As the benefits of single-use became clear and the technology became established in the 2000s, there was a drive to utilize it in more process steps. Single-use was being utilized in steps where process data would normally form part of the batch record, but as these assemblies had no automation or data capture capabilities, this information was either missing or manually recorded.
These process steps - including clarification, tangential flow filtration (TFF) and virus filtration - required complex monitoring and control as well as data acquisition. Only by automating the equipment could these systems operate, protect the process and collect and store the data in a way that was cGMP compliant.
There are a number of reasons. But perhaps it has more to do with perception than reality.
In a survey conducted during a Parker webinar entitled Single-Use Technologies, What is Next? the audience was asked: What would restrict you from implementing automation in your single-use process?
Nearly 20 percent of respondents said that their process didn't require automation.
However, it can be argued that all processes could benefit from some form of automation. It can enhance safety, improve process efficiency and release operators from some time-consuming, manual tasks, enabling them to carry out more value-added activities.
Just over 15 percent of respondents were concerned about the accuracy of sensors.
There are, however, highly accurate sensors available. For instance, Parker Bioscience Filtration's SciLog® SciPres single-use in-line pressure sensors achieve sensor accuracy of +/- 0.02 bar.
Almost 50 percent of respondents said they were concerned about cost.
Of course, there is a cost associated with putting an automated system in place, but this can also be regarded as an investment. The benefits relating to time-saving, complexity reduction, improved process security and predictability, and standardized training can all add up to a rapid return on investment for biopharmaceutical manufacturers.
As detailed above, many of the perceived hurdles to implementing automation can be overcome.
A number of key drivers in the biopharmaceutical industry can be addressed by implementing automation in single-use processes.
If the same technology on the same automation platform has been used during the development process as will be used at production scale, the scale-up will be easier to complete and more predictable when compared to a process that uses multiple automation platforms.
In addition, technical transfers can be made easier through single-use automation because a number of variables from the process can be eliminated through operators having access to the same equipment utilizing the same control systems. If consistent product contact materials are also used, extractables and leachables data are simplified, all of which again helps to increase speed to market.
Plus, an automated single-use system can be ordered, shipped and validated far more quickly than its stainless steel equivalent. The impact on timeframes is clear.
It might take five years to build and validate a stainless steel based multi-use (CIP/SIP) facility. However, it may only take two years for the equivalent single-use facility, so biopharmaceutical manufacturers can benefit from up to three years' worth of extra clinical data before pushing the button on what would be a multi-million dollar investment.
Single-use technology has clear advantages in a multi-product facility. For instance, operators will not need to validate CIP/SIP cycles or maintain costly utilities.
However, automation also allows operators to run multiple recipe-driven processes even when they have limited experience of the process being run.
For example, all TFF processes follow a certain high-level routine, but products will have differences in the recipe being executed. Being able to call up and run an automated process helps to eliminate any process errors.
The more automated a process is, the more repeatable that unit operation should be. This helps biopharmaceutical manufacturers comply more easily with regulations, as it reduces process variation. Automation also enables training to be simplified and will reduce the potential for process deviations caused by manual operations and indeed, human error, which can impact on productivity and operator safety.
In addition, an automated system allows for the creation of a batch record along with the compliant storage of data and the audit trail for the data set, again helping biopharmaceutical manufacturers to meet regulatory requirements more easily - and allowing far less room for error.
With biosimilars coming online, more focus is being placed on the cost of goods sold (COGS). Through automation, the number of people involved in a unit operation can be decreased and the supply chain around the process can be simplified. In effect, you can do more with less.
Single-use systems are a key enabling technology for continuous processing. To allow continuous processing in single-use processes, the automation of valves, feedback from sensors and control logic will need to be in place. An automated approach, therefore, is essential for a single-use continuous process to work.
Single-use system implementation and single-use automation should be viewed jointly - and as shown above, automation can take the advantage gained from single-use to a much higher level.
Read the full white paper - Automation in Single-Use: Unlocking the True Potential of Single-Use Technology
This post was contributed by Guy Matthews, division marketing manager at Parker Bioscience Filtration, United Kingdom.
Parker Bioscience Filtration specializes in automating and controlling single-use bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively, ensuring the quality of the final product.