Lonza’s MODA-ES™ Platform helps Nephron Pharmaceuticals move from paper to an EBR in nine months – Case study to be presented at 2019 ISPE Annual Meeting
- Lonza has partnered with Nephron Pharmaceuticals Corporation to implement Lonza’s next-generation MODA-ES™ EBR Platform to streamline manufacturing compliance reporting
- The MODA-ES™ Platform was implemented at Nephron in an aggressive nine-month time frame, improving operational efficiency and enabling a significant product line expansion
- Full results of the collaboration will be co-presented by Lonza and Nephron at the 2019 ISPE Annual Meeting & Expo in Las Vegas, Nevada
"Pharmaceutical manufacturers are increasingly turning to electronic batch record solutions to overcome the inherent inefficiencies of paper-based workflows. Nephron was one such company, looking for an affordable, flexible platform and a partner with the expertise to implement a solution to a very ambitious timeline. Lonza partnered with Nephron to simultaneously develop and implement the MODA-ES™ Platform in just nine months, and the resultant efficiency gains facilitated a significant expansion of Nephron’s 503b manufacturing operations."
Bryan Beck, VP Information Technology, Nephron Pharmaceuticals:
"Recording a wealth of batch and quality data on paper had become a significant bottleneck in our attempts to react rapidly to market product shortages and to expand our manufacturing operations. However, we found most EBR solutions on the market didn’t meet our needs, particularly in terms of cost, flexibility and configurability. We wanted the ability to modify EBR workflows to accommodate our changing manufacturing processes without having to start from scratch each time or re-engage with suppliers, and we needed this rapidly — Lonza’s expertise and the MODA-ES™ Platform allowed us to do this."
Basel, Switzerland, 3 October 2019 – During the 2019 ISPE Meeting & Expo (27–30 October, Las Vegas, Nevada), Lonza and Nephron Pharmaceuticals Corporation will co-present the results of the first implementation of Lonza’s MODA-ES™ Platform, a next-generation electronic batch record (EBR) solution for the pharmaceutical manufacturing industry. Lonza partnered with Nephron, a global leader in the manufacture of generic respiratory medications, to implement the MODA-ES™ Platform, overcoming a number of implementation hurdles and completing the process in an accelerated nine-month timeframe. The successful implementation of the platform has delivered significant operational efficiency gains at Nephron, improving the quality of batch record data and enabling the rapid expansion of its product line without increasing company headcount. Lonza and Nephron will present detailed results of the collaboration on Sunday, October 27 from 13:00–15:00 as part of the Information Systems Track at the ISPE 2019 annual meeting.
The transition to an Electronic Batch Record has immediate advantages over paper-based documentation, eliminating human error, increasing efficiency and expediting product time-to-market. These benefits are particularly important for pharmaceutical manufacturers wanting to expand their production to meet the rapidly growing global demand for pharmaceutical products. However, such solutions have previously been out of reach for many on account of their prohibitive costs and the great complexity of the implementation process.
Lonza’s MODA-ES™ Platform has been specifically developed to offer a flexible and cost-effective EBR solution, providing an opportunity for a wider portion of the pharmaceutical manufacturing industry to go paperless. The platform combines streamlined data capture and error prevention capabilities with a highly configurable, user-friendly modular design. This means that scaling to a paperless workflow is rapid while offering users the ability to modify manufacturing and quality control data processes to their specific requirements.
The workflow-driven data entry in the MODA™ Platform is also applicable to cleaning forms and capturing QC data, and the platform can be easily integrated with other GMP-compliant electronic systems and analytical equipment, allowing users to reliably transfer data across their manufacturing and quality-checking infrastructure.
The workshop, titled ‘Paper to EBR in Nine Months — How a Strong Collaboration Leads to Project Success’, will be delivered by Geoffrey Swafford, Senior Product Strategist at Lonza, and Bryan Beck, VP Information Technology at Nephron. The workshop will give delegates the opportunity to gain insight into how strong collaboration between vendor and customer can overcome the challenges and complexities of an EBR implementation at a small-to-medium sized company. More specifically, Lonza and Nephron will discuss:
- Nephron’s need for a cost-effective EBR solution to rapidly expand its 503b operations in response to increasing product demand
- Why Lonza’s MODA-ES™ Platform was the preferred EBR option for Nephron
- How Lonza partnered with Nephron to coordinate the parallel development and implementation of the MODA-ES™ Platform, delivering against an aggressive nine-month timeline
- How project risks were identified, managed and turned into successes through a solid vendor-customer partnership
- How the MODA-ES™ Platform helped to significantly increase Nephron’s operational efficiency and enabled its product line to expand from 25 to 75 different products
Lonza is an integrated solutions provider that creates value along the Healthcare Continuum®. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.
Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. Further information can be found at www.lonza.com.
Nephron Pharmaceuticals Corporation develops and manufactures safe, affordable generic inhalation solution and suspension products specializing in Blow-Fill-Seal technology. In addition, the company operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. In accordance with the DQSA draft guidance, the company follows cGMP, GDP and all quality expectations. The company has been licensed by the Food and Drug Administration. Nephron received a 2017 ISPE/FOYA innovation award for the high level of automation present throughout the facility. For more information, please visit www.nephronpharm.com.
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