Pharma Web Conference More Speed Please! How the Pharmaceutical Industry is Speeding Up
The time-to-market has always been a concern for the pharmaceutical industry. But the development of a vaccine against covid-19 in just a few months and making it available within a year has left one speechless: How was/is that possible? What has the industry learned from this for the future? What can be adapted and what cannot? Insights from a web conference organized and hosted by PROCESS.
On the one hand, Covid-19 has been chaining us up for months, restricting us in our private and business lives. On the other hand, the threat of the virus has also broken chains in vaccine development and subsequent production — experts and politicians are enthusiastically seeing how quick the pharma industry can be. The alliance of Biontech and Pfizer achieved in ten months what previously took significantly longer: developing a vaccine, clinically testing it, getting it approved by regulatory authorities and bringing it to market takes on average ten to twenty years, sometimes even longer (source: Infovac, Geneva).
So, the rapid development and ramp-up of Covid 19 vaccine production has shown what is possible when the pressure is high enough. What can the industry learn from this? That’s what top-class experts discussed at our pharma web conference.
Becoming more agile, flexible and digital
So, if classical vaccine delivery takes years: Who or what is holding Pharma back so severely? Marcel Staudt, Vice President of ISPE DACH, knows a whole bundle of reasons: On the one hand, there are the lengthy phases of planning and commissioning plants. Some things are also due to the long approval and validation procedures. Last but not least, this is due to the pronounced safety awareness, which is reflected in multiple risk assessments.
To counter this, he particularly emphasizes the aspect of partnership: one should not think too long about financial aspects, should not always look for the cheapest supplier. Rather, every client should create a list of the most efficient (not the cheapest!) suppliers and simple supply chains. He also calls for thinking more in terms of standards and accepting standards — 100 per cent customized technology is not always desirable. His clear message: sewing hard on edges should be obsolete.
The demand for speed and acceleration applies first and foremost to plant planning and realization; the quality of the products and their release procedures must not be affected by this.
And last but not least: speed is more important than the complete exclusion of potential risks. Incidentally, he sees the best chances for more speed in the preliminary phases. For this, the administrative ballast (guidelines, etc.) must be reduced. On the question of speed, Staudt notes that: "The demand for speed and acceleration applies first and foremost to plant planning and realization; the quality of the products and their release procedures must not be affected by this. Nevertheless, the approval procedures of the plants by the authorities should be carried out quickly."
Balancing act between specialization and standardization
Plants are ageing, many sites in Merck's production network are more than 20 years old. Cost pressure then increases there, as Oliver Kärst, Head of Pharma Engineering at Merck, pointed out. The challenge here is to ensure delivery reliability with the lowest possible replacement investments. He presented the company’s own ‘Asset Management System’ as a solution.
The system has the central task of identifying the right time for a replacement investment. This requires the regular review of the availability risks of assets. Of course, the whole thing also has an influence on the company’s sustainability strategy. After all, what is invested today in terms of buildings and facilities will still be in place in 20 years — that has to be taken into account today.
Another important point is the ‘Technical Site Masterplan’ — among other things, this checks where the current capabilities of a site are and where capacities can be exchanged. Merck’s goal is to network sites worldwide. Digitalization plays a central role in this, says Kärst — and this is easiest with standardized plants.
It was asked, how does Merck deal with its suppliers on the issue of digitalization? Globally active service providers in terms of digitalization would definitely be preferred, smaller suppliers come up against the content-related limits of the pharmaceutical industry relatively quickly, was the answer.
Note 1: Oliver Kärst and Marcel Staudt were both surprised at how quickly the pharmaceutical industry is able to solve a specific task — although both are familiar with similar speeds in smaller projects (which, however, does not correspond to the standard).
Note 2: Even though the product development of the new vaccine by Biontech and Moderna was carried out by smaller companies (quasi start-ups), the production of the drug was rather carried out by Big Pharma and with the help of experienced suppliers.
What will the pharmaceutical plant of the future look like?
Martin Mayer, Head of Business Development Digitalization at Zeta, ventured a look into the future with his contribution. The focus was on the question: Which concepts can accelerate time-to-market?
In concrete terms: How can Ultra Fast Track projects be realized within 24 months? The first answer was initially disillusioning: according to Mayer, digitalization alone will not speed up the planning time. More important is the parallelization of the individual engineering steps. This is achieved through standardization, transparency (data management), fast communication and digital documentation — only integrated digital engineering leads to success. Mayer sees the importance of parallelization equally in the approval procedures in clinical product development.
To win the race against time, Mayer also recommends reusing existing data from previous projects.
Platforms, standards and modules
Cold chain tracking is indispensable for some vaccines. In addition, there are requirements regarding the quality of shipment tracking (Track & Trace). Experience has shown that both are often the first step towards digitalization at pharmaceutical companies, said Georg Schick (Strategic Product Manager Track & Trace) and Frank Bixenmann (Consultant Digital Solutions) at Uhlmann. The experts showed how pharmaceutical companies can use the data already available for more productivity and patient safety.
Uhlmann uses the Pexcite platform specially developed by the company for this purpose. It is important to know that just collecting data is not enough, the data must also be interpreted correctly. One participant asked what data is collected and with which sensors. Answer: Everything that can be detected by sensors can be recorded and combined. This can also be done by integrating it into higher-level monitoring systems.
"If you want to halve the time until a drug is ready for production, you have to standardize much more than before", says Andre Ammann, Key Account Manager Pharma Europe at Turck. Modularization with skids is an important aspect for the pharmaceutical industry. It becomes problematic when a skid supplier has to adapt to the different control system standards of its customers — this extends the procurement time. Turck’s solution: Multiprotocol gateways that adapt to different protocols. In addition, there is the use of IO-Link to connect and identify different modules.
The next step must then be the use of MTP (Module Type Package). This is already being investigated in individual pilot plants. The great advantage for the operator is flexibility. For example, the capacity or productivity of a reactor can simply be doubled by using another module via MTP, according to Turck’s experience.
Bürkert offers various devices and systems for the different sections and functionalities of a pharmaceutical plant. The challenge is to integrate these solutions into the higher-level automation through distributed or decentralized intelligence. Michael Rausch, Segment & Project Manager Hygienic, presented various solutions for this.
More pragmatism required
Covid-19 has shown strengths and weaknesses to the industry. What we have learned positively: We can indeed build plants much faster than before. In order to increase the speed of pharmaceutical product or plant development, a more pragmatic approach was favored in the discussion round. Specifically, the pharmaceutical industry should get involved with concepts that have already been tried and tested. For example, it should also take note of standard solutions from other industries in order to adapt them.
Interesting in this context is an article in a German daily newspaper (FAZ) in November: According to this, the US Government is planning to massively increase the production capacity for mRNA vaccines with the help of a subsidy program worth billions. A declared goal of the initiative is to be able to produce enough vaccines to supply the United States within 130 days after the appearance of a dangerous virus and the rest of the world within 200 days. The corresponding production capacity should be available as early as the second half of 2022.