Automation of the clinical trials process? Is that possible?
In this post you will learn more about the clinical trial process. But also, why a Graniten customer choose to streamline their process of clinical trials with automation.
introduction to clinical trial:
Clinical trials play a pivotal role in the pharmaceutical industry, serving as rigorous scientific investigations to assess the safety, effectiveness and the potential side effects of new drugs or treatments. These meticulously planned and controlled studies involve human participants, following strict protocols and ethical guidelines.
Through clinical trials, researchers gather essential data that informs the development, optimization, and regulatory approval of innovative medical interventions.
By evaluating the real-world impact of pharmaceutical interventions, clinical trials contribute to advancing medical knowledge and improving patient care. Today the process is mainly handled by humans. Soon, it can be fully automized to meet up the demand on personalized medicine!
Interview WITH a GRANITEN CUSTOMER
Kevin Braeckmans, Pharma process Engineer at Graniten, interviewed a customer about why they choose to harness automation within their clinical trial process.
THE PAIN POINTS OF CLINICAL TRIALS
What is special about producing clinical trial batches, and what are the main challenges for the pharma manufacturer?
The main challenge is the small batch sizes that clinical trials require, needing a lot of changeover time. Besides, there is a vast variety of different sizes to be handled. The products are also serialized with an identity number, so the placebo’s can be differentiated from the active product by the researchers.
Clinical trial labels are also more challenging than usual. They must contain detailed information in the native language about application and can contain small booklets.
Is late-stage customization important in clinical trials?
Yes, because clinical trial production is usually kept as bright stock, which is then labelled for a specific study just before shipping it. Expiry dates also tend to change, when new stability studies results are in throughout the research phases. In this case the products are potentially re-labelled and inspected.
Do you see evolutions in clinical trial production?
Portfolio is shifting from tablets, and solids to large molecules (fluids in vials, syringes, and autoinjectors), and cold chain.
FROM MANUAL CLINICAL TRIAL TO AN AUTOMATED PROCESS
When would you work manual, and when would you see automation as a solution in clinical trials?
The clinical trial work is mostly handled manually. The cleaning or clearing of machinery can take more time than the potential benefit that it delivers. In addition, format changes increase this time, when a different recipe is selected. With our current processes, and traditional automation equipment, you would need a batch size of several thousands before it becomes efficient. Only in processes where automation can add a quality benefit, traditional automation is introduced quicker.
But then why did you choose a Graniten Flexline solution for producing clinical trial batches?
It is flexible, and is designed for handling small batch sizes, where set-up time is usually longer than the actual run time. Since the Flexline is fast in technical changeovers, because no format parts are required, we can gain a lot of efficiency by using it. We could also change it to another configuration, if our portfolio changes.
CONCLUSIONS WITH KEVIN
So, in conclusion, the journey towards enhanced clinical trials begins with the adoption of automation.
-“By streamlining processes and reducing manual errors, automation not only saves time and resources but also enhances the accuracy and reliability of the trial data.
As the landscape of clinical trials continues to evolve, embracing automation is essential for organizations to stay ahead” says Kevin Braeckmans.
fully automated PACKAGING MACHINES FOR CLINICAL TRIALS AND, RESEARCH AND DEVELOPMENT DEPARTMENTS
The Graniten Flexline packaging platform, is designed to handle high mix, low volume production. It can handle many different formats of bottles, vials, syringes and autoinjectors with close to zero changeover time. And thanks to the modular concept of the platform, it is possible to alter the machine for future needs and get a true sustainable solution.