Confident Compliance

The rapid time-to-result and flexibility of the Octet platform has helped accelerate almost every stage of the drug development workflow in leading and start-up biotherapeutic companies. New comprehensive tools for compliance now enable application of Octet systems to be easily integrated in analytical development and regulated GxP labs. Multiple applications, including lot release and in-process testing for ligand binding, concentration and impurity analysis (HCP, residual protein A) are increasingly being run on Octet systems. These systems have also become a solution platform for potency analysis of drug-target and drug-Fc receptor(s) (FcγRI, FcγRIIa, FcRIII and FcRn) interactions. For more information, please see GxP applications.

Octet systems have been developed to operate in a regulated environment, with available installation and operational qualification services, maintenance support and 21 CFR Part 11-compliant software tools.

ForteBio - GxP

Comprehensive Qualification and Validation Service Offering

An optional GxP package is available for the Octet RED96e, RED384 and HTX systems to easily integrate these systems into your GxP workflow. The GxP package includes the following:

  • Installation and Operational Qualification (IQ/OQ) Kit and Services
  • Performance Qualification (PQ) Kits (available on the Octet RED96e system only)
  • Octet CFR Software
  • Software Validation Package Support
  • Exceptional Technical Support Assistance

IQ/OQ

The IQ/OQ Kit provides comprehensive documentation and operational assessment to verify that the Octet instrument, accessories and computer system are supplied, installed and operates as intended.

PQ

The PQ Kit provides a rapid and convenient method to verify performance of your Octet RED96e instrument. The kit is a two-component performance qualification kit; the PQ-Kinetics assay verifies signal levels, signal precision, and kinetic (ka, kd) and affinity (KD) constants are within specification for an antibody-antigen binding interaction, and the PQ-Quantitation assay verifies signal levels, sample recovery, and precision are within specification in a two-step binding assay for quantitation.

Biosensor Validation

Pall ForteBio also offers biosensor validation services for GMP users. This service is designed to provide users with multiple lots of select biosensors for method qualification and validation purposes.

Octet CFR Software and Software Validation Package

Octet CFR software includes 21 CFR Part 11 compliant features such as controlled user access, comprehensive audit trails, customized locked reports and electronic signatures. All data acquired by the software is digitally signed to protect data integrity. For researchers working in GxP laboratories, the Octet Software Validation Package provides comprehensive documentation and tools to validate the ForteBio FB Server Monitor and Octet CFR software features and functions. It trims validation time to just three days using a fully-integrated software tools that mirror the validation process in a regulated laboratory.