How to Ensure the Integrity of Life Sciences Supply Chains

According to an SAP survey from 2022, a majority of senior executives at enterprise businesses reported that the unprecedented supply chain disruptions caused in large part by the COVID-19 epidemic are still ongoing and that, consequently, their supply chains need significant improvements. During the last five years, it has become evident that in order to overcome these supply chain challenges, companies must leverage advanced technologies, including the Internet of Things (IoT), artificial intelligence (AI), and machine learning (ML).

The growing acceptance of digitalization and prescriptive analytics demonstrates that business leaders recognize their critical role in optimizing inventory management and ensuring asset safety and quality. In fact, the global market value of IoT in Supply Chain Management (SCM) is predicted to reach $41.8 billion by 2033.

The pressing decision for the C-suite, therefore, is not whether to adopt IoT-enabled tools, but how to find and hire third-party vendors to effectively integrate them with their company’s existing asset and inventory management systems at scale. The ultimate goal of this technological investment is supply chain integrity: the process of ensuring that assets are safe and effective along their journeys from procurement of raw materials to delivery and administration.

Supply chain integrity is particularly important for the life sciences industries. For example, without proper oversight of the chain, an entire clinical trial can be jeopardized, leading to wasted resources and delays in the development of new treatments.

What makes a life sciences supply chain unique?

A life sciences supply chain is the complete network of processes, partners, and products involved in producing and delivering health-related products through multiple stages: research and development, manufacturing, distribution, and administration. The primary goal of supply chain management is to protect product integrity and ensure patient safety.

Life science consignments cover a wide range of items, including pharmaceuticals, vaccines, biologics, and blood samples, each with unique requirements for storage, handling, and transportation. The life sciences supply chain is unique due to logistical complexity, GxP compliance, product sensitivity, and high stakes related to public health and business success.

Logistical complexity: connecting partners and processes

The life sciences supply chain is a multifaceted, interconnected web of interdependent systems and suppliers. Disruptions at one link can ripple through the entire chain, thereby increasing the risk of cascading breakdowns. Critical aspects that make life sciences supply chains complex include:

• Multiple partners, including research institutions, contract research organizations (CROs), raw material suppliers, manufacturers, contract manufacturing organizations (CMOs), distributors, healthcare providers, and patients
• Extreme sensitivity of products to environmental conditions requiring real-time monitoring
• Global operations crossing borders with different regulatory frameworks
• Inherent risks from potential delivery delays
• Dynamic and unpredictable demand
  
  

GxP compliance: meeting and exceeding standards for safety and quality

A life sciences supply chain must comply with rigorous quality and safety standards. GxP compliance comprises multi-jurisdictional regulations and guidelines governing different facets of the life sciences industry, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and the 21 CFR Code of Federal Regulations. GxP compliance is crucial for life sciences enterprises to maintain the highest standards for operational efficiency, product efficacy, and patient health.

Enacted in 2013, the Drug Supply Chain Security Act (DSCSA) is a U.S. federal law establishing a single standard for tracking and tracing prescription drugs. Its goal is to enhance security and protect patient safety within a visible and traceable supply chain. Only authorized trading partners (ATP) can conduct business along the chain, and each ATP must have a process to quarantine and investigate irregular life sciences products. If a product is confirmed to be compromised, ATPs must notify the FDA and other affected ATPs.

Product sensitivity: monitoring environmental conditions

Life sciences products are highly sensitive to changes in environmental conditions, thus necessitating specialized handling, storage, and transportation guidelines within narrow parameters to prevent spoilage, degradation, and loss of potency.

• Temperature control: Depending on brand and function, vaccines must be stored within one of three temperature ranges: refrigerated (2°C to 8°C), deep frozen (-20°C to -80°C) and cryogenic (below -150°C).
• Humidity control: High humidity can cause medications to absorb moisture, creating an environment for microbial growth, while low humidity can cause medicines to dry out, compromising their quality. 
• Light protection: Photosensitive antibiotics and antipsychotics must be shielded from light to prevent decomposition.
• Physical handling: Biologics whose complex molecules can be damaged by physical stress are sensitive to shock and vibration during transportation.
• Time sensitivity: Therapeutic agents with short shelf lives must reach patients within tight timeframes.
  
  

High stakes: minimizing risks that threaten patient care

Supply chain disruptions erode patient trust that their healthcare providers have access to reliable and safe life sciences products when they need them. Any disruption in the supply chain can have serious consequences affecting patient care — and business goals.

• Product shortages: Inefficient supply chains cause delays in patient treatment and shortages of critical medications, especially during demand surges, such as flu season.
• Compromised product quality: Failures in cold chain logistics for condition-sensitive products can render medical products ineffective or hazardous.
• Lack of traceability: An invisible or fractured supply chain makes it difficult to trace a product from manufacturer to patient, allowing dangerous goods to go undetected and hindering the rapid recall of compromised products.
• Non-compliance: Failure to meet GxP standards and regulations carries severe risks, including legal penalties, financial losses, and damage to a company's reputation.
  
  

What are first-class credentials for a life sciences supply chain vendor?

For a life sciences enterprise to build a sophisticated IoT solution on its own would require enormous investments to create new infrastructure, hire staff with specialized expertise, and support the program with regular updates to meet shifting regulatory standards and emerging technological innovation. Thankfully, third-party vendors offer robust IoT solutions that assume the burden of implementation and support to meet each life science company’s business needs and goals at proper scale.

When choosing an IoT Sensing-as-a-Service vendor for a life sciences supply chain, consider these qualifications:

• Prioritize vendors with deep industry experience in GxP-compliant environments, robust security practices, scalable and open-platform solutions, and a roadmap for innovation.
• Evaluate their track record for data integration, prescriptive analytics, and technical expertise in AI, ML, and cloud planforms to ensure compliance and improve operations.
• Confirm the vendor provides a comprehensive service, including sensor implementation, ease of deployment to avoid costly infrastructure disruption, and strategic consulting.
  
  

SmartSense has the proven capabilities needed by an IoT vendor to ensure the integrity of life sciences supply chains. Our Sensing-as-a-Service solutions align with critical GxP requirements for life sciences supply chain integrity, security, and quality.

SmartSense solutions support the entire cold chain. The system employs continuous monitoring and delivers instant alerts via multiple channels whenever environmental excursions occur. Beyond alerts, the platform provides prescriptive guidance to help staff take appropriate corrective actions in real time.

As a foundational requirement for regulated customers, SmartSense has achieved SOC 2 Type II compliance. The system securely captures, timestamps, and stores environmental readings to create complete records for audits and inspections. Our solutions also provide National Institute of Standards and Technology (NIST) calibrated probes for temperature and humidity, along with a documented, easy recalibration process.

Learn more about SmartSense life sciences solution to maintain the integrity of life sciences supply chains.