In vitro transcribed (IVT) mRNA is gaining momentum as a potential new drug class for induction of antigen-specific immunity especially in the field of immuno-oncology, but also as a starting material in cell therapy approaches for gene editing or immune therapy purposes.
Cutting-edge technologies took time to mature but meanwhile direct injection of RNA for immunization has been shown to be sufficiently improved. Improvements in methods for mRNA synthesis and stabilization have yielded promising results in preclinical studies over the past years. Consequently, mRNA-based cancer immunotherapies (in vivo and ex vivo applications) and infectious disease vaccines have entered clinical development.
Emerging novel approaches include in vivo delivery of IVT mRNA for protein replacement, the generation of pluripotent stem cells and genome engineering using IVT mRNA-encoded designer nucleases.
BioNTech IMFS can provide you with GMP quality in vitro transcribed mRNA that can be used either as a drug product for in vivo use or as an API/starting material for ex vivo applications. Our state-of-the-art scalable GMP manufacturing process is based on technologies developed at our mother company BioNTech AG, the world leader in RNA based drug development and yields up to grams of high quality mRNA.
A comprehensive QC and QA program ensures a robust manufacturing process and an exceptional and consistent batch-to-batch quality as well as compliance with regulatory requirements. To support your product development in the most efficient way, we at BioNTech IMFS do not only focus on quality, scalability and speed but also on costs. Since 2011, BioNTech IMFS has produced more than 80 batches of clinical grade IVT mRNA.
Dr. Andrea Schilz
Tel +49 (0) 6781 98550