Pall ForteBio Introduces Off-the-Shelf Dip and Read Anti-CHO HCP Detection Kit to Accelerate Drug Development

Pall ForteBio, a division of Pall Corp. has announced commercial availability of a new Dip and Read Anti-CHO (Chinese hamster ovary) Host Cell Protein (HCP) Detection Kit for quantitation of residual HCPs. Kit users benefit from faster time to results, enhanced range of detection and better assay precision, all of which accelerate the drug development timeline while improving safety and efficacy. The kit can also be applied in production phases to confirm reduction or removal of HCP, increasing efficiency and speed of production.

The kit combines the Pall ForteBio Octet platform for rapid high-throughput protein analysis with the broad HCP recognition and sensitivity of the industry-standard Cygnus 3G anti-CHO HCP antibody. The high-precision assays have 5–10% CVs, and the design allows the analysis to be done, without supervision, in 65–90 minutes.

“The commonly used ELISA HCP analytical method can require up to overnight analysis and must be monitored. Our new Dip and Read high-precision assay kit, in combination with the Octet HTX system, is hands-free, and only takes around an hour to analyse 96 samples with detection sensitivity as low as 0.5 ng/mL,” said Yves Baratelli, President of Pall Life Sciences. “This translates into a dramatic advance in the user’s process, and a drastic reduction in their time and capital investment from development through to production.”

As the most commonly used mammalian hosts for industrial production of recombinant protein therapeutics, CHO cells often leave behind contaminating HCPs. The residuals can substantially decrease the efficacy of a drug product, or even cause immunogenic reactions in patients. Therefore, detection and reduction of residual HCP contaminants is critical for drug safety and qualification.

“The HCP detection kit complements the use of Octet systems for protein titer measurement and residual protein A contaminant detection in bioprocessing. So far the feedback from customers has been exceptional. More than six key customers from large biopharmaceutical companies have completed beta testing with the product,” Robert Wicke, Sr. VP for Instrumentation R&D at Pall ForteBio, said. “It is a great complement to our full detection line, all supported by Octet instruments.”