Contract development and manufacturing organizations (CDMOs) face unique challenges. They’re outsourced to handle drug and therapy development as well as to manufacture pharmaceutical, nutraceutical, and biological materials. And beyond that, they are often a key part of research and development prior to manufacturing as well.
Life science companies and organizations often rely on CDMOs to bring new formulas and products to market faster without the investment risk of building additional internal infrastructure. Hence, CDMOs need to meet the demands of multiple clients, products, and batch sizes, all while remaining flexible enough to assist current and future clients.
The challenge for CDMOs is to grow and adapt without being limited by current business processes and systems. And many of them have found that enterprise resource planning (ERP) software is the solution they need to improve operational performance through digital transformation.
One such organization is the Pennsylvania-based Center for Breakthrough Medicines (CBM), a CDMO that recently engaged Navigator Business Solutions to help them drive innovation, grow their business, increase market share, and become a leader in the industry.
CBM Implements an ERP System as a Foundation for Strong Growth
As one of the leading CDMOs in the United States, CBM provides a full spectrum of services to companies working on pre-clinical to commercial phase therapies, all in one fully integrated location. This allows them to accelerate speed to market and deliver the highest quality with one end-to-end, single-source solution.
Shortly after their launch in 2020, CBM began looking for an ERP system. Joerg Ahlgrimm, CBM’s CEO, cited their rapid growth—with 700,000 square feet of ongoing build—as just one reason for their need for ERP. “We decided we needed to put in the right foundational platforms as early as possible,” he said. “Navigator helped us do this the right way.”
To maintain their competitive advantage, CBM installed SAP Business ByDesign, an ERP solution implemented by Navigator. Steve Gwynn, CBM’s director of enterprise systems, says, “We needed a GMP-validated system to support regulated manufacturing and development processes.” That’s why the company chose SAP Business ByDesign, which is “an out-of-the-box, fully integrated system,” he said.
SAP Business ByDesign was just the right match for CBM’s needs. Gwynn was directed to choose a GMP-validated system that was easy to use, since it was meant to be used in one way or another by most of CBM’s employees. To that end, Navigator ensured that CBM staff were well-trained on the system by providing structured training vignettes on its functions.
Navigator also sent a project manager who spent weeks onsite in Philadelphia, using his intimate knowledge of the system to help with the project’s significant complexities. All this allowed CBM to get its ERP up and running in just 10 weeks instead of the usual 6 months to 2 years required for ERP implementation—an impressive timeline, given the complexity of the task.
Beginning in February 2021, financial processes were fully implemented in seven weeks, while other processes, including warehousing, logistics, supply chain planning, manufacturing, and quality, were completed over the next seven months.
CBM is dedicated to drug and therapy development that can alleviate the lack of capacity that prevents patients from accessing needed cell and gene therapies. Their new ERP system is part of a multi-tiered strategy that uses automation, digitalization, business process excellence, and technology innovation to build the largest CDMO for advanced therapies.
“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,” said Peter Carbone, CMB’s COO.
Read the full success story here
Digital Transformation in the CDMO Market
As COVID-19 spread throughout the world in 2020, CDMOs were called on to help expand American capacity to manufacture drugs and therapeutics related to the pandemic—vaccines in particular. This imperative forced CDMOs to reexamine the limited and disconnected business systems that are holding them back from achieving their true growth potential.
Strategic updates in technology, such as ERP for CDMOs, can be instrumental in meeting this imperative and ensuring that they can deliver constantly to clients, efficiently increase future capacity, and uphold regulatory guidelines. This can be the right solution when CDMOs find that their current business processes and systems are limiting their ability to grow and adapt.
Biotech and pharmaceutical materials are becoming increasingly complex, and life science companies are faced with new problems and obstacles in development and manufacturing. Given the increasing range and high cost of equipment needed as well as the cost of facility development, CMDO companies are naturally trying their best to balance cost, quality, and speed.
To meet these and any other future challenges, ERP for CDMOs—particularly solutions built for and that take full advantage of cloud computing—can be just what the life sciences industry needs.
For more on how ERP can help life science firms, call one of our consultants at (801) 642-0123 or email us at info@nbs-us.com.