Chemical and Heat Treatment for Viral Inactivation in Porcine-Derived Gelatin

• Published in: BMC biotechnology 2024-12, Vol.24 (1), p.99-99, Article 99
• Main Authors: Kadji, Francois Marie Ngako, Shimizu, Maiko, Kotani, Kazuki, Kishimoto, Masanori, Hiraoka, Yosuke
• Format: Article
• Language: English
• Subjects: Adenoviridae; Animal products; Animals; biocompatible materials; Biomaterials; Biomedical materials; Carnivore protoparvovirus 1; Cattle; Chemical properties; Chemical treatment; Contaminants; Cytotoxicity; Deactivation; drugs; Ethanol; Ethanol - chemistry; Ethanol - pharmacology; Gelatin; Gelatin - chemistry; Gelatin - pharmacology; Good Manufacturing Practice; Heat treating; Heat treatment; Heat treatments; Heating; Hot Temperature; Inactivation; Inoculation; Manufacturing; Manufacturing industry; Medical devices; Medical equipment; medicine; Methods; Parainfluenza; Parvoviruses; Patient safety; Pharmaceutical research; Pigskins; Product testing; Production processes; Raw materials; Regenerative medicine; Reoviridae; Suid alphaherpesvirus 1; Swine; Temperature; Tissue engineering; viral contamination; Virus inactivation; Virus Inactivation - drug effects; Viruses; Viruses - drug effects; Viruses - isolation & purification
• ISSN: 1472-6750; 1472-6750
• DOI: 10.1186/s12896-024-00922-w

It is mandatory to demonstrate the removal or inactivation of potential viral contaminants in the manufacturing processes of pharmaceuticals derived from biomaterials. Porcine-derived gelatin is used in various medical fields, including regenerative medicine, tissue engineering, and medical devices. However, the steps of virus inactivation in the gelatin manufacturing process are poorly defined. In this study we evaluated virus inactivation in two steps of the gelatin manufacturing process. Pig skin (4.5 g), including solid pieces as intermediate products, was spiked with model viruses, including CPV (canine parvovirus), BAV (bovine adenovirus), BPIV3 (bovine parainfluenza type 3), PRV (pseudorabies virus), BReoV3 (bovine reovirus type 3), and PPV (porcine parvovirus), and underwent chemical treatment with alkaline ethanol or heat treatment at 62 °C followed by inoculation in relevant cell cultures. Viral titers in the samples were calculated based on the Behrens-Kärber method. Model viruses were inactivated at different rates; however, effective inactivation of all model viruses was demonstrated by an LRV (log reduction value) over 4 by both chemical and heat treatment, and chemical treatment demonstrated rapid inactivation compared to heat treatment. The chemical and heat treatment steps exhibited meaningful viral inactivation capacity. They are integrated parts in the extraction and manufacturing process of porcine-derived gelatin, ensuring virus safety for use in medical applications.