans to invest $25 million in the 190,000-square-foot facility, where its pharmaceutical manufacturing will occur, which will bring 150 new jobs to Blue Ash. Aprecia is expected to move into the building in the next few months.
Lilian Anekwe
