Today, pharma is one of the world’s most rapidly advancing industries, considering the quick development of the COVID-19 vaccine — with 48 candidate vaccines already in clinical evaluation.
Here, Giuseppe Menin, Industry Manager of industrial software provider, COPA-DATA, gives his three predictions for pharmaceutical manufacturing in 2021.
Close the data integrity gap
An essential component for modern pharmaceutical manufacturing is clean, relevant and accurate data. According to a report by Zenith Technologies, data scientists spend around 60–80% of their time analysing data before they gain any insights.
Managing data as paper-based process is not only longwinded, but is prone to errors. In the future, all records must go digital. Digital data systems are essential for optimising data capture and analysis.
Opting for an Automation Integration Layer onboarding data from existing equipment or carefully selecting a Pharma 4.0 ready new machinery, pharmaceutical manufacturers will benefit from fewer errors at each phase of production.
That’s not to mention the advantages in data integrity compliance of keeping clean, digital records in a regulation-heavy industry.
Modular and flexible production
Personalised medicine will continue to gain momentum in 2021, with manufacturers producing smaller, and often customised, batches.
One method to achieve personalised medicine is through modular manufacturing. Modular manufacturing allows pharmaceutical processors to produce a variety of products from a single facility, without the extensive changeovers associated with traditional plant.
In fact, 2021 will see more pharma processors opt for ‘ballroom’ concept plant. Ballroom facilities are defined as large manufacturing areas with no fixed equipment. This approach allows a facility to be broken down into functional building blocks, allowing for plug-and-play manufacturing and total flexibility. This is a trend in biopharmaceutical facilities.
For example, COPA-DATA’s zenon software is able to map out the entire process sequence. Take a plant, for instance, that is made up of multiple autarkic modules, with each digitally mapped to a certain process step.
This LEGO-like principle provides an efficient way of rearranging the individual plant blocks to suit whichever application, helping with the industry increasingly demanding reductions in the time to market.
Even now, there are modular and interoperable process automation initiatives, such as ZVEI/NAMUR MTP, which enables a plug and produce approach.
However, to enable this approach, an orchestration software platform is essential. According to MTP, Process Orchestration Layer (POL), acts as the glue that binds different machines together.
Once equipment introduces its capability to the POL, the POL then sends commands to all equipment, according to a defined product recipe.
A paradigm shift toward a service-oriented architecture
Digitalisation is not a new phenomenon in pharma, but it is often seen as an option rather than a necessity. In some cases, mid-sized manufacturing enterprises (MSEs) cannot afford the investment of monolithic centralised IT systems.
Whereas plants in bigger organisations will include automated and digitalised areas, with other areas of the facility operating independently as a digital silo.
Therefore, a new approach to software architecture is required. For instance, modular and scalable software services are easier to validate and are more affordable for MSE companies.
This is why the International Society for Pharmaceutical Engineering’s (ISPE) Pharma 4.0 is promoting a paradigm shift from solutions based on centralised software systems to service oriented architectures.
This ensures machines and different software services can simply exchange data in a reliable and validated way, so that the user can easily and uniformly access information from different data sources, wherever he is.
The manufacturing and compliance challenges are forcing the life science industry to move away from digital silos and toward fully integrated plant.
Modular solutions must fit in both existing equipment and new "Pharma 4.0 ready" machinery.
COPA-DATA’s software platform, zenon, can support a company’s digital journey. Capable of acquiring, processing, storing and sharing data, zenon can communicate across existing equipment and other IT systems, making it suitable for plants of all age, manufacturers and communication protocols.
For instance, in greenfield scenarios where there is no need to work within the constraints of existing infrastructure, plant operators can rely on zenon to find out more about modular production, Pharma 4.0 and data driven analytics.
From the dubious pharmacy trading of the early nineteenth century, to the advanced technologies of today’s quick development of the COVID-19 vaccine, pharma moves fast.
Looking to the future, 2021 is set to see a more flexible pharmaceutical production thanks to the essential support of pervasive digitalisation.