Today, Eurocine Vaccines AB (“Eurocine Vaccines”) announces the completion of knowledge transfer and preparations for the development of the manufacturing process to secure the active protein needed in the toxicological and clinical studies with the company´s chlamydia vaccine candidate and start of process development activities.
“It is extremely satisfying to see the rapid and precise work with transferring our know-how in this development project. Biovian, our selected CDMO, has proven their scientific and technical ability in this area of biologic process development and GMP manufacturing”, says Sandra Jeldes Granstrand, Director of CMC Development, Eurocine Vaccines.
“We have reached an important milestone by generating the research cell bank for the work to come. Now, the extensive work with developing a quality assured manufacturing process and thorough documentation has begun. My team and I are thrilled to work at the frontier of advanced drug development with the experts of Eurocine Vaccines”, says Soile Tuomela, Project Manager at Biovian.
The process development activities now initiated according to schedule, are planned to result in pilot scale batches necessary for the toxicological and clinical studies later in the project. As previously described, early development of a fully industrial manufacturing method significantly reduces risks in connection with future up-scaling and commercialisation. Such a method is, in addition to strong patent protection, an extremely valuable asset in discussions with partner candidates about out-licensing.
Definitions:
CDMO – Contract Development and Manufacturing Organisation
GMP – Good Manufacturing Practice
Research cell bank – the cell line designed to produce the active protein during the process development phase of the project
About the market potential for a chlamydia vaccine
Chlamydia is a sexually transmitted bacterial disease where preventive vaccines are lacking on the market today. The global sales potential for a successful chlamydia vaccine is considered to be comparable to the sales of HPV vaccines, Gardasil and Cervarix. Together, these vaccines sold for more than $ 2.5 billion in 2017 and are expected to reach $ 5 billion by 2024, according to Globe Life Sciences Ltd. (London, UK), a company specializing in market analysis.
About the need for a chlamydia vaccine
Chlamydia infection is the most common type of sexually transmitted infection and the majority of sexually transmitted chlamydia shows no symptoms. It is estimated that 130 million cases of chlamydia infection occur globally each year. The infection can, especially in women, lead to severe complications, such as infertility, ectopic pregnancy, and premature birth. In addition, chlamydia infection can lead to increased susceptibility to other sexually transmitted diseases. Therefore, there is a strong need for preventive vaccines against chlamydia, a need that has also been identified by the WHO. Despite that, there are only two products against chlamydia in clinical phase, one of which is a preventive vaccine candidate.
Furthermore, effective vaccines and vaccination programs against bacterial infections are one of the best ways to counteract the development of antibiotic resistance, a serious threat to global health.