05.09.23 -- Controlling Raw Material Variability

All of biopharma, including drug substance manufacturers and suppliers, need to address and meet the requirements of the industry regarding raw material quality and consistency.

Important ways for you to guarantee a steady supply of materials and technologies include qualifying two suppliers, increasing capacity, implementing a scorecard methodology for strategic suppliers, and surveying suppliers for their number of production lines. And you must pay close attention to raw materials.

Cytiva can manufacture media containing metal and other trace impurity concentrations within the limits you define. To do this, we use a combination of innovative raw material analysis, data analytics, and a proprietary algorithm to select raw material lots. To date, we have successfully manufactured numerous lots using this technique.

Cytiva performed an assessment of the physical, chemical, and biological characteristics of representative complex media and feeds to compare pin mills and overall dry powdered medium manufacturing processes.

To address the many challenges in manufacturing cell and gene therapies, you need to build an adequate supply chain with the necessary equipment and protocols.