Compositions and methods for detecting and quantifying host cell protein in cell lines and recombinant polypeptide products

A monoclonal antibody that binds hamster phospholipase B-like 2, wherein the antibody comprises:

• a variable heavy chain region comprising CDRH1 comprising the amino acid sequence of SEQ ID NO.:
• 5, CDRH2 comprising the amino acid sequence of SEQ ID NO.:
• 6, and CDRH3 comprising the amino acid sequence of SEQ ID NO.:
• 7;
• and
• a variable light chain region comprising CDRL1 comprising the amino acid sequence of SEQ ID NO.:
• 10, CDRL2 comprising the amino acid sequence of SEQ ID NO.:
• 11, and CDRL3 comprising the amino acid sequence of SEQ ID NO.:
• 12.

An immunoassay kit for the detection of hamster phospholipase B-like 2 protein comprising a capture antibody and a detection antibody, wherein:

• the capture antibody comprises a variable heavy chain region comprising CDRH1 comprising the amino acid sequence of SEQ ID NO.:
• 15, CDRH2 comprising the amino acid sequence of SEQ ID NO.:
• 16, and CDRH3 comprising the amino acid sequence of SEQ ID NO.:
• 17 and a variable light chain region comprising CDRL1 comprising the amino acid sequence of SEQ ID NO.:
• 20, CDRL2 comprising the amino acid sequence of SEQ ID NO.:
• 21, and CDRL3 comprising the amino acid sequence of SEQ ID NO.:
• 22;
• and
• the detection antibody comprises a variable heavy chain region comprising CDRH1 comprising the amino acid sequence of SEQ ID NO.:
• 5, CDRH2 comprising the amino acid sequence of SEQ ID NO.:
• 6, and CDRH3 comprising the amino acid sequence of SEQ ID NO.:
• 7 and a variable light chain region comprising CDRL1 comprising the amino acid sequence of SEQ ID NO.:
• 10, CDRL2 comprising the amino acid sequence of SEQ ID NO.:
• 11, and CDRL3 comprising the amino acid sequence of SEQ ID NO.:
• 12.