Purity Considerations For Use Of Antibodies As Pharmaceuticals

Although purities of 95% or greater are often suitable for antibodies intended for nonpharmacological use, such as in vitro diagnostic reagents, much greater levels of purity are required for those intended for use as pharmaceuticals. In general, there are three types of contaminants of concern to regulatory agencies: microbes, viruses, and their products, such as endotoxins, proteins, and DNA (1,2). These contaminants must be removed to trace levels.

The need for sterility of a biological product intended for use in humans is a given. This is primarily assured by strict adherence to both aseptic technique and cGMP (100). Less apparent is the need for a validated process to remove any potential viruses that may be present in the crude material, including murine retroviruses, which are present in almost all hybridoma cell lines. These issues have been addressed in some detail by the regulatory authorities (1,2,83,101,102).

These regulatory authorities, such as the Center for Bi-ologics Evaluation and Research division of the FDA, have relied on a three-tiered approach to controlling any infectious agents that may be present in the crude product or acquired during the downstream processing.

1. Careful selection of raw materials, including media components, for the absence of biological contaminants

2. Validating that the purification process can remove or inactivate viruses

3. Full testing of the product at appropriate stages in the process for the presence of viruses and infectious agents

Each of these three tiers of control must be adhered to by those engaged in the purification of antibodies for human use. A full treatment of these regulatory considerations is beyond the scope of this article. The reader is encouraged to refer to the cited references and keep abreast of current regulations issued by the various governmental agencies.

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