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Pall launches off-the-shelf Dip and Read Anti-CHO HCP detection kit to accelerate drug development
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Port Washington, New York
October 29 , 2014
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Pall ForteBio LLC, a division of Pall Corp. and a leading supplier of
instrumentation and analytics for accelerated drug discovery and
development, 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 to 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 analyze 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.”
The Dip and Read HCP Detection Kit is globally available as a catalogue item along with the Octet product line.
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