In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection solutions can help.
Karen Langhauser: Last year, more than 5 million people in the U.S. were written prescriptions for weight loss injectables, a 2082% increase from 2019. To date, over 655 million mRNA COVID vaccine doses have been administered in the U.S. alone. It is estimated that last year, over 33,000 U.S. patients were treated with cutting-edge approved cell or gene therapy.
To patients, these three statistics might not seem related, but behind the scenes, these products have one very big thing in common: They all require syringes, cartridges or vials, all of which need to be carefully inspected to ensure quality — and that is no easy feat.
I'm Karen Langhauser, chief content director for Pharma Manufacturing magazine, and you're listening to a special solution spotlight edition of Off Script, a Pharma manufacturing podcast. Joining me today to talk about how new automatic inspection solutions are answering current market needs, is Veronica Ghidotti, product manager of visual inspection systems at Stevanato Group. Welcome, Veronica.
Veronica Ghidotti: Ciao, Karen, nice to meet you, and nice to meet you to everybody that is listening to us right now.
Karen Langhauser: So, it's been a busy few years for the pharma industry. How have pharma markets shifted?
Veronica Ghidotti: We encountered basically two major shifts. One, related to the increased request for drugs for obesity and weight loss. On the other side, for sure, the COVID pandemic has led to an high-volume drugs that had to be quickly inspected. When I watched the near future, I would say that also the trend of biologic drugs will quickly lead the market.
Karen Langhauser: That's a lot of changes in a short amount of time. What has this meant for the pharma industry in terms of packaging and inspection?
Veronica Ghidotti: Well, if we linger on the packaging, we can see that with the increase of chronic disease, such as diabetes, and the general attention to the patient quality of life, the market for the at home self-administration drugs is rising. As immediate effect, it led to the syringes and cartridges becoming a popular choice for autoinjector and pen injector devices watching at the COVID-19 vaccine that during the pandemic required really high volume batches requesting the use of vials. Now, that the pandemic has turned into an epidemic, this is leading to an increase of the use of the pre-filled syringes for the vaccine sub administration. Focusing on the inspection, the growth of biologics, biotech, and also gene therapies and mRNA that are typically a value product made in small batches, we saw that the implementation of flexible production strategy that could provide control of the many variables that could have impact on the processes. It's very, very important. On the other end, vaccine production and blockbuster drugs are always on the market and distributed in higher quantity. This means very large batch sizes that are requiring to be inspected at very high speed, but without compromising the quality.
Karen Langhauser: So with these new and shifting demands, how can automating inspection help the pharma industry meet these demands?
Veronica Ghidotti: Well, today and watching what happened in the past year, the use of the automation really accelerate. If we think about the pandemic years, the pharma companies experienced really labor shortages with disruptive impact on the supply chains. This kind of exposure and challenges led many companies to accelerate all the programs for the adoption of the technology. Basically, introducing the automated and robotic processes, it's possible to ensure performances that are equal or superior to the ones provided by the human operator with the great improvement of the reliability and the repeatability. This could grant the stability of the product quality. So, there are really a lot of positive effect that could be reached with automation.
Karen Langhauser: Sure. So, Stevanato Group is a leader in this space. Are there specific offerings from Stevanato that are tailored towards these different types of trending drug products?
Veronica Ghidotti: Yes, absolutely. Thanks a lot for the question. At Stevanato Group, our goal is to provide the ideal solution accordingly to the specific customer needs because our approach is absolutely to put our customer at the center. Thinking about the drug trend that we just saw, I would say that thinking about obesity drugs, GLP-1, insulin and all those categories of product, our CVT core platform can be considered the best in class choice because this solution fits for companies that needs to inspect difficult drug challenging product such as suspension, [inaudible] drugs, formula, liquids, or also lyophilized product. The challenge is also to doing that at very high speed. When I say very high speed, I mean 600, 800 pieces per minute. The solution is really convenient whenever the eye throughput is required, ensuring always the best in class inspection performances.
Dealing with mRNA monoclonal antibodies proteins, I would say that MAVIS Combi can be considered as the most appropriate choice because is a very flexible solution that allows the inspection of, first of all, different type of containers. This means that with one unique machine, it is possible to inspect from the vials up to the syringes, passing through cartridges and ampules, always ensuring the high quality inspection system and considering also the capability to manage product also in different type of presentation from the bulk to the nest tub.
Lastly, we spoke about cell and gene. We spoke about therapies with high quality, high value, and made in small batches. I think that the value that is our robotic system is the right solution because it's an autonomous island that doesn't require any human intervention. So, it's also suitable for dangerous product because it's not exposing the operator and always as our standard providing top inspection both cosmetic and particles. I would say that we are ready to face all the challenges of the new product.
Karen Langhauser: Yeah, certainly. It seems like you have a lot of solutions for the industry right now. In terms of inspection solutions, how can digitalization help the pharma industry of the future?
Veronica Ghidotti: Well, digitalization is very popular, is a major trend. There are many companies that are approaching the digitalization right now. Some others are really hired in the journey. What I would say is that the digitalization can really lead to ensure higher quality of the product, help improving performances and time savings. At Stevanato Group, we witness firsthand how the artificial intelligence can impact in cost saving. We use it both in our internal glass manufacturing, but we are also sharing this experience with our customers in the solution that we are providing. For example, our SG Vision AI is an artificial intelligence platform that helps delivering, enhanced the inspection performances, increasing the detection rate, and at the same time minimizing the false rigid rate.
There is also our inspection digital twin. That is a really powerful instrument that is basically a digital replica of the inspection software that we have installed on our inspection machine and allows you to process product images, optimize inspection performances, and speed up the validation time always without stopping the production. Basically, digitalization is crucial for the pharma for dot zero. We are anyway working on a new product and new solution. The data collection is an important topic, not only the connection, but also the collection and the connection, of the data is really important to create a new level of transparency, enabling faster decision making, and providing in line and in time control over business operation and quality.
Karen Langhauser: That's really interesting stuff. It's fantastic. I think that's all the questions we have. Thank you for joining us today, Veronica, and we appreciate your time and your insight.
Veronica Ghidotti: Thanks to you.
Karen Langhauser: You've been listening to a Special Solutions Spotlight episode of Off Script. Thanks so much for joining us. If you're enjoying Off Script, please help us by rating and reviewing the podcast in your favorite podcasting app. We look forward to joining us again in our next episode.
