Development of a process for upscaling and production of thermotolerant Peste-des-petits ruminants vaccine
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ORIGINAL ARTICLE
Development of a process for upscaling and production of thermotolerant Peste-des-petits ruminants vaccine Mousumi Bora1 • Chhabi Lal Patel1 • Kaushal Kishor Rajak1 • Med Ram Verma2 Raja Wasim Yousuf1 • Rabindra Prasad Singh1
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Received: 10 April 2020 / Accepted: 26 May 2020 Indian Virological Society 2020
Abstract Vaccination is the most effective means of preventing Peste-des-petits-ruminants (PPR), an important disease of small ruminant population. The thermolabile nature of PPR vaccine poses a major constraint in shipping, storage and its successful application. In view of limited thermotolerance of PPR virus and ongoing global PPR control and eradication program, development of a thermotolerant PPR vaccine was tried using a novel lyophilization protocol and improved thermostabilization. A lyophilization cycle of 16 h (h) using 200 ll of PPR vaccine virus (stock titre 5.8 log10 TCID50/vial in 200 ll) was developed. For this, five stabilizer formulations were selected out of ten formulations based on the stability of liquid vaccine at 37 C and three freeze–thaw cycles. Improved thermostabilization of PPR vaccines was obtained by inclusion of 5% trehalose and 0.5% gelatine to Lactalbumin hydrolysate-sucrose (LS) formulations which significantly improved the stability of lyophilized vaccines with a shelf-life of at least 1305.3 days at 2–8 C, 23.68 days at 25 C, 20.88 days at 37 C, 5.01 days at 40 C and 3.22 days at 45 C which qualifies the standards of a thermotolerant PPR vaccine as defined by the FAO and OIE. In reconstituted vaccines, the combination of LS, trehalose and gelatin (LSTG) provided a shelf-life of 1.77 days at 37 C, 22.41 h at 40 C and 10.05 h at 45 C.
& Rabindra Prasad Singh [email protected] 1
Division of Biological Products, ICAR-Indian Veterinary Research Institute, Izatnagar, Bareilly, Uttar Pradesh 243 122, India
2
Division of Livestock Economics, Statistics and Information Technology, ICAR-Indian Veterinary Research Institute, Izatnagar, Uttar Pradesh 243122, India
The study suggested that use of the short lyophilization protocol standardized with 200 ll of lyophilized PPR vaccine stabilized with LSTG formulation, can be used to develop and upscale thermotolerant PPR vaccines during national and global PPR control and eradication as targeted by the FAO and OIE by 2030. Keywords Peste-des-petits ruminants Vaccine Lyophilization Upscaling Thermostability
Introduction Peste-des-petits ruminants (PPR), affects about 80% of the global small ruminant population causing morbidity, mortality and significant economic impact to livestock economy affecting livelihood security of developing nations [9]. As per recent statistics of the World Organization for Animal Health (OIE) and the Food and Agricultural Organization (FAO) of the United Nations, the current expenditure on PPR vaccination have been estimated to be between US$ 270 and US$ 380 million per year [9]. Due to its devastating effects on the global food security and economic growth, the O
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