Pharmacokinetic assay and immunogenicity assay are important efficacy and safety assays in IND filing and clinical trials. Anti-idiotype antibodies are the main raw material for PK and ADA assays. Therefore, as a critical reagent, the quality of anti-idiotype antibodies can have a significant impact on the efficacy and accuracy of subsequent Pharmacokinetic assay and immunogenicity assay. Especially in long-term clinical trials, it is critical to ensure the consistency of the kits from batch to batch. So, a strict critical reagent management strategy is needed to ensure the batch-to-batch consistency of the assay kits and thus the reliability of the results.
As a result, by developing PK kit and ADA kit, you can maintain the consistency of every assay. GenScript ProBio provides a one stop solution from anti-ID Abs discovery to PK kit and ADA kit development. You can choose either to manufacture kits with us or we can transfer the protocol to you or your specified DMPK vender.
We are compliant in data management by having well-established operating procedures and management systems to regulate the recording and review requirements of data generated during the PK kit and ADA kit production process; regular calibration and verification of data-generating measuring instruments to ensure data reliability; back-upped original data in accordance with data management requirements.
Beyond that, we are compliant in records management for complete paper-based operating procedure documents and experimental record forms; a complete quality management system for documents and records, including processes for approval and review of documents and records, printing and issuance, record requirements, filing and preservation, copying and destruction, etc.; complete electronic record management system, including regular inspection of computerized system, time and time zone management, backup of system data, operation authority and user authority management, etc.
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