The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) focused on addressing the challenges associated with manufacturing advanced therapies, sought to install an Enterprise Resource Planning system to support its continued expansion and rapid growth and provide the highest level of responsive service to clients.
Navigator Business Solutions was the partner of choice to implement the installation of an Enterprise Resource Planning (ERP) system to support the CBM’s efforts to provide the highest level of manufacturing support for its life sciences clients. Navigator was tapped by CBM to drive the installation of SAP Business ByDesign, a GMP validated system that supports the organization’s finances, client project management, supply chain planning, logistics, warehousing, manufacturing and quality and procurement. SAP Business ByDesign is an out of the box, fully-integrated system, that is capable of supporting regulated manufacturing and development processes
Steve Gwynn, Director of Enterprise Systems at CBM, touted the services provided by Navigator and noted that this engagement will be pivotal as the organization continues on a robust growth pathway. In Navigator, Gwynn said CBM found a partner that would be able to stand “shoulder to shoulder” with the organization through its robust growth plans, which includes a current build-out of 700,000 square feet of manufacturing space, as well as ramped-up hiring of hundreds of new employees. With recent available capacity for viral vector and cell therapy GMP manufacturing coming online and significant financing from South Korea-based SK Pharmteco, Inc. the organization is well on its way to becoming the largest single site advanced therapy CDMO. This ongoing productivity and expansion necessitated the addition of the ERP system. Gwynn said Navigator will be able to provide for CBM’s current and future needs as the organization provides end-to-end production services for their customers, all in one location lowering risk and optimizing efficiency for CBM’s customers.
Throughout the implementation of the ERP system, Gwynn said Navigator provided essential training on the new program through easy-to-understand videos and guides. It made for an easy understanding of the system and also allowed for quick feedback from their own teams. All of the details associated with training were coordinated by Navigator and the company provided standard operating procedures for training purposes, Gwynn said.
With Navigator’s assistance, CBM’s ERP was up and running within 10 weeks, which Gwynn said was impressive. What made it even more impressive is the fact that there were few issues with the implementation that delayed the rollout. Gwynn said that was due in no small part to Navigator’s structured approach that utilized accelerators, including numerous worksheets and checklists.
“ERP systems are not known for going in quickly and effectively. On the front it seems simple…. But it’s very complex because there are so many integrated areas. If you don’t do it right, it can fall apart quickly,” he said. “We needed to be able to do this right the first time. With Navigator’s expertise, it worked out well.”
CBM, based in King of Prussia, Pennsylvania, has been selected as the partner of choice by many clinical and commercial advanced therapy companies to support their development and manufacturing needs. CBM offers pre-clinical through commercial manufacturing capabilities including process development, plasmid DNA, viral vector, cell therapy and a full suite of testing and analytical capabilities. The contract manufacturing and development organization received a significant feather in its cap last year when it partnered with the University of Pennsylvania Gene Therapy Program, helmed by world-renowned scientific researcher Dr. Jim Wilson which has provided CBM with access to a gene therapy platform that can be used to help its clients accelerate their therapies to patients even faster.