There’s nothing more disastrous for a pharmaceutical company than having to recall a batch of medication. Over the years, companies have recalled drugs for many reasons such as the presence of carcinogenic impurities, bacterial contamination, incorrect labeling, or even toxins unintentionally produced by reactions involving chemicals. That’s why batch management plays a crucial role in the life sciences industry.
Proper batch management ensures quality, compliance and traceability throughout the manufacturing process. Batch records document every step of the manufacturing process, including raw material sourcing, equipment used, procedures followed, and test results.
“We know the requirements of the industry very well due to our very close cooperation with the leading life sciences companies worldwide,” said Stefan Kubick, Partner at Tenthpin Management Consultants, during a recent presentation about the SAP Batch Release Hub for Life Sciences solution, (SAP BRH).
Digital leadership
Tenthpin, a global consulting and technology boutique company 100% focused on life sciences, has the world’s richest experience and the best talent in designing and delivering batch management and release solutions. Tenthpin was awarded by CIOReview as one of the most promising SAP solution providers and transformations partners 2023 and is SAP’s premier co-Innovation partner and the lead system integrator in this area.
“Our goal is to design and build innovations based on the SAP product suite to set new industry standards together with leading companies of the industry,” said Kubick.
According to Kubick, the leaders in batch management are companies that embraced digitalization early on by adopting Industry 4.0 principles and integrating digital solutions such as advanced data analytics and cloud industry standard solutions. This allows for greater traceability, faster throughput times, and efficiency in batch processing.
Using state-of-the-art facilities that apply advanced technologies like continuous manufacturing and automation increase efficiency, reduce human error, and improve quality control. Some companies are also pioneering the use of single-use technologies in biologics manufacturing, which simplifies batch changeovers, reduces contamination risk, and improves flexibility in production.
Increasingly, there is a focus on personalized medicine requiring the production of small, highly specialized batches of pharmaceuticals. Companies must now excel in managing small lots, especially in personalized cancer therapies, to meet the growing demand for individualized treatments while maintaining quality at scale. This poses a unique challenge in batch management, as smaller batches must still adhere to rigorous quality and regulatory standards.
Collaborative mindset
Referring to the co-innovation project with SAP that led to the creation of SAP BRH, Kubick explained that SAP S/4HANA is the heart of most IT system landscapes. However, there was a need for an additional application that would better leverage custom built legacy tools in a compliant and intuitive fashion.
“Many systems relevant for release processes including quality control, testing, and deviation management are not available in SAP,” said Kubick. “We needed a tool to collect all relevant release data, one that could manage market releases, for example, in different countries with different regulations.”
Tenthpin engaged with SAP and its customers to design and build the new tool in just 18 months. The goal was to enable instantaneous release with a standalone option integrated to SAP S/4HANA. Exceptional collaboration was required in order to incorporate lean principles, simplify system landscapes to enable lean data flow and to apply industry good practices.
The new tool offers the flexibility not only to manage batch releases but also different release steps involving components and materials. The tool enables release management using different models for different types of releases. It can also tailor activities to meet different stakeholder requirements such as country-specific requirements, including regulations throughout the entire network.
Adding business value
SAP BRH is symbolic of a visionary approach to bringing the life sciences industry to the next level. According to the team at Tenthpin, the true value of the hub is that it centralizes all the data required by all the players in the process. Having all data in one place enables faster decision-making at each of the multiple points in the supply chain, significantly improving supply chain performance and inventory management, reducing order fulfillment lead time, and improving employee productivity.
According to Kubick, now is the time for life sciences companies to prepare for future growth. Crucial steps include enabling faster batch release cycles, scaling up manufacturing capabilities, and embracing future business models and therapy trends by working with smaller batch sizes. These steps will help companies stay ahead of the curve on their quest to prevent or even cure diseases and improve health outcomes for patients and healthcare systems around the world.
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