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Vaccine Safety Testing Services 

AppTec provides comprehensive testing programs for viral (live, attenuated, and inactivated), whole cell, peptide and recombinant protein vaccines.  With well-equipped laboratories and an experienced, dedicated staff, AppTec will work with you to design custom biosafety testing assays to meet worldwide regulatory guidelines.  

Testing Programs for Human and Animal Vaccines 

(in accordance with 21 CFR, the European Pharmacopeia, and 9 CFR)

Comprehensive biosafety testing for raw materials, cell culture, virus, subunits, manufacturing processes and final product.  

Comprehensive Characterization of:

     Cell BanksVirus Stocks

     Virus Harvests

     Control Vessel Cultures

     Production Vessel Cultures

     Final Product  

Custom Validation of Manufacturing Processes To Inactivate or Remove Virus

Scale-down of manufacturing process, well-characterized, high-titer virus stocks, validated assays, quantification of virus inactivation and clearance, and custom controls to ensure rigorous and scientific results.  

Characterization of Recombinant Vaccines

Analytical, molecular, biological and immunological testing is available to evaluate product characteristics and safety profile.  Cell line tumorigenicity/carcinogenicity is also available.  

Technical and Regulatory Guidance on Cell Line and Product Testing

AppTec's Technical Services provide technical and regulatory guidance to support your product development process.