The trend in the biopharmaceutical industry is to create increasingly specific, personalized and powerful treatments. These changes make production batches increasingly smaller and force laboratories to have very efficient, optimized and traced production. One of the ways to address this operational efficiency is to implement automation in the process.
A very common mistake when the term “automation” comes up is to believe that it implies automating an entire line 100%. Thinking that it means that the batch will be produced only from the API to the packaged product, with a record of all the parameters, and without the intervention of any operator. And implementing all these changes will involve an investment of astronomical figures that will be difficult to amortize. There are many levels of automation and it can be applied only to certain stages of the process.
Depending on the integration in processes, we can differentiate, broadly speaking, between:
· Automation at the level of process units: an interface that allows the control of a specific unit (for example: a bioreactor). This unit may or may not be part of a line composed of more units forming a system. It is even difficult to imagine controlling, for example, a cell culture manually (I take a sample, I need to raise the pH, I add base, now the optical density is low, I increase agitation, the cell population increases, I have a pH too low…). An automated control in which an operator terminal (HMI) is integrated allows setting parameters that will be automatically adjusted according to the conditions, as well as monitoring and supervising the running process.
· Automation at the platform level: in this case several units or an entire production line could be controlled from the same interface. This makes it possible to greatly simplify the management of the control of the line or system: instead of having several control systems with different mechanisms, there will be only one type; It simplifies the number of interfaces that operators have to master to a single one, and allows standardized data collection between the different units, which facilitates its processing and complies with Title 21 CFR part 11 on FDA electronic records. This model allows you to have a very good global vision of the entire process, which is key to improving the efficiency and productivity of the line.
The possibilities of automation in the pharmaceutical industry are much broader than these two cases, which are applied to a very specific area.
On the other hand, just as it is never too late to introduce some level of automation into your process, it is also never too early to start thinking about automating. In fact, it is preferable to start evaluating the automation strategy in the basic or even conceptual design. Defining the automation strategy as soon as possible helps to make appropriate decisions more quickly and not to involve in the project suppliers who cannot comply with the strategy outlined from the beginning.
“Define your goals now to avoid problems later”
It is also important to establish the level of integration between the different production systems. Especially if the integrated systems are going to be from different vendors. A lack of definition in early phases can end up causing incompatibilities between teams that delay and increase the project’s cost.
The production of biopharmaceuticals involves many different steps from the manufacturing and purification of the API, to the final packaging of the drug. All these units will generate data that is necessary to release the batch. Automating the collection and analysis of this data improves efficiency and speeds up this process. Furthermore, combining this technology with others such as single-use equipment allows the plant to be versatile to produce different products very efficiently and optimize spaces.
Automating and digitizing is a progressive process that requires time, resources and the adaptation of production equipment. It is key to have an objective in mind and draw up a short, medium and long-term plan that allows the design to have the necessary versatility to progressively adapt the plant or line to the changes. For example, if I want to automate chromatography data collection, but at the same time I am aware that in 3 years I want to increase production and will need more purification capacity (that is, put in more chromatography columns), I will take this into account from the beginning. principle. When I make the changes in the room to digitize the column I already have, I will also make the necessary changes so that the day I need to include more columns I already have all the necessary infrastructure. This way the change will take much less time and I will save resources.
If you are interested in learning more about automation, digitalization and how we can help you, contact us: klinea@klinea.es
