By a News Reporter-Staff News Editor at Life Science Weekly -- Research findings on Enzymes and Coenzymes are discussed in a new report. According to news originating from Salisbury, United Kingdom, by NewsRx correspondents, research stated, "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)."
Our news journalists obtained a quote from the research from Health Protection Agency, "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."
According to the news editors, the research concluded: "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,."
For more information on this research see: Validation of a 30-year-old process for the manufacture of L-asparaginase from Erwinia chrysanthemi. Bioprocess and Biosystems Engineering, 2013;36(4):453-60. (Springer - www.springer.com; Bioprocess and Biosystems Engineering - www.springerlink.com/content/1615-7591/)
The news correspondents report that additional information may be obtained from D. Gervais, Development and Production Department, Health Protection Agency, Microbiology Services, Porton Down, Salisbury, Wiltshire SP4 0JG, UK. Additional authors for this research include N. Allison, A. Jennings, S. Jones and T. Marks (see also Enzymes and Coenzymes).
Keywords for this news article include: Europe, Salisbury, Asparaginase, United Kingdom, Amidohydrolases, Enzymes and Coenzymes.
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