1. Residual DNA quantification in clinical batches of BBG2Na, a recombinant subunit vaccine against human respiratory syncytial virus
- Author
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Livia Lannes, Edith Julien, Jean-Yves Bonnefoy, Thien Ngoc Nguyen, Alain Beck, Christine Klinguer-Hamour, Delphine Picot, and Maryline Lokteff
- Subjects
Protein subunit ,DNA, Recombinant ,Dot blot ,Bioengineering ,Biology ,medicine.disease_cause ,Applied Microbiology and Biotechnology ,Virus ,law.invention ,chemistry.chemical_compound ,Antigen ,law ,medicine ,Escherichia coli ,Humans ,Pharmacology ,Clinical Trials as Topic ,Vaccines, Synthetic ,General Immunology and Microbiology ,Nucleic Acid Hybridization ,Viral Vaccines ,General Medicine ,Virology ,Molecular biology ,Biopharmaceutical ,chemistry ,Luminescent Measurements ,Recombinant DNA ,Drug Contamination ,DNA ,Biotechnology - Abstract
BBG2Na, a well-defined recombinant protein produced in Escherichia coli, is a promising human respiratory syncytial virus subunit vaccine candidate. This study describes the quantification of residual DNA in large scale batches used in phase I to III clinical trials. Two different analytical methods were developed and applied on five different final bulks of Drug Substance and their associated in process control samples, namely a chemiluminescent hybridisation assay and the total DNA Threshold System assay. These two complementary methods demonstrated the clearance of residual DNA during the downstream purification process. The amount of residual DNA found in the final bulks was below 20 pg of DNA per 300 microg BBG2Na, the highest tested clinical dose of antigen. This is very low level of residual DNA for a recombinant subunit vaccine produced in a bacteria and contribute to make for BBG2Na a well-characterised biopharmaceutical. This study also provides data concerning the validation of the hybridisation dot blot assay and the total DNA Threshold(trade mark)assay.
- Published
- 2001