Is Product Analysis of Biologic-based Pharmaceuticals a Bottleneck in Production?
With our products, we help protect your customers while keeping your operations compliant and improving the bottom line.
The BACT/ALERT® 3D was developed as an effective and safe solution for industrial sterility testing.
BIOBALL® Standardized Strains
BIOBALL® is a small water-soluble ball containing a precise number of microorganisms that delivers accuracy and precision, batch after batch.
BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.
ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.
The phenomenon of Low Endotoxin Recovery (LER) has gained renewed attention in the scientific community in recent years as the FDA now requires that all new Biological License Applications are able to successfully unmask when LER occurs. ENDOXPERTS™ is our solution for unmasking LER, which helps you meet regulatory requirements.