Comprehensive compliance support
Saves significant time during validation procedures
High level of in-built GLP/GMP/GCP support for 21 CFR Part 11 compliance
Package includes GxP software, documentation and validation support
Read more details here
Newly developed tools to support immunogenicity testing
Supports screening, confirmation and characterization of anti-drug antibodies (ADAs)
Addresses drug interference by enabling detection & measurement of ADAs in the presence of drug
Includes guidance for development of immunogenicity assays
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