Harmonized Or Standardized Bio-assay Quality Control Material

Harmonized or Standardized Bioassay Quality Control Material

Solomon Park Research Laboratories, Inc., prides itself on delivering the highest-quality harmonized bioassay quality control materials to the biotechnical industry.

Using our trademarked SPRL-RefKits™ and AccuBase-CQM™ services, we can produce control materials that are harmonized and standardized. This ensures that your laboratory instruments are correctly calibrated and deliver the right patient test results, assisting medical specialists treat patient conditions successfully.

A bioassay is an analytical method designed to determine the strength and concentration of an agent by observing its effect on living cells. Bioassays are biological assays used to evaluate the agent’s potency by examining their impact on cell culture systems in vitro.

A biological assay can also be described as a biological testing device used to estimate the biological activity of a biochemical in a formulated product. A bioassay test also provides detailed information on the biological activity of a compound. Bioassay systems and their role in the biostatistical analysis have increased in importance in efficiently controlling the quality of biopharmaceutical development and manufacturing.

Because of the bio-pharmaceutical industry’s diversity, there is a need for standardized bioassay quality control materials. Solomon Park manufactures these materials as industry-standard benchmarking or quality control tools. We do not produce bioassays or analytes. We develop the materials as the control mechanism to test the bioassay’s success.

At Solomon Park Research Labs, we have the facilities and instruments to run clinical chemistry analysis tests for CROs (Contract Research Organizations) and pharmaceutical companies.

CROs provide outsourced research services to support the pharmaceutical, biotechnology, and medical device industries. Some of these services include biopharmaceutical development, biological assay development, preclinical research, clinical research, and pharmacovigilance.

Our clinical chemistry analyzers run assays on test samples like blood serum, plasma, and urine to detect the presence of analytes that indicate drugs or disease for the CRO’s specific research study. Common elements of these analytes or bioassays include specific metabolites, electrolytes, drugs, and proteins. And the results from these tests provide feedback on toxicology and renal, cardiac, and liver function; thereby, providing answers to the questions that the research study has asked.

Contact Solomon Park now to discuss how we can develop standardized controls for your analyte or bioassay, or how we can help your research study by running assay tests on our clinical chemical analyzers.

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