|
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 an effort to provide these tools as aid to the
biopharmaceutical industry after 2 years of in-house
product development. These kits are manufactured by us
using contaminants which are generic in nature.
“KRIBIOLISA”
is the bioprocess contamination
products range from KRISHGEN
BIOSYSTEMS. These are ELISAs 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.
Our Validation Protocols followed are indicated
separately. For individual kit
validation details, please view the kit insert or
ask us for further details.
All our kits now carry the Gold
Quality Ring with 5 stars as a mark of our Quality
Assurance. An assurance from us on the quality
of our kits and the vigorous validation and QC
protocols they follow before they are released for
sale.
|
