More than 20 experts from the pharmaceutical industry joined the Roundtable "Factory of the Future" on December 9th for a day of real-life scenario discussions, case studies and best-practice sharing.
Read here about the most important findings on each topic:
MES Recipe Management
A digital platform like MES is key to dealing with customer-specific requirements and operating multi-product assets.
MES enables a high level of flexibility and configurability in the electronic master batch record required to support a fully digital tech transfer.
A digital plant will not only deliver high quality products (Golden Batches) but also valuable data sets and insights that can be shared and integrated into the customer systems.
The Lonza team has shared their experience and best practices to find the balance between using a global library of recipe objects, exposing process parameters while leaving room for the sites and asset heads to manage the equipment and product specific parametrization.
MES at CDMOs
CDMOs broadly understand the benefits that a digitalized production provides to their specific business models. However, due the business model of a CDMO, their requirements for an MES are going beyond most currently available MES solution who were designed according to requirements of MAH in-house commercial manufacturing facilities. CDMOs require an MES solution that can manage the flexibility and agility needed for a manufacturing environment that is determined by producing many different products for various customers. This has an impact on how MES responds to
- managing process variations based upon manufacturing orders from different customers
- flexibility to schedule manufacturing orders to allow best utilization of assets whilst the long-term production schedule is depending on customer orders
- providing access to batch information, ideally in real time, to customers, for example batch status dashboards
- allowing customers to review and approve master batch records digitally
Integrating customers into digital manufacturing of a CDMO requires strict segregation of customer data and an advanced cyber security concept.
Manufacturing Digitalization in Cell&Gene Therapy
The big challenge of CGT is the scalability of individualized medicines where 1 batch needs to be produced for 1 patient on an industrial scale.
The cost of CGT is still high and needs to be reduced to make it more accessible to patients. This can be achieved by leveraging automation and digitalization of the manufacturing process.
While MES enables the industrialization of CGT, is also the platform that maintains the integrity of the COI and COC and needs to be integrated into the vein-to-vein ecosystem. The integration should happen through an industry-wide API to avoid the complexity of multiple system being used across healthcare and biomanufacturers.
We’ve also discussed the need to deploy manufacturing capabilities at the point of care, where thousands of units will need to be installed in hospitals and care centers, posing an additional challenge for GMP operations.
Patient safety goes across the supply chain where chain of identity and custody must be secured to ensure that the right product is delivered to the right patient on time.
Advanced Analytics / Production Dashboard
As we increase the digital maturity of our plants, more data sources are available and need to be integrated and made available to generate business value.
On the shop-floor, a data historian plays a key role to connect and collect real-time process data that will be used to feed the advanced analytics engine that visualizes and controls operations.
On top of that, we need to create a “marketplace” where other sources like MES, LIMS, QMS systems are also integrated.
The full-value comes from the ability to orchestrate and automate the report generation and batch release.
Data analytics in the GxP space is fundamental to accelerate Tech Transfers on one end of the value chain and to release batches on the other end.
Want to learn more about the "Factory of the Future"? Click here to read our expert article.