As the saying goes, “time is of the essence.” This bit of wisdom rings true in the highly competitive life sciences industry where intellectual property (IP) – and patent protection – come with expiration dates.
Speed-to-market is an increasing concern as product moves further along the pipeline from discovery through clinical trials. And at one critical juncture, a company must determine how they will transfer technology honed in the laboratory environment to larger scale production.
The team tasked with this challenge is keenly aware that scaling up quickly is key to profitability. But determining the most efficient technology transfer strategy can prove vexing, to say the least.
Limited Capital – and Homegrown Systems
Technology transfer teams, typically comprised of both laboratory and operations personnel, face multiple issues. First, most early stage endeavors have limited financial resources.
Therefore, capital investments are based on the task at hand – providing scientists with laboratory tools directly focused on product key performance indicators (KPIs). Investing in technologies that efficiently capture data to guide larger scale operations is not a priority.
Data is still critical in the laboratory environment, of course. And given budget constraints, scientists often build custom solutions to meet their immediate needs. These homegrown data reporting systems are often “proficient enough” for early stage laboratory operations.
But disparate – and sometimes paper-based – systems are not sustainable in a production environment.
Transitioning to Digital Technology
Laboratory data is essential to commercial production. Consequently, making lab or pilot plant data easily accessible to digital automation systems is critical.
But when is the best time to begin the digital transformation of the process?
In early product lifecycle stages, introducing a fully automated system into a laboratory environment is overkill. Certainly, scientists should not be distracted from their work by complex automation systems.
The late clinical trial stage is perhaps the optimal time to introduce tools in the lab that can capture data in consistent digital formats production systems can use.
One approach: A modern DCS that can scale from user-friendly, software systems that are right-sized for labs to completely integrated plant-floor solutions.
A Compliant, End-to-End Solution
Basing digital transformation on a scalable, modern DCS delivers significant benefits – in both the lab and on the production floor.
Most critically, a modern DCS provides an end-to-end manufacturing solution that lays the foundation for electronic batch records (EBR), validation and regulatory compliance.
Every biologic and pharmaceutical formulation developed in a lab is based on sequential steps. A Modern DCS with electronic batch capabilities replaces manual processes with sequential flow and phase transitions in a structured manner. And it captures, formalizes and enforces required workflows.
From a regulatory standpoint, an EBR improves accuracy and data integrity – and eases 21 CFR Part 11 compliance. Integrating the DCS with manufacturing execution systems (MES) drives even more regulatory efficiencies.
In fact, more companies are speeding the transition to a production environment by applying a modern DCS and gaining regulatory approval on small bioreactors in laboratories. When the product is ready to move into the commercial pipeline, the DCS can quickly scale up.
More Efficient. Future Ready.
A modern DCS can use analytics tools to convert raw data into actionable information that can impact operational and equipment efficiency from the lab through production.
For example, the system can analyze thousands of data points in a lab to quickly uncover correlations and causations that may otherwise remain hidden. On the plant floor, the modern DCS can deliver batch and equipment analytics to help keep systems running optimally.
Of course, a biologic or drug once produced by a limited number of facilities may one day be made by a network of contract manufacturing organizations (CMOs). By choosing a modern DCS from a recognized, globally supported automation provider, life sciences companies can more easily maintain consistent supplier selection downstream – wherever production occurs. And maintaining a consistent modern DCS worldwide helps allay concerns regarding repeatable production runs.
The post was co-authored by Tim Schmidt, Global Process Marketing Lead, Rockwell Automation