Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare-the Case for Surrogate Matrices.

Autor: Dubiel EA; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Myler H; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA. Heather.Myler@ppd.com., Arnold ME; Labcorp Drug Development, 8211 SciCor Drive, Indianapolis, Indiana, 46214, USA., Bennett P; Alliance Pharma Inc., 17 Lee Blvd., Malvern, Pennsylvania, 19355, USA., Gatz J; BioIVT LLC, PO Box 770, Hicksville, New York, 11802, USA., Groeber E; Charles River Laboratories, 1407 George Rd, Ashland, Ohio, 44805, USA., Gupta S; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Kane C; KCAS Bioanalytical and Biomarker Services, 12400 Shawnee Mission Parkway, Shawnee, Kansas, 66216, USA., Li F; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Mylott W; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Noah C; BioIVT LLC, PO Box 770, Hicksville, New York, 11802, USA., O'Dell M; Labcorp Drug Development, 8211 SciCor Drive, Indianapolis, Indiana, 46214, USA., Tewalt E; PPD Clinical Research Services, Thermo Fisher Scientific, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA., Warrino D; KCAS Bioanalytical and Biomarker Services, 12400 Shawnee Mission Parkway, Shawnee, Kansas, 66216, USA., Vick A; Charles River Laboratories, 1407 George Rd, Ashland, Ohio, 44805, USA.
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2022 Mar 14; Vol. 24 (2), pp. 42. Date of Electronic Publication: 2022 Mar 14.
DOI: 10.1208/s12248-022-00694-1
Abstrakt: The COVID-19 pandemic has strained the biological matrix supply chain. An upsurge in demand driven by numerous COVID-19 therapeutic and vaccine development programs to combat the pandemic, along with logistical challenges sourcing and transporting matrix, has led to increased lead times for multiple matrices. Biological matrix shortages can potentially cause significant delays in drug development programs across the pharmaceutical and biotechnology industry. Given the current circumstances, discussion is warranted around what will likely be increased use of surrogate matrices in support of pharmacokinetic (PK), immunogenicity, and biomarker assays for regulatory filings. Regulatory authorities permit the use of surrogate matrix in bioanalytical methods in instances where matrix is rare or difficult to obtain, as long as the surrogate is appropriately selected and scientifically justified. Herein, the scientific justification and possible regulatory implications of employing surrogate matrix in PK, immunogenicity, and biomarker assays are discussed. In addition, the unique challenges that cell and gene therapy (C>) and other innovative therapeutic modalities place on matrix supply chains are outlined. Matrix suppliers and contract research organizations (CROs) are actively implementing mitigation strategies to alleviate the current strain on the matrix supply chain and better prepare the industry for any future unexpected strains. To maintain ethical standards, these mitigation strategies include projecting matrix needs with suppliers at least 6 months in advance and writing or updating study protocols to allow for additional matrix draws from study subjects and/or re-purposing of subject matrix from one drug development program to another.
(© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.)
Databáze: MEDLINE
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