Vaccines
Case Study on Formulating a Multidose Lyophilized Measles-Rubella (MR) Vaccine Candidate for Local Manufacturing in Africa: Lab-Scale Results and Lessons Learned for Future Technology Transfer
By Kathryn Secrist, Prashant Kumar, Michael Z. Wang and 7 others.
Abstract
Background/Objectives: Local manufacturing of Measles-Rubella (MR) vaccines is part of a multifaceted approach to improve vaccine accessibility in Africa, yet process development and technology transfer challenges remain for large-scale production of viral bulks and lyophilized drug product. This case study describes lab-scale formulation development of a multidose, lyophilized MR vaccine candidate, leveraging the availability of concentrated bulks of Measles (MeV) and Rubella (RuV) produced in MRC-5 cells by a new bulk manufacturing process.






