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Biopharmaceutical products from
recombinant DNA can be contaminated with components of
the host cell system used to manufacture the drug. Even
after multiple purification steps, significant levels of
those impurities can be present. Although low levels of
most contaminants may be inconsequential, patient safety
importance requires that they be eliminated or reduced
to the lowest levels to avoid problems such as adverse
immune reactions. Impurities can have significant cost
implications in drug development and manufacture.
Failure to identify and remove these impurities early in
drug development may lead to reduced drug efficacy or
adverse patient reactions that could delay release or
kill a promising drug candidate. Reducing contaminates
to very low levels necessitates multiple purification
steps that reduce product yield.
Recombinant pharmaceutical products can be contaminated
by residual host cell proteins (HCPs) or other carry
over contaminants. It is essential part of manufacturing
of biopharmaceuticals to monitor these contaminants.
Host cell proteins produced by the host
cell during cell culturing or fermentation can cause an
immune response in patients. Their composition is
extremely heterogeneous and dependent on the protein
product and down-stream purification procedure used. The
level of contaminating host cell proteins in the
biopharmaceutical product must be quantitatively
measured.
“KRIBIOLISA” is the bioprocess contamination products
range from KRISHGEN BIOSYSTEMS, India. These are generic
ELISA in 96 well format with convenience of break-apart
strips.
Key Features
• Indian Manufactured – priced competitively; available
with shorter lead times & good product support.
• ELISA with 8 x 12 break-apart strips
• Simple procedural steps for running the Assay.
• Results available within 3 hours hands-on time.
Products :
E-coli HCP ELISA
Pichia Pastoris HCP ELISA
CHO HCP ELISA
HSA ELISA
Protein A ELISA
SP 2/0 HCP ELISA ***
Ovalbumin ELISA ***
IgG ELISA
IgA ELISA
Bovine Serum Albumin ELISA ***
*** coming soon
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Host Cell Proteins in
CHO Cells
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