Implementing Review-By-Exception RtReports For Manufacturing At BioMarin

By Nick Monteleone and Travis Pereira, BioMarin Pharmaceutical

BioMarin Pharmaceutical — a company focused on developing and manufacturing therapeutics for patients with rare genetic diseases — faced a common industry issue: batch release pressure. Are reports showing all needed information? Is non-critical data included in the reports? Are we releasing the batch as soon as possible?

Serving markets that offer few, if any (in some cases), alternative treatment options, BioMarin always has considered its products’ speed to market critical. To this end, the company has sought ways to drive improvement in both its quality and manufacturing operations. One such initiative was an effort to streamline its batch review process.