{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T19:49:26Z","timestamp":1790884166493,"version":"4.1.0"},"reference-count":60,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2021,10,21]],"date-time":"2021-10-21T00:00:00Z","timestamp":1634774400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Basic fibroblast growth factor (FGF-2) is a highly labile protein with strong potential for tissue engineering. The aim of this study was to develop FGF-2 formulations that are stable against physical stressors encountered in pharmaceutical processing and evaluation. Pharmaceutical excipients, alone or in combination, were added to aqueous FGF-2 (770 ng\/mL) solution and the stability of the resulting solutions on storage at 4\u201337 \u00b0C was evaluated. Stability of the solutions to repeated freeze-thaw cycles and lyophilisation was also evaluated, as well as the stability of the lyophilised stabilised protein to storage at \u22124, 4 and 18 \u00b0C for up to 12 months. In all of these experiments FGF-2 was quantified by ELISA assay. The as-received FGF-2, when dissolved in water, was highly unstable, retaining only 50% of baseline protein content after 30 min at 37 \u00b0C or 1 h at 25 \u00b0C. By contrast, FGF-2 solutions prepared with 0.5% w\/v methylcellulose (MC) and 20 mM alanine (formulation F5) or with 0.5% w\/v MC and 1 mg\/mL human serum albumin (HSA) (formulation F6) were highly stable, having residual FGF-2 content comparable to baseline levels even after 2 h at 37 \u00b0C and 5 h at 25 \u00b0C. F5 and F6 were also highly stable to repeated freeze-thaw cycles, with &gt;99% of FGF-2 load remaining after the third cycle. In addition, F5 and F6 were stable to lyophilisation, and the lyophilised products could be stored at \u22124, 4 or 18 \u00b0C for at least 12 months, with less than 1% loss in mean FGF-2 content. Thus, FGF-2 solution is effectively stabilised against both thermal and processing stressors in the presence of MC and alanine (F5), or MC and HSA (F6). The resultant FGF-2 solutions may be applied as medicinal products or further processed into more advanced medicinal products, e.g., scaffolds, for wound healing and tissue regeneration.<\/jats:p>","DOI":"10.3390\/pharmaceutics13111762","type":"journal-article","created":{"date-parts":[[2021,10,21]],"date-time":"2021-10-21T23:27:39Z","timestamp":1634858859000},"page":"1762","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Stabilisation of Recombinant Human Basic Fibroblast Growth Factor (FGF-2) against Stressors Encountered in Medicinal Product Processing and Evaluation"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2459-315X","authenticated-orcid":false,"given":"Leah R.","family":"Benington","sequence":"first","affiliation":[{"name":"Division of Pharmacy, School of Allied Health, University of Western Australia, Perth 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunesh","family":"Rajan","sequence":"additional","affiliation":[{"name":"Otolaryngology, Head & Neck Surgery, Division of Surgery, Medical School, University of Western Australia, Perth 6009, Australia"},{"name":"Department of Otolaryngology, Head & Neck Surgery, Luzerner Kantonsspital, 6000 Luzern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8773-3036","authenticated-orcid":false,"given":"Cornelia","family":"Locher","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, School of Allied Health, University of Western Australia, Perth 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7307-0742","authenticated-orcid":false,"given":"Lee Yong","family":"Lim","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, School of Allied Health, University of Western Australia, Perth 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,10,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1038\/nrd2792","article-title":"The FGF family: Biology, pathophysiology and therapy","volume":"8","author":"Beenken","year":"2009","journal-title":"Nat. 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