MISHRA: For the last 35 years, ELPRO has served the world’s leading life science and healthcare companies. What is your assessment of the failures of the industry to deliver medicines safely for patients?
BAMERT: While many saw failure in global cold supply chains during the pandemic and beyond, we saw opportunity. The cold chain crisis has accelerated the growth of much-needed infrastructure improvements for ultra-low applications during shipment and storage. At the same time, demand has increased for end-to-end supply chain visibility for critical, life-saving medicaments. This growth will benefit patients in terms of accessibility, safe storage, and distribution.
MISHRA: What are the links in the supply chain that must be monitored for safe delivery of drugs to the patient?
BAMERT: Drugs and advanced therapies are highly regulated. The monitoring requirements from manufacture to patient are complex. Throughout the cold chain, there are many depots and stakeholders involved. Thus, many chances for failure and error if stability budget and environmental factors are not closely monitored, analyzed, assessed and archived. Validated solutions like ELPRO’s LIBERO Cloud provide peace of mind and the supply chain visibility that logistics, operations and quality managers need to facilitate compliant, safe, temperature-controlled storage and shipment to patients.
MISHRA: What is your estimate of the magnitude of the problem and what are the primary causal factors?
BAMERT: Millions of dollars can be at stake if pharmaceuticals are lost, damaged or spoiled during shipment or storage. According to a study by IQVIA Institute, the pharmaceutical industry loses around $35 billion annually for temperature-related issues. Not to mention the potential for litigation. In the case of advanced personalized therapies, mistakes can even result in loss of life. Not having visibility to shipments and a close watch on temperature control and the stability budget is a primary cause. In many cases that we see, human error is also to blame. Having the right monitoring solutions with the appropriate alarm settings, redundancy and remote notifications can help manufacturers, operations and logistics teams successfully manage the risks, accelerate corrective action response times and help prevent failure.
MISHRA: How well are the requirements for temperature control defined for the links of the supply chain?
BAMERT: Temperature requirements, stability budget assignments to different supply chain legs, and other tolerance ranges are typically set forth in the standard operating procedures (SOPs) by drug and therapy manufacturers.
MISHRA: Realizing that the end-to-end network for a shipment has numerous stakeholders, how does the ELPRO LIBERO Cloud platform gather all the data and help make real-time decisions for quality, efficiency, and service?
BAMERT: The LIBERO Cloud solution, powered by liberoMANAGER, ensures compliance and data security through archival. The platform is scalable to add multiple sites, partners and processes. It enables shipment tracking and management; stability budget assessment and correction of logistical errors; trend-based alarming, automated reporting, missing logger notifications, and more. For complex operations with multiple processes and bespoke API and ERP system integrations, liberoMANAGER unlimited enables automated assessment and notifications, mixed load deliveries, as well as customer workflows and dashboards.
MISHRA: Specifically, how does ELPRO's environmental monitoring systems ensure reliability and compliance through the last mile of delivery?
BAMERT: With over three decades of experience, ELPRO solutions are trusted and proven by the world’s leading pharma, life science, healthcare and logistics companies. Of course, all hardware and software is GAMP 5 validated and 100% compliant. ELPRO provides real value through a variety of monitoring solutions. For example, our LIBERO ITS, (smart electronic indicators) that can be read-out via smartphone and monitors stability budget. It literally stays fixed to the product at kit- or box-level from labeling to last mile. Our local teams of ELPRO experts work to deliver the highest levels cost efficiency throughout the entire spectrum of our customers’ supply chains. In addition, ELPRO facilities adhere to ISO 9001 to ensure the highest quality management and our calibration labs worldwide are ISO 17025 accredited.
MISHRA: What GxP qualification and mapping services do you offer?
BAMERT: ELPRO GxP experts consult with customers to help establish user requirement specifications (URS) for regulatory compliance, which form the basis for validation activities. We also offer assistance in conducting risk assessments; temperature mapping of rooms and warehouses, laboratory equipment, and fleets; and strategies for successful design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of laboratories, fleets, cleanrooms, storage facilities, and equipment.
MISHRA: How does the recent acquisition of ELPRO by the Bosch Group strengthen the company’s value proposition to the life sciences and biotech community?
BAMERT: Being part of the Bosch Group, more specifically of Bosch Service Solutions, complements ELPRO’s monitoring solutions with powerful, worldwide service expertise. Combining the strengths of both companies allows us to offer innovative service models to even better contribute to our customers’ compliance and, hence, patients’ safety. Details will follow as soon as we are ready to release these new offerings to the market. Today there are complexities and risks in the full lifecycle of a pharmaceutical medicine. What we can control are the environmental conditions that can affect the stability of medicines, like temperature and relative humidity. With the right comprehensive data monitoring system to measure critical parameters, pharmaceutical manufacturers can assure patients with hard evidence their medicines have been safely handled throughout the complete supply chain.and calculating stability budgets of
