Quantification of vaccine compositions

摘要

The invention provides methods and mass-labeled peptides for use in said methods for quantifying the presence of a one or more viral proteins in a sample of a preparation containing agents which bind to said viral protein, using mass-spectroscopic analyzes of the sample and standards containing known amounts of labeled and unlabeled signature peptides, in particular wherein said viral proteins are antigens in a vaccine for porcine circovirus.

主权项

1. A method of quantifying the presence of one or more PCV2 viral proteins forming a virus like particle in a sample, the method comprising:
a) adding a known quantity of one or more stable-isotope-labeled signature peptides specific to the one or more PCV2 viral proteins in the sample, wherein the one or more stable-isotope-labeled signature peptides are selected from the group consisting of: NVDHVGLGTAFENSK (SEQ ID NO: 4), FNIDDFVPPGGGTNKISIPFEYYR (SEQ ID NO: 7), and VEFWPCSPITQGDR (SEQ ID NO. 24); b) digesting the sample with a protease; c) running mass-spectroscopic analyses of the sample; and d) determining an amount of the one or more PCV2 viral proteins in the sample, wherein the one or more PCV2 viral proteins are capable of forming a virus like particle and/or wherein the sample comprises virus like particles composed of a plurality of the one or more PCV2 viral proteins comprising PCV2a ORF2 and/or PCV2b ORF2; wherein the sample is removed from one of: an animal material selected from a body fluid and a tissue, a preparation of the animal material, and a vaccine preparation.