Reducing time to market with digital technology in pharma manufacturing
Using digital technology in pharma can help speed time to market, enhance recipe transfer and enforcement, and improve quality and production efficiencies from the laboratory to the consumer. This is precisely what Tata Consultancy Services (TCS) achieves using PLM solutions such as PTC Windchill. Its solution provides a digital thread, enabling pharma companies to easily standardize, integrate, and extend recipe and production data across the enterprise.
In this PTC Talk, guest speaker Harish Rao, Managing Partner – Digital Thread Advisory at Tata Consultancy Services, explained how digital technology in pharma helps bring drugs faster from the lab to the patient.
How is digital technology in pharma helping optimize production?
When engaging with many of its pharma customers, TCS witnessed significant investment in the manufacturing sector to improve operational efficiencies, but the benefits from this investment needed to be improved. This lack of results was primarily because of the data quality coming from the process development stage - in discrete manufacturing, it is product development, and in pharma manufacturing, it is process development. The data being transferred from process development to manufacturing and the structure in which it was being delivered limited the ability to leverage the investment in manufacturing operations.
In a typical drug development process, once the discovery team identifies the target molecule, it is passed over to the process development team to take the initial recipes and scale them up to achieve consistent quality and quantity of yield. But today, the scale-up process is highly manual because the recipe that drives this process is manual; it is usually written in a Word document format, and the information is exchanged through document transfer in the form of work instructions and SOP.
The scale-up process is highly iterative, and any alteration to the recipes must be evaluated during their trial stages, whether at a lab scale or a clinical plant scale. The recipes are exchanged between the authoring and the execution system to execute the test batches and see how the recipe yields. This is an iterative process, and based on the feedback from the execution system, the parameters are reset, and the recipe is rerun.
This process has a vertical exchange of data that occurs manually. Once the recipe is matured or proven, it must be transferred to the next plant; that happens manually by exchanging documents. The typical problem pharma manufacturers face is using point solutions at the authoring and execution levels. They might use Word documents, a manufacturing execution system (MES) such as PTC's Windchill, or a lab execution system (LES).
The handoffs between these layers are manual and highly time-consuming. A significant challenge is that these disparate systems do not follow consistent semantics. Every time the batches are run and a report is required, a lot of mapping needs to be done for the information to make sense; this is a significant impediment to this entire process, reducing the operational efficiency in this field. This is the space that TCS decided to address.
What is the solution to the data exchange challenges for pharma manufacturers?
Most pharma companies already use a PLM package to manage the delivery devices and packaging, but not the drug itself. The PLM is used to collect the artifacts generated during the device design and the packaging design; what was missing was the drug information. Integrating this information was crucial to leverage the customer's investments in PLM and show them how the recipe could be managed within the PLM. Achieving this integration would not only give them a financial benefit but also provide a single-window view of the complete product, the product on the discrete side, and the process view of the product. This integration can be achieved within PLM because it is robust in configuration management capability, making it possible to configure the product with the appropriate device and package for all the different SKUs, which represent the different product variants; this is a core capability of PLM.
To achieve that, TCS had to set up the recipe management solution within the PLM. Most recipes are written in a storyboard containing four elements that constitute the recipe - equipment, materials, actions, and parameters. If you parameterize all these four in a structured way, it would be possible to standardize the way the recipe could be authored.
The TCS solution depends on three key steps. First, you must be able to standardize the recipe's elements. This standardization was achieved using the library management capability of PLM. PLM was leveraged to author the recipe and provide the recipe elements that constitute the recipe through a library, allowing the entire process to be standardized. Together, the equipment, materials, process actions, and parameters created a model through the library capability of PLM. The equipment and material could be site-specific so that when you generate a plant-specific or a site-specific recipe, you could easily configure that recipe to the resources available in that specific plant.
The second step was to digitize the recipe to create a structured construct to create the recipe. The base for this was the S88 industry-standard construct. The standard says that every recipe can be broken down into the different stages in which the drug will be produced. Each step could contain several operations, each with several actions. Each of these elements will have its own materials or equipment definition, and they will have two kinds of parameters: one is the process parameters, which drive the recipe, and the second one is the monitoring of the quality parameters. These four elements - materials, equipment, process parameters, and performance indicators - come from the resource library.
The third step was to establish the digital thread. PLM has the recipes and understands the other elements, such as packaging and raw material, so it can automatically create a BOM. Most importantly, this recipe has a structure that can connect to upstream and downstream operations. In the upstream, you can connect it with the lab systems so that all the test methods or testing operations can be automatically triggered from the recipe. Downstream, once the recipe is proven and frozen, you can transfer it to the various locations where it will be manufactured.
What benefits have pharma companies gained by using this digital technology?
With everything managed through the resource libraries, there are significant benefits for pharma manufacturers. There would be a considerable amount of information reuse in the region of 70 percent, and technology transfer would improve by up to 40 percent. Regarding financial results, Opex can be lowered by up to 20 percent, and a 20 percent reduction in time to market can be achieved. Within the highly competitive pharma manufacturing sector, these improvements are impressive.
To learn more about the opportunities that digital technology in pharma manufacturing presents and how the digital thread can help bring drugs to market quicker, watch the full Talk here.