Viral vectors are vehicles for delivery of therapeutic DNA in cell and gene therapies. With over 1,000 cell and gene therapy (CGT) clinical trials underway globally, there is a growing need to address challenges in viral vector manufacturing – both upstream and downstream. In a previous post, we outlined the key steps in downstream processing (DSP) for the manufacturing of lentiviral vectors (LVV). Achieving high concentration without aggregation is a significant technical bottleneck in manufacturing LVV. In this post, we will explore the concept of viral aggregation and its influence in every step of DSP for LVV.Read More
Viral Aggregation in Downstream Processing of Lentiviral Vectors
What is a Bioreactor and How is it Used in Cell and Gene Therapy?
Simply put, a bioreactor is a stand-alone cell culture vessel enabled with sensors. Bioreactors differ fundamentally from traditional R&D cell culture in their ability to monitor and control key parameters such as temperature, pH, and dissolved oxygen (DO). Continuous, in situ monitoring of these parameters allow for a deep understanding of the growth environment of a given cell population -- creating avenues for process improvement. Paired controls enable dynamic, real-time responses as cells grow and the culture changes over time. With these capabilities, bioreactors can overcome limitations of traditional cell culture enabling the use of cell culture for commercial or clinical purposes.Read More
What Is the Best Way to Manufacture Lentiviral Vectors for Cell and Gene Therapies?
In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and Lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by its end use. AAVs are most commonly used to deliver gene therapies – meaning they will be administered directly to a patient. In contrast, LV is typically used as an input material to genetically modify cells used for cell therapies (e.g. CAR-Ts) and is not included in the final product delivered to the patient.Read More