As biopharmaceuticals are produced within living cells (bacterial, yeast, plant or eukaryotic cells), impurities may arise during the manufacturing process that are derived from the production system (e.g. host cell proteins, host cell DNA).

Analysis is essential to detect the host cell DNA that could be a risk to patients, due to potential oncogenicity, infectivity and immunomodulatory effects. RSSL scientists are experts in the accurate and sensitive quantitation of host cell DNA impurities whether encountered at the drug discovery stage or in production.

It is also essential to monitor for presence of residual Host Cell Proteins (HCP) in biopharmaceuticals to safeguard patient safety; failure to remove or reduce them to safe levels may cause your product to be rejected by regulatory agencies. 

Our experts are able to perform both generic HCP assays and validated product-specific HCP assays after proper assay transfer to RSSL.


Techniques

Enzyme-Linked Immunosorbent Assay (ELISA)

Western-Blotting

2-D PAGE

Real-Time Polymerase Chain Reaction (RT-PCR)

High through put host cell DNA analyses with the MagMAX™ Sample Preparation System

Spectrophotometric DNA quantification with PicoGreen® dsDNA quantitation assay

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