The manufacture of biopharmaceuticals can be complex due to the fact that they are produced within living cells (bacterial, yeast, plant, eukaryotic cells). Process-related impurities encompass those that are derived from the cell substrates (e.g. host cell proteins, host cell DNA). Processes must be tightly controlled to ensure a consistent product that meets the submitted specifications of the biomolecule.

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

It essential to monitor  for presence of residual Host Cell Proteins (HCP) in biopharmaceuticals for patient safety, failure to remove or reduce them to safe levels has led to rejection by regulatory agencies.  RSSL 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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