Companies in the biopharmaceutical sector are striving for reliable and scalable cell culture platforms as they increase capacity and upscale the production of viral vectors. Explore the benefits of using suspension cell lines in cell and gene therapy development and why adherent cell culture shouldn’t be left behind.
Cell and gene therapies are increasingly popular vehicles for treating rare and devastating diseases. As you work to identify the right CDMO to manufacture your AAV therapy, start early and place a major premium on previous experience. The field is young and regulatory guidance is limited: robust viral vector expertise is hard to come by and can make the difference.
Adeno-associated viruses (AAV) are small viruses that can infect humans and other primate species. AAV gene therapy is one of the most promising advances in modern medicine due to its therapeutic impact on a wide range of diseases and disorders. Understand how AAV vectors and plasmids are produced.
The optimization necessary to generate a reliable AAV platform that can support scale-up is complex. CDMOs must understand what parameters are necessary to achieve linearity from flask to bioreactor, how differing technologies and approaches influence variability, and how to balance technical considerations with manufacturability.
One of the best ways for an organization to vet a potential manufacturing partner is by evaluating that partner’s experience. While the advanced therapy field is still nascent, there are a number of CDMOs with direct experience in clinical development for viral vector vaccines, AAV gene therapies, and other related modalities.