Advanced therapy medicinal products (ATMPs) is a new field collectively encompassing gene therapy, somatic cell therapy, and tissue-engineered medicines offering innovative therapies and improving patient care. The recent advancement of encapsulated delivery mechanisms within the gene therapy space, most notably adeno-associated viruses (AAV) and lentivirus delivery systems, have enabled the potential treatment of once incurable diseases and improving patient lives. However, gene therapy product purification present several unique challenges including:
- Concentration of Product – viral vectors are often present in low concentrations in the cell culture supernatant
- Product Integrity – Some cell and gene therapies are sensitive to changes in temperature, pH, or shear forces
- Contaminants – Contaminants, including residual culture media components and host cell proteins, must be effectively removed
- Limited Yields and Product Loss – Many cell and gene therapies involve low-yield processes
- Scale-Up and Commercial Manufacturing – Scaling-up production may lead to challenges in maintaining product quality and yield
- Cost – Many purification steps can be time-consuming and resource-intensive
- Quality Control – Monitoring product purity and batch-to-batch consistency, especially in large-scale manufacturing
- Regulatory Compliance – Ensuring consistent and reliable purification processes that are compliant with regulatory standards
These challenges can be addressed through innovative purification technologies, process optimization, and adherence to strict quality and safety standards. Verdot offers a combination of single-use and stainless technologies to support the challenges associated with the downstream purification solutions for gene therapy and viral vector bioprocessing applications.
Ready to take your innovation to market?
Reach out to us to learn more about our downstream solutions for gene therapy.