Home WebinarsEmpowering Global Health: The Journey to GMP-Ready mRNA Manufacturing

Empowering Global Health: The Journey to GMP-Ready mRNA Manufacturing

WEBINAR

Join us for a webinar on the WHO/MPP-led mRNA Technology Transfer Programme, highlighting the GMP-ready filtration process for the AfriVac 2121 vaccine. We'll discuss the challenges and collaborative efforts in mRNA purification, and how these advancements promote global health equity and pandemic preparedness.

This webinar intends to share the development of a GMP-ready filtration production process under the WHO/MPP mRNA Technology Transfer Programme, focusing on the development of the AfriVac 2121 vaccine candidate in collaboration with Afrigen Biologics, the Center of Excellence in this Programme.

Key technical insights will be presented, including the optimization of tangential flow filtration (TFF) processes, which transitioned from R&D scale to 100 mL and then to 1 L IVT (in-vitro transcription) scale. Trials demonstrated the effectiveness of TFF filters with 300 kDa regenerated cellulose membranes, enhancing product recovery while maintaining mRNA integrity, with robust scaling outcomes.

Additionally, the importance of bioburden control filtration will be discussed, emphasizing the use of Milligard^® PES and Millipore Express^®SHC filters, which consistently achieved over 95% recovery while preserving mRNA integrity.

These advancements not only facilitate GMP-readiness for mRNA vaccines and therapeutics but also contribute to global health equity by establishing sustainable production capabilities in Low- and Middle-Income Countries (LMICs), positioning us better for future pandemic preparedness.

In this webinar, you will learn about:

the key purification challenges in mRNA manufacturing met in the programme.
the collaborative efforts between Merck and Afrigen in developing GMP-ready purification processes, with optimization and robust scale-up implementation.

Speakers

Tanja Smith, Ph.D.

Afrigen

Principal Investigator

Tanja Smith, Ph.D. is the principal investigator at Afrigen Biologics. She has a background in molecular biology and vaccine development, having joined the purification team at Afrigen (mRNA Center of Excellence for the WHO/MPP mRNA Technology Transfer Programme) in 2022 as an R&D Scientist, with a focus on developing the TFF units of operation. Dr. Smith holds a Master’s in Human Molecular Biology from the University of the Free State and a Ph.D. in production animal studies from the University of Pretoria, South Africa.

Shajahan Cheriya

Merck

Senior Biomanufacturing Engineer

Shajahan is a senior biomanufacturing engineer with more than 14 years of experience in bioprocess engineering and biopharmaceutical production. He supports process development, scale-up, and troubleshooting across upstream, downstream, and fill-finish operations. His expertise spans single-use and multi-use technologies, with specialization in filtration (TFF, sterile filtration, chromatography), equipment commissioning and qualification (bioreactors, fermenters), and technology transfer for biologics and vaccines. He holds a master’s degree in biochemistry and a diploma in bioprocess engineering.

Josephine Cheng

Merck

Senior Modality Leader RNA Therapeutics

Josephine leads RNA therapeutics initiatives across the APeC region, where she fosters customer collaborations, drives innovation, and transforms scientific insights into sustainable go-to-market strategies. With more than 16 years of experience spanning lab management, technology management (chromatography and TFF), customer training, segment market development (plasma, vaccine, mRNA), strategy consultation, and customer applications for novel modalities, Josephine has successfully led cross-functional programs and international partnerships. She is also an active contributor to thought leadership and scientific publications. Josephine holds a Master’s degree in Bio-resources and Agriculture from National Taiwan University, specializing in protein and molecular science.