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NMPA has asked provincial drug regulatory authorities to urge MAHs and contract manufacturers to conduct comprehensive self-inspections in line with the new requirements

In one aspect, the CDR3 region of the antigen binding molecule-encoding nucleic acid sequence is changed or "evolved." Antibody Arrays and Methods of Making and Using Them The invention provides an array (e.g., biochip) comprising a plurality of polypeptides, wherein each polypeptide is immobilized to a discrete and known spot on a substrate surface to form an array of polypeptides, wherein the plurality of polypeptides comprise a sample of (i.e., a subset of), or all of, the antigen binding sites that are isolated from and/or expressed by an individual, or, complementary to antigen binding sites isolated from and/or expressed by the individual

doi: 10.1016/0887-2333(94)00187-Y

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