Document Detail

Validation of a 30-year-old process for the manufacture of L: -asparaginase from Erwinia chrysanthemi.
MedLine Citation:
PMID:  22907565     Owner:  NLM     Status:  Publisher    
A 30-year-old manufacturing process for the biologic product L: -asparaginase from the plant pathogen Erwinia chrysanthemi was rigorously qualified and validated, with a high level of agreement between validation data and the 6-year process database. L: -Asparaginase exists in its native state as a tetrameric protein and is used as a chemotherapeutic agent in the treatment regimen for Acute Lymphoblastic Leukaemia (ALL). The manufacturing process involves fermentation of the production organism, extraction and purification of the L: -asparaginase to make drug substance (DS), and finally formulation and lyophilisation to generate drug product (DP). The extensive manufacturing experience with the product was used to establish ranges for all process parameters and product quality attributes. The product and in-process intermediates were rigorously characterised, and new assays, such as size-exclusion and reversed-phase UPLC, were developed, validated, and used to analyse several pre-validation batches. Finally, three prospective process validation batches were manufactured and product quality data generated using both the existing and the new analytical methods. These data demonstrated the process to be robust, highly reproducible and consistent, and the validation was successful, contributing to the granting of an FDA product license in November, 2011.
David Gervais; Nigel Allison; Alan Jennings; Shane Jones; Trevor Marks
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-8-21
Journal Detail:
Title:  Bioprocess and biosystems engineering     Volume:  -     ISSN:  1615-7605     ISO Abbreviation:  Bioprocess Biosyst Eng     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-8-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101088505     Medline TA:  Bioprocess Biosyst Eng     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Development and Production Department, Health Protection Agency, Microbiology Services, Porton Down, Salisbury, Wiltshire, SP4 0JG, UK,
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