Monitoring biopharmaceutical waste streams: a needs and systems analysis of laboratory analytical technologies

The demand for more and better biopharmaceuticals continues to grow both in the U.S. and abroad. The production of biopharmaceuticals often involves the manipulation of genetically engineered microorganisms (typically those of a pathogenic nature) from production through harvest, sterilization, and ultimate discharge of the waste into the environment. The prospects of accidental and unintentional release of pathogenic genetically engineered microorganisms have increased the interest in assessing the potential risk to human health. There is an unfulfilled need to provide an assessment of the health risk posed by the release of biopharmaceutical wastes.

Environmental sampling and analysis may provide the data necessary to support an assessment of the health risk due to the release of biopharmaceutical wastes. An important element of an environmental sampling and analysis capability is laboratory analysis. A need, to evaluate and recommend laboratory analysis technologies, was identified. In response to the need, user needs and requirements were developed. Via systems analysis, candidate laboratory analysis technologies were identified and evaluated for suitability in meeting user needs and requirements. A laboratory analysis technology configuration was delineated. Finally, methods were proposed to guide other organizations in modifying and applying the evaluation process.

Major findings are:

• No one, single laboratory analysis technology is able to satisfy the high-level requirement to monitor biopharmaceutical waste streams for microorganisms, nucleic acids, proteins, and toxins;

• The leading laboratory analysis technologies for monitoring biopharmaceutical waste streams are immunological, hybridization, and biosensor; and

• Immunological, hybridization, fermentation, and staining/microscopy technologies comprise the laboratory analysis technology configuration.