What are the developments that set the trend for pharmaceutical filling and packaging machines? Gerhard Breu, Chairman, Optima Pharma Division, provides answers and explains what strategies he plans to use to face the current market requirements. An additional focus in the machine industry is digitalisation and its effects on the processes. Optima is becoming a major provider of solutions and technologies for turnkey projects
You started in July 2017 as an authorised representative for Optima Pharma. What are your responsibilities?
My responsibilities include the strategic development and implementation for Optima Pharma, as well as, the development and intensification of the collaboration between different locations. Therefore, we have a better understanding of the general context. The main benefit for our customers is that we can offer product portfolios that are adjusted to the entire process chain. It is also important to me that we strengthen the support for our customers worldwide – not only the deliveries, but also the local service for machines. We have reached our objective when the customer perceives it.
‘The life cycle management will play a larger role’
What are the developments that shape the current market for pharmaceutical filling and packaging lines?
Currently, we see a trend for more biotechnology products and individual therapies for patients. The variety of products increases drastically and many of them are very potent. Therefore, our machines have to be highly flexible to process these products, containers and batch sizes.
It has to be recognised that the life cycle of products will be much more dynamic and new product varieties and containers have to be processed. This calls for more flexible and reconfigurable solutions that will enable the life cycle management. We will definitely consider this during the conceptual design in order to meet customer requirements.
How does Optima Pharma react to this development?
I will give you two specific examples. The trend towards flexibility is solved with the utilisation of robots.
We are also developing a process solution for the isolator and freeze-drying field at the Metall+Plastic location in Radolfzell and at Optima Pharma in Mornshausen that will reduce the current cycle times.
Are there other trends?
We have a wide range of customers from small start-up companies to manufacturers of biosimiliars. Optima customers also include those that are highly specialised contract fillers to large pharmaceutical companies.
A keyword – Contract Filler – A start-up company describes Optima Pharma as the only vendor, worldwide, that is capable of supplying a machine that has the required flexibility. Is this correct?
We are happy to hear that. We, at Optima, believe that we are the market leader with our MultiUse system. This is not only a solution for contract fillers, but also for those needing to process small batch sizes, require quick format changes and filling with minimum product loss in different containers. These are all of interest for many of our customers.
‘We see ourselves as an agile, platform based, customiser’
What are the implications on the Optima Pharma process for the new market requirements?
Our processes adjust systematically to the new requirements. We see ourselves as an agile, platform-based customiser. I would even go as far as to say that customer-specific solutions are in our DNA. We will show our processes, in detail, at this year’s Achema show and we will present solutions under the motto ‘Smart Solutions for Pharma Experts.’
I am also impressed with the status of Optima Pharma’s digital engineering. Now is the time to apply it to projects to benefit our customers. This includes virtual reality technology for process simulations or virtual installations.
We also see ourselves as a system provider that is capable of delivering complete lines with a completely integrated FAT to ensure a fast and safe production start.
Personalised medicine is getting more important and it is believed that the growth potential is increasing even more. How does Optima see that?
At Optima, we are building upon our existing knowledge. In the past one-and-a-half years, we have developed an extensive knowledge and understanding of the personalised medicine market. Due to our experts, we are able to react to the needs and requirements of the market. We are in close contact with our customers and are working together with them to develop market solutions to meet the demands of the market.
Does this mean you are interested in cultivating additional development partnerships?
Definitely, close collaboration benefits both sides. Together, we will be able to create optimum process safety and productivity.
Are there markets you want to address more in the future?
Additionally, we will engage more in markets outside of Europe and North America. All product groups are equally important to us. In the future, we will not only be a mere machine vendor for certain applications but will focus more on processes and solutions for selected product groups and therapies. This is similar to a paradigm shift. We believe we mastered the machine technology pretty well. The next step will be to select the correct technologies and processes for new medical therapies. We are moving more into the position of a provider of integrated solutions than just a simple machine manufacturer.
Does this mean you will focus more on larger companies in the future?
Not at all. I am happy that Optima is working more and more with smaller companies. This proves that we also have the correct solutions for small, specialised companies.
What are the areas in which Optima is well positioned and where do you see development potential?
Our increasing order volumes shows that we are on the right track. Team work is well pronounced at Optima Pharma; nevertheless, we are still striving to improve our collaborations with agile approaches. In addition, we will expand our production capacities at the location in Schwäbisch Hall. It is very important to satisfy new market requirements and to achieve faster installations. Our technology centre will also be further developed in order to benefit our customers with process related procedures.
What distinguishes Optima Pharma from the competition?
We are the technology partner for companies working in new therapy fields. I believe we already have the complete machine range for this cliental. We are the best-suited system provider offering fill and finish, isolator and lyophilisation technologies and solutions to meet complex challenges. Therefore, I call us an agile, platform-based, customiser that understand small batch processes as well as large-scale production.
How does digitalisation influence the filling processes of pharmaceutical products?
Two big concerns of the pharmaceutical industry are ‘data integrity’ and ‘cyber security.’ Data integrity means the collection of data without redundant entries, to prohibit data manipulation and ensure data safety.
Another key item is the smart operator guidance. We support this with our TCAM system. Future machines will guide the operator and not vice versa. This will benefit pharma companies that do not have experienced personnel.
Shorter production cycles require the efficient planning of maintenance tasks that have to be executed more quickly. We also support the customer with our smart services that are combined under the lifecycle management system ‘Optima Total Care.’
Another very important subject is data analytics. Here the question arises; how can we derive data from production samples? This data informs us how the quality of the product has changed or will change and how much high quality final product the machine produced. That is especially important for small batch sizes where the focus is to minimise product loss as much as possible. These solutions are ideal for biotechnology products since they are such a rare commodity and product yield is of utmost importance. We are on the right track at Optima Pharma to make progress in the market together with our customers.
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