[VIDEO] Leveraging the power of cloud in biotech at Univercells

Mar 21, 2024
  • healthcare
  • SAP

Univercells, a trailblazer in the modern life sciences sector, is spearheading innovations worldwide. Backed by the Bill and Melinda Gates Foundation and many others, this Belgian company is on a mission to make biologics — medicines derived from natural sources — more accessible and affordable to all. How? By developing smart technologies and enhancing process efficiencies for therapy innovators from pre-clinical to commercial GMP

  • Client: Univercells, a global life sciences company with a singular focus: making biologics accessible to all.
  • Challenge: Set up a mission-critical shared IT environment for Univercells five affiliate companies and the holding company. 
  • Solution: SAP RISE, SAP’s (private) cloud-based SAP S/4HANA solution, offering powerful technology and out-of-the-box compliance for pharmaceutical companies. 

Univercells’ journey to SAP RISE 

Univercells is a biotech group with five affiliate companies (Exothera, Quantoom Biosciences, RLM Consulting, and Unizima) that cover several parts of the healthcare spectrum and are linked by a unified, cloud-based IT system built on SAP RISE, expertly implemented by delaware. 

The challenge: a mission-critical shared IT environment 

“It’s not enough for a treatment to simply exist,” says Nohad Laamim, Chief Digital Officer at Univercells. “To really make a difference, we need to make it accessible to anyone. First and foremost, we must drive down the cost of production through technology. Our approach is twofold: on the one hand, we develop innovative biomanufacturing equipment that enables low-cost, low-footprint, and high-quality biologics production. On the other hand, we provide therapy innovators with access to expertise and manufacturing capacity, from the pre-clinical phase to commercial ‘good manufacturing practice’ or GMP.” 

Each of the 5 affiliate companies completes a specific piece of this complex puzzle. As the holding company, Univercells provides centralized services, including IT and digital services, ranging from service desk and data analytics to larger digital transformation projects, such as laboratories’ digitalization and SAP implementation. But since each entity has its own value proposition, unique requirements, and level of process maturity, alignment and harmonization are quite challenging.   

“Running the same technology is essential to secure a decent level of governance (for finance, supply chain, quality),” Nohad explains. It also ensures a smooth data flow for better  visibility and steering, and helps keep the IT costs in check. Moreover, our affiliates need a powerful and scalable IT environment to stay ahead in a very competitive field. That’s why we had to move as fast as possible from a basic ERP to a more robust cloud solution with a wide range of capabilities, including GxP compliance.” " 

What is GxP compliance?  

GxP compliance refers to a collection of regulations and quality guidelines designed to ensure that bio/pharma products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution. The "G" stands for "Good" and the "x" stands for the various fields like Manufacturing (GMP), Laboratory (GLP), Clinical (GCP), Distribution (GDP), etc 


For an ERP system to be GxP compliant, it must support the creation, management, and tracking of products in a way that complies with the regulatory requirements. This includes features that ensure:   

 

  • Traceability: The ability to trace the entire lifecycle of a product from procurement of raw materials to production, distribution, and delivery to the customer.  
  • Documentation: Proper documentation practices that can record every process and change in a transparent and auditable manner.  
  • Quality control: Integrated quality control mechanisms to ensure that the products meet the required standards.    
  • Validation: The system itself must be validated to show it works as intended and that it consistently produces the expected results.  .  
  • Data Integrity: Robust data integrity and security features to protect sensitive information and comply with regulations, including computerised systems, like FDA 21 CFR Part 11 and EU GMP Annex 11.   

The solution: Head-first into the cloud 

Finding the right solution for an organization as complex as Univercells is not an easy task. Nohad: “The ERP system covers 8 business domains, from financial controlling and production to procurement and quality assurance. All these different capabilities should be somehow understood and integrated into a single system. Over the course of 6 months, we assessed a range of solutions and partners in terms of business fit, total cost of ownership, regulatory compliance, experience, and ability to execute. Important to note is that we always considered technology and the integrator together. You can have the best tool in the world, but without the right integration team who understands your complexities and uncertainties, you’ll never leverage its full potential.” 

“In the end, SAP RISE and delaware proved to be the best combination for us. SAP covered ca. 80% of our business requirements right out of the box. And despite being a Tier 1 ERP solution aimed at the challenges of the world’s largest and most complex enterprises, the pricing was very competitive. Meanwhile, delaware convinced us of their expertise and experience from the get-go. Throughout the project, their consultants showed skill and commitment in the way they approached the numerous challenges that emerged. This enabled us to develop the remaining 20% of requirements that are instrumental to Univercells, including our stringent procurement process, customized KPI, and reporting.” 

“SAP RISE offers a completely validated environment,” adds Patrick Carmans, Partner at delaware. “In life sciences, this is important, since everything needs to be traceable to be GxP compliant. SAP guarantees that the infrastructure setup is well documented and repeatable, and that only qualified personnel can touch it. In this way, the pharma player can prove that the system is under their full control.”  


Throughout the project, delaware’s consultants showed skill and commitment in the way they approached the numerous challenges that emerged. They clearly understood our way of working, industry and processes, and this made it possible to bridge the gap between business and IT
Nohad Laamim, CDO at Univercells

The result: Bridging the gap between business and IT 

“delaware’s consultants clearly understood our industry and processes, which allowed them to bridge the gap between business and IT,” Nohad continues. “This unique combination of industry insights and technological expertise allows us to make the most of SAP RISE, like improving efficiency and cost-effectiveness, and the ability to scale fast in a competitive industry.”   

“Apart from that, the goal was also to provide the business (operations and management) with data analytics capabilities. This meant we needed people who understood the data model of SAP S/4HANA and the critical information the business needs for its decisions. The team was able to generate critical reports, e.g., for the supply chain team leveraging our Azure Data analytics platform at go-live. While this wasn’t included in the initial project scope, Patrick and his team went above and beyond to make it happen. There was a direct line between me and him, and I found him very accessible. And while an immediate solution was not always available, the team was always committed to finding one.”    

This wasn’t an IT project as much as it was a company project: it’s only through the full commitment of everyone at Univercells and at delaware that we were able to pull it off
Patrick Carmans, Partner at delaware 

User adoption is an endless journey,” adds Patrick. “This is particularly true for a complex system like SAP RISE, which takes a significant amount of time to understand and utilize fully. In a transformation process like this, we cannot afford to lose track of the human aspect. This wasn’t an IT project as much as it was a company project. It’s only through the full commitment of everyone at Univercells and at delaware that we were able to pull it off.”   

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