Claudia Roth, PhD
President, Vetter Development Service USA
What is driving the trend toward single-use systems in clinical manufacturing?
Drug companies are facing ever-increasing cost and time pressures in the early development field. For example, they are
looking for opportunities that best optimize critical processes in clinical manufacturing, including methods to achieve shorter
turnaround times of drug products. Another challenge is the need to have scalable processes and batch sizes during these phases,
while ensuring investments such as filling equipment stay within reasonable limits. Being in the development stage of the
drug substances also demands flexibility; one needs to be able to react quickly to changes that happen at short notice.
Why are single-use systems an advantage in clinical manufacturing?
Single-use systems provide an intelligent response to many challenges. For example, these systems allow for greater efficiency
because they are already well proven and can make available commercial manufacturing know-how for smaller batches, which is
a part of early development. Modern single-use solutions are also particularly oriented toward reducing loss of active drug
substance. By deploying single-use systems, the efforts of a cleaning validation can be avoided, saving time and money in
addition to enabling lead-time optimization. Also, single-use systems offer advantages in terms of quality and safety and
are a lot easier for employees to use. Overall, they offer smoother processes and, therefore, contribute to optimizing costs
and reducing time-to-market.
When are single-use systems worth deploying?
Single-use systems are a benefit in many areas including weighing excipients and drug substances, preparing materials,
compounding, and even filtration and filling. As an example, single-use mixers have proven their value in compounding, and
disposable connectors and filling needles have proven their value in filling.
What does a company have to be careful of?
It is critical that when adopting a single-use strategy, a comprehensive supplier and quality management system is put
into place. This includes confirmed matching of specifications and reliable quality control. For example, in our development
facility in Chicago, where we have implemented all the appropriate processes, we have had very good experiences with single-use
systems in clinical manufacturing.