Central to managing and improving antibody standards is our use of a quality management system that helps us to record and monitor appropriate data and control changes in our manufacturing processes.
Our RabMAb® manufacturing sites are ISO 9001:2015 certified, and all other sites follow the same guidelines
Our IHC reagents business in California is registered with the US Food and Drug Administration (FDA) and operated under FDA Quality System Regulation (21 CFR Part 820) in compliance with ISO 113485:2003. In addition, this facility and its quality system has a Medical Device Manufacturing License granted by the California Department of Public Health (CDPH)
Several of these reagents are analyte specific reagents (ASRs) (eg against Hepatitis B Virus Core Antigen, Adenovirus, CMV, and others) and are produced under good manufacturing practices (GMP)
In addition to the portfolio of ASRs under our own brand, we have supply or license agreements with more than 80% of leading global diagnostics platform companies, for supply and/or license of GMP grade abs as raw material for inclusion in in vitro diagnostic (IVD) tests ranging from LDT to Class I companion diagnostics
We conduct regular internal audits and welcome customer audits from our industrial partners
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