Automation in biopharmaceutical production: essential

The biopharmaceutical industry is shifting towards creating more specific, personalized and powerful treatments. These changes make production batches smaller and force laboratories to have a very efficient, optimized and plotted production. One way to address this operational efficiency is to implement a certain degree of automation in the process.

A very common mistake when the term “automation” comes out, is to believe that it implies automating an entire line 100%. Thinking that it means that the batch is going to be produced from the API to the packed product, with a record of all the parameters, and without the intervention of any operator. And that implementing all these changes is going to require an enormous investment difficult to amortize. There are many levels of automation, and those can be applied to all the process or only certain stages.

Depending on the integration between processes, we can broadly differentiate between:

• Automation at process unit level: 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 made up 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 again…). An automated control in which an operator terminal (HMI) is integrated allows setting parameters that will be adjusted automatically according to conditions, as well as monitoring and supervising the process in progress.
• Automation at the platform level: in this case, several units or an entire production line could be controlled from the same interface. This allows 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 operators must master to just one, and allows for standardized data collection across units, facilitating processing, and complying with FDA Title 21 CFR part 11 on electronic records. This model allows to have a very good global vision of the whole process, which is key to be able to improve 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 field.

On the other hand, just as it is never too late to introduce a certain level of automation into your process, it is also never too early to start thinking about automating. In fact, it is preferable to start assessing the automation strategy in the basic or even conceptual design. Defining the automation strategy as soon as possible helps to make adequate decisions more quickly and not involving suppliers in the project that 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 embedded systems are going to be from different vendors. A lack of definition in the early stages could end up causing incompatibilities between equipment that delay the project and make it more expensive.

The production of biopharmaceuticals involves many different steps from the manufacture 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 streamlines this process. In addition, 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 the production team. It is essential to have an objective in mind and draw up a plan in the short, medium and long term that allows the design to have the necessary versatility to progressively adapt the plant or line to changes. For example, if I want to automate the data collection of a chromatography, but at the same time I am aware that in 3 years I want to increase production and I will need more purification capacity (meaning I will need more chromatography columns), I will take this into account from the beginning. When I make the changes in the room to digitize the column I already have, I will also make the necessary changes to have all the necessary infrastructure the day I include more columns in my facility. This way the change will take less time and I will save resources.

The benefits of process automation cannot be ignored and will end up making it essential in the biopharmaceutical industry. Staying behind is not an option. Adapting to this new reality is practically mandatory for anyone who wants to have a future in this sector.

If you are interested in learning more about automation, digitization and how we can help you, contact us: klinea@klinea.es