Host Cell Proteins Contamination Kits

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.

HCPs 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 us. These are ELISAs in 96 well format with convenience of break-apart strips.

Key Features
• 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 on a separate page. For individual kit validation details, please view the kit insert or ask us for further details. >>know more

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.

Cat No	Product Particulars	Insert	MSDS	Pack Size	Price USD
KBBP01	E-coli HCP ELISA			96 wells	500.00
KBBP02	Pichia Pastoris HCP ELISA			96 wells	500.00
KBBP03	CHO HCP ELISA			96 wells	500.00
KBBP04	Protein A ELISA			96 wells	400.00
KBBP05	SP 2/0 HCP ELISA ***			96 wells	500.00
KBBP06	Ovalbumin ELISA ***			96 wells	400.00
KBBP07	HSA ELISA			96 wells	300.00
KBBP08	IgG ELISA			96 wells	300.00
KBBP09	IgA ELISA			96 wells	300.00
KBBP10	Bovine Serum Albumin ELISA			96 wells	400.00

*** coming soon

Bioassays Kits

We offer kits for complete biological testing as per IP / BP / USP. From application development and technical system support to complex biological assays, we offer complete solutions. Biological assays are a need for compliance of monographs for IP / BP / USP. With our eight years of experience in biotechnology, we have the capabilities to provide you or support you with custom made solutions. For example, a majority of LMW Heparin / Enoxaparin Sodium manufacturers or formulators use our assay kits for their regular QC.

We provide assays for hormones, enzymes, cell-based assays for cancer drugs amongst others. With our offices in US and Europe we have the capabilities to develop the assays in-house or source them from companies worldwide. Our current product portfolio includes assays for -
 

*** coming soon

Immunogenicity Kits

Immunogenicity of Protein Therapeutics

Immunogenicity can have a number of effects on the therapeutic outcome of a biologic; for instance, reduce the efficacy of a biologic by lowering the molecule’s half-life in the circulatory system because of rapid clearance by immune cells or may even lead to generation of auto-antibodies to the patient’s natural version of that protein. Our assays can be used for the following purposes:

• Characterize isotyping and subtyping of antibodies involved in the immunogenic response.

• Generation of data for specific isotyping and subtyping of antibodies involved in the immunogenic response.

• Study of immunogenic portion of the protein therapeutic

• To establish baseline or pretherapy immune response.
  Post-launch surveillance of patient population to identify patients who may generate neutralizing antibodies

Cat No	Product Particulars	Insert	MSDS	Pack Size
KBI001	Human IgG quantitation ELISA			96 wells
KBI002	Human IgG Isotyping Kit (IgG1. IgG2, IgG3, IgG4)			96 wells
KBI003	Mouse IgG quantitation ELISA			96 wells
KBI004	Mouse Isotyping ELISA			96 wells
KBI005	Rat IgG quantitation ELISA			96 wells
KBI006	Bovine IgG quantitation ELISA			96 wells