Achema Pulse: Fast Track Vaccine Achieving More with Modularization and Digitalization
An insightful discussion on accelerating project completion times and reducing costs in the pharmaceutical industry was held at the recently conducted virtual Achema Pulse show. Other interesting topics such as digitally enhanced management processes were also discussed at the session.
Industry experts comprising André Overmeyer, SVP – Head of Supply Chain – Electronics – Display Solutions, Merck Group; Heinrich Meintrup, Senior Vice President – Head of BU Pharma & Healthcare, GEA; and Michel Claes, Portfolio Manager, Siemens; set the stage for the panel discussion.
Helena Carmen Felixberger (Moderator of the discussion): What are the key aspects for speeding up project execution?
Heinrich Meintrup, Senior Vice President – Head of BU Pharma & Healthcare, GEA: From a supplier point of view, it's worthwhile to look at our fastest projects and also understand the reason behind it. Our fastest executed projects are with customers that we know. There is a trust between the parties and you know what you can expect from the other party. Also, certain technologies may be repeated in a project as they have been selected by the client before. This leads to better speed. Hence, the key ingredient is to put every nose in the same direction so that we can aim for speed, this is our main goal.
André Overmeyer, SVP – Head of Supply Chain – Electronics – Display Solutions, Merck Group: The Covid pandemic is a very unusual situation and has its own challenges. The speed that we need in this scenario, can only be achieved by using existing facilities as well as equipment that already exist. Only with this, can we upscale production within months which normally in our pharmaceutical world, and as an excipient and API manufacturer, takes years.
For instance, in a pandemic, one has to prioritize a certain product because of its demand. If you prioritize a product like lipids you will have to make the production of other products flexible which means that you can either outsource them or divert the production to other plants. So, now you are focusing only on lipids, that's how we gain speed. However, this cannot be done always.
Felixberger: How can standardization and modularization speed up project execution?
Meintrup: Whatever you can repeat is more safe and also quick in execution. The general rule is that if you execute something for the second, third or the fourth time, it is automatically faster and also cheap. In our case, we have broken down key processes or key applications into units, operations and steps. We look at the modules and then give alternatives (building blocks), where you can still comply with special requirements, and then focus on the rest that is not covered by these modules instead of discussing every single course from scratch.
In a pandemic, one has to prioritize a certain product because of its demand. If you prioritize a product like lipids you will have to make the production of other products flexible. This is how we gain speed.
Also, it can be a two-fold approach, a customer can ask for a repeat order. In this case, it’s just repeating something that has already been executed before on a special and specific customer design. Hence, it can be executed faster but one has to really look at what can be reinvented in this whole chain and where's the value in it compared to what does it mean to be in terms of time and delivery speed.
Michel Claes, Portfolio Manager, Siemens: Modularization can be carried out on a parallel track but if you add standardization to it, it becomes very interesting. For a while now, we do not have single use equipment for biopharma but infact we have units that are very standardized. These are off the shelf, reengineered, and they have their own local intelligence which have already been validated. If you take these pre-validated components and reuse them in your project, you save time not only on engineering but also on validation efforts. This is a big step.
Overmeyer: Modularization and standardization are best practices and we have been doing it since many years. However, you still have to follow the principles of the GMP validation where you want to exclude risks for patients and that requires smarter approaches. For example, one needs to be precise on what one wants to include in their EQ and PPQ runs, etc. This will save a lot of time especially when switching products from one plant to another or upscaling procedures, and so on.
Modularization and standardization are best practices and we have been doing it since many years. However, you still have to follow the principles of the GMP validation.
Felixberger: What would you consider to be the most time-consuming part?
Meintrup: From an equipment supplier side, we have developed fast track equipment which takes about 8-14 months to develop. We can squeeze this time by days or weeks but the real leeway is how many additions of testing procedure have to be done. We have seen cases where the same test procedure has been run three or even four times to checkmark all the requirements of the documentation. In a risk-based approach you try to put things on a parallel track and avoid duplications. An intelligent documentation testing procedure is the biggest aspect for speeding up projects.
Felixberger: Covid-19 and the lockdowns have changed the manner in which colleagues interact and work. Are there any learnings from this situation in terms of project execution?
Claes: Yes, we have held remote meetings before the Covid situation wherein we could connect with anyone in the world and carry out testing for different projects.
Meintrup: For us it was a huge learning curve. At the beginning of the corona crisis, we experienced some major project delays due to travel restrictions as we have experts that are based in Europe and we have to bring them on site. Our company has developed a digital tool box which we have been successful in executing. For example, we had to execute a project in Japan and it was done remotely. From this, we have learned that we can leverage expertise and bring together many more important stakeholders from the benefit of a customer. We can gain speed from this but only on the basis that we ‘know’ the customer. The obstacle in this situation is trust. Both the parties have to have the same interest.
Overmeyer: We have a global production network and this means that all the digital tools were already established before the pandemic as it was always needed. Now, we have transitioned to a more or less 100 % remote working situation but in this case the social glue is missing.
Meintrup: There are somethings that we cannot substitute. In an online setting, you do not have people around and this is an element which should not be underestimated. In the long run, it has to be a combination of both.