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During the manufacturing process, biopharmaceuticals have the potential to be contaminated with process-related impurities such as host cell proteins, cell culture medium components, chromatography and other reagents.

Additionally, proteins such as bovine serum albumin and human serum albumin may be purposefully added to a final product as a product stabilizer. As a result, biopharmaceuticals often contain protein contaminants or protein additives. Insufficient removal of these contaminants compromises product quality and safety and has significant cost implications. The quantitation of protein, whether impurities or stabilizers, in manufacturing intermediates and final products demonstrates process control and reproducibility. The Food and Drug Administration (FDA) suggests that potential product contaminants or additives be quantified in purified bulk. Final containers from each filling of product should be tested for preservatives and excipients, when appropriate, to assure a quality product. Similar to the FDA, the International Conference on Harmonisation (ICH) guidelines suggest that appropriate systems be in place to ensure that process-related impurities do not compromise product safety and quality. Biologic therapeutics manufacturers (down-stream processing), DNA vaccine manufacturers and clients requiring a biologic activity endpoint/lot release test would require immunoassay tests to be carried out.

Immunoassay services include:

• Vaccinia plaque and plaque reduction neutralization assays
• Residual host cell protein/residual culture or processing reagent ELISA
• Scrapie Western Blot
• DNA transfection and protein detection (ELISA and Western Blot)
• Thrombin inhibition
• TF-1 cell proliferation assays (Alamar Blue)
• MTT-based cell proliferation assays

BioReliance offers the detection and measurement of host cell proteins and manufacturing process proteins by immunoassay.