G01N2333/30

Identification of mycoplasm contamination using Raman spectroscopy
09856505 · 2018-01-02 · ·

A manufacturing method comprises collecting a sample from a cell culture used by a manufacturing application, and controlling a Raman spectrometer to collect a Raman spectrum of a targeted volume within the sample. The method further comprises obtaining reference spectra uniquely associated with a known cell line, which comprise at least two of: spectral measurements of mycoplasma by itself, a contaminated cell line, and a pure cell line. Moreover, the method comprises comparing the reference spectra to the collected spectrum, and identifying whether there is at least one unnatural molecular composition within the collected spectrum based upon the comparison of the reference spectra to the collected spectrum. An indication is provided as to whether mycoplasma is detected in the collected Raman spectrum where at least one unnatural molecular composition is identified within the collected spectrum, and the manufacturing application is stopped where mycoplasma is detected in the collected Raman spectrum.

POTENCY TEST FOR VACCINE FORMULATIONS

The invention relates to certain methods for the determination of an antigen content of a first antigen in a mixture comprising two or more antigens. The invention also relates to a potency test for an antigen in a combination vaccine. The method allows the determination of the antigen content in a mixture additionally comprising antibodies that are capable of binding with the antigen.

Potency test for vaccine formulations

The invention relates to certain methods for the determination of an antigen content of a first antigen in a mixture comprising two or more antigens. The invention also relates to a potency test for an antigen in a combination vaccine. The method allows the determination of the antigen content in a mixture additionally comprising antibodies that are capable of binding with the antigen.

METHODS AND COMPOSITIONS FOR DETECTING AND TREATING MYCOPLASMA PNEUMONIAE
20260139038 · 2026-05-21 ·

Provided are monoclonal antibodies and antigen-binding fragments that specifically bind the CARDS toxin or the P1 adhesin of Mycoplasma pneumoniae. The antibodies enable rapid, sensitive detection of M. pneumoniae infection and provide therapeutic neutralization of toxin activity or inhibition of bacterial adherence. Also provided are nucleic acids, vectors, host cells, pharmaceutical compositions, diagnostic methods, and kits using these antibodies.