title: Quality control of a medicinal larval (Lucilia sericata) debridement device based on released gelatinase activity.
abstract: Lucilia sericata Meigen (Diptera: Calliphoridae) larvae are manufactured worldwide for the treatment of chronic wounds. Published research has confirmed that the primary clinical effect of the product, debridement (the degradation of non-viable wound tissue), is accomplished by a range of enzymes released by larvae during feeding. The quality assessment of larval activity is currently achieved during production using meat-based assays, which monitor insect growth and/or the reduction in substrate mass. To support this, the present authors developed a complementary radial diffusion enzymatic assay to produce a visual and measureable indication of the activity of larval alimentary products (LAP) collected under standardized conditions, against a gelatin substrate. Using basic laboratory equipment and reagents, the assay is rapid and suited to high throughput. Assay reproducibility is high (standard deviation: 0.06-0.27; coefficient of variation: 0.75-4.31%) and the LAP collection procedure does not adversely affect larval survival (mortality: < 2%). Because it is both cost- and time-effective, this method is suited to both academic and industrial use and supports good manufacturing and laboratory practice as a quality control assay.
authors.affiliation: Division of Regenerative Medicine and Cellular Therapies, School of Pharmacy, University of Nottingham, Nottingham, U.K.
authors.forename: S F
authors.identifier: 0000-0001-5617-9992
authors.initials: SF
authors.lastname: Pickles
authors.affiliation: Division of Regenerative Medicine and Cellular Therapies, School of Pharmacy, University of Nottingham, Nottingham, U.K.
authors.forename: D I
authors.initials: DI
authors.lastname: Pritchard
mesh_terms: D000818:Animals; D003646:Debridement / Q000379:methods*; D004175:Diptera / Q000201:enzymology / Q000254:growth & development / Q000502:physiology*; D005247:Feeding Behavior; D018093:Gelatinases / Q000032:analysis*; D019476:Insect Proteins / Q000032:analysis*; D007814:Larva / Q000201:enzymology / Q000254:growth & development / Q000502:physiology; D011786:Quality Control; D015203:Reproducibility of Results
chemical_list: D019476:Insect Proteins; D018093:Gelatinases
keywords: Lucilia sericata; debridement; gelatinase; medical device; quality control; wound management