BRIEFING
〈1030〉 Biological Assay Chapters—Overview and Glossary. This proposal is based on the version of the chapter official as of December 1, 2013. The Statistics Expert Committee proposes to update and expand the scope of the current chapter by changing the title to “An Introduction to the Biological Assay Chapters—Overview and Glossary” and adding the following new sections:
Introduction to Biological Assays
Some Important Characteristics of Bioassays
Life Cycle Concepts and Framework for the Bioassay Chapters
Categories and Levels of Variability Throughout the Bioassay Life Cycle
Brief Description of the Bioassay Chapters
Bioassay Glossary
This major revision will assist bioassay professionals in starting with the more technical chapters Design and Development of Biological Assays 〈1032〉, Biological Assay Validation 〈1033〉, and Analysis of Biological Assays 〈1034〉.
INTRODUCTION TO BIOLOGICAL ASSAYS
Biological assays, or bioassays, are indispensable to the pharmaceutical and biologics industry, since they play an essential role throughout all stages from discovery to manufacturing of drug substances and drug products. During the research phase, bioassays are developed to help design a biological by matching its structure with its function as defined by the target mechanism of action. During development, bioassays are used to support clinical trials as well as process and formulation development. In the process of manufacturing, bioassays are used to help ensure reliable and high-quality drug products and drug substances. This chapter aims to describe bioassays for biotherapeutics, vaccines, and cell and gene therapies.
Historically, a bioassay has been defined as a measurement method capable of quantifying a response from living matter (e.g., cells, tissues, animals) that is treated with some stimulus (e.g., therapeutic preparation, prophylactic preparation, or toxin). This response, which can be continuous, discrete, or binary in nature, should be the direct effect of (known or unknown) relevant elements or constituents of the stimulus under investigation (specificity), and it should not be affected by other irrelevant elements (selectivity). The outcome of the bioassay is a biological activity or potency, often obtained by comparing the sample under study with a standard.
There are other measurement methods for biologicals that do not satisfy this strict definition of bioassays (e.g., immunoassays, polymerase chain reaction assays, enzyme-reaction assays), but these measurement methods are based on the same design and analysis principles as bioassays. A major difference between bioassays and these other measurement methods is that these measurement methods collect a response from nonliving biological material (e.g., complementary DNA, antibody-coated plates). The commonality between all these measurement methods is that they quantify potency. Thus, bioassays and these other measurement methods form a larger set of measurement methods that is typically referred to as potency assays or tests (see International Council of Harmonization (ICH) Guideline (Q6B). Although the four bioassay chapters (Introduction to Biological Assay Chapters—Overview and Glossary〈1030〉, Design and Development of Biological Assays 〈1032〉, Biological Assay Validation 〈1033〉, and Analysis of Biological Assays 〈1034〉) have been developed for bioassays alone, the chapters may typically apply to this larger set of potency tests because potency tests use the same statistical approaches to process the observed responses in assessing similarity, (relative) potency, and validity of the method. For purposes of these chapters, both types of methods will be referred to as bioassays.
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