GLP

Virovek’s GLP-grade production is compliant with the Food and Drug Administration’s Code of Federal Regulations, Title 21, Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies.

GLP Production Capabilities

Plasmid DNA, bacmid construct, recombinant baculovirus, rAAV
Ready for seed stock banking to GMP manufacturing (Virovek product can easily be made to fit GMP standards)
Annual GLP trainings
Audits by third parties
Optional purification system (ion exchange chromatography) to accelerate downstream development

Quality Assurance Oversight

Study Report

Strategies used
Batch records
Certificates of analysis
Sequences

Signed GLP Compliance Statement

Provided by the study director

Study Archival

5 years minimum