Lonza agreed to a collaboration that will integrate Agilent’s current and new analytics technologies and techniques into the Lonza Cocoon® platform’s cell therapy manufacturing workflow to explore current and assess new Critical Quality Attributes (CQAs) required for the release of the therapeutic to the patient.
By integrating Agilent analytical technologies both at-line and in-line within the Cocoon platform automated manufacturing workflows, manufacturers will be able to ensure that in-process controls and analytics can be employed on demand to deliver a more consistent drug product, according to Nicholas Ostrout, senior director, business strategy & implementation, personalized medicine, Lonza.
Product quality and consistency are significant challenges for cell therapy manufacturing due to the complexity of the products and patient-specific variability. In addition, cell therapy products are largely defined by the process, which means minor changes during manufacturing could potentially cause major changes in the quality and efficacy.
In-process controls and analytics
In-process controls and analytics are critically important in ensuring a consistent drug product even in the presence of such variability to provide real-time information on CQAs throughout the manufacturing process and for quality control release testing.
By understanding the CQAs required for a potent and persistent cell therapy product, the manufacturing process can be “directed” in real-time. This is especially critical in autologous cell therapies due to the high variability of patient starting material.
“The collaboration with Agilent is extremely complementary to our long-term goals for the Cocoon platform and we are very excited about this synergistic relationship” says Ostrout. “There is a huge opportunity through this partnership to determine what the ideal critical quality attributes are for manufacturing the most effective cell therapy, and drive the manufacturing, optimally in real-time, to meet those criteria.”
“This timely combination is well positioned to deliver the first fit-for-purpose solution for scaled manufacturing of autologous cell therapies,” adds David Ferrick, VP of new market development, Agilent’s cell analysis division.
The Cocoon Platform is an automated and closed platform for patient-scale cell therapy manufacturing, designed to overcome manufacturing challenges associated with patient-scale precision medicines.