Digital Manufacturing for Pharmaceuticals
About the Customer
The customer is a global pharmaceuticals company and manufacturer focused on the treatment of rare diseases like hemophilia and primary immunodeficiency. The company's products are available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders and Oncology, amongst others.
The Customer’s Challenge
With one of the most challenging and stringent regulatory environments of any industry, requires meticulous adherence to quality standards and process controls. Today, patient safety is the number one priority, as it should be. However, the complexity of government regulations in the Pharmaceutical Manufacturing has created many challenges for the manufacturers of modern pharmaceuticals.
The extreme focus on quality slows everything down. Completed drugs take longer to get into the hands of patients. New drugs take longer to be developed. New technologies take longer to be adopted. Quality control is expensive too, and it contributes to driving up costs for both the manufacturers and the patients. The customer is a leading global biotechnology manufacturer who faced these same challenges.
Business Drivers
- Achieve paperless manufacturing process
- Global standardization of plant systems
- Reduce rework, deviations, research time and costs through automated error checking and process controls
- Improve regulatory compliance driven by built-in cGMP features and complete manufacturing traceability
- Improve process visibility with built-in GxP reporting and genealogy features
- Ensure internal end user adoption and acceptance
About the Project
Engineering Industries eXcellence has worked with the customer over the past 7 years to help them digitalize their manufacturing, automating processes and reducing the use of paper by 90% at facilities across North America and Europe. To achieve this transformation, our team of experts led a multi-year, multi-site effort to customize and implement a full-featured Manufacturing Execution System (MES) with Electronic Batch Records (EBR) management capabilities at various existing and greenfield plants.
Project Activities
- Designing and deploying a customized Manufacturing Execution System (MES) for batch record management based on Siemens Opcenter Execution (SIMATIC IT) eBR Software
- Providing consulting and technical leadership before, during and after system go-live at plants across the U.S. and Europe
- Supporting computer system validation of new system according to GAMP standards
- Delivering software end user training and support
- Providing remote MES administration, maintenance and IT support services
Engineering's Advantage
Thanks to the digitalization of their manufacturing process, the customer's operations have become significantly more efficient and controlled. Digital Manufacturing means most quality checks happen in seconds, not hours. This speeds up production and enables the customer to produce more medicine at higher quality specifications. As a result, medicine that is critical for those suffering with some of the most debilitating diseases in the world can get to more people, faster and at a lower cost to both the manufacturer and the patient.
Engineering has had a consistent presence in the life science industry, including pharmaceutical and medical device manufacturing, for over a decade. The industry has historically been characterized by a reluctance to change processes and adopt technology due to regulatory constraints and pressures. This approach has started to change in recent years, however, as the FDA and international regulatory agencies have started to embrace innovation more and more. Engineering Industries eXcellence has been on the forefront of this transformation, guiding manufacturers and facilitating the adoption of Industry 4.0 technologies aimed at improving quality, reducing patient risk and increasing data transparency.
