Reliable Cold Chain Solutions: Protecting Product Integrity from Fill to Patient

Introduction

Maintaining the optimal temperature for APIs (active pharmaceutical ingredients) and sterile fill-finish drug products is key to ensuring quality and patient safety. With the growing popularity of biologics, cold chain solutions are in high demand. At JHS, we’ve expanded our refrigeration, freezer, and ultra-cold storage capacity by thousands of square feet to meet your growing needs for validated, monitored space for your APIs or finished drug products.  

Why Cold Chain Solutions Matter

Many biologics, including vaccines, mRNA products, and monoclonal antibodies, as well as oncology drugs, require continuous cold storage to preserve their efficacy. To establish if a drug needs cold storage, technical teams will conduct a stability study. Stability studies provide key information about shelf life, sensitivity to light and humidity, and what temperature range the drug product must stay at 

Reliable cold chain solutions are also critical for storing temperature-sensitive APIs prior to the fill-finish process. Warmer temperatures can trigger unwanted chemical reactions that can degrade the quality of certain APIs.  

Cold Storage Temperature Guide  

Lyophilized or “freeze-dried” products can often remain at room temperature for months, sometimes even years before reconstitution. However, some sterile fill-finish drugs cannot be lyophilized and need to stay in liquid form in cold storage. Some complex, protein-based formulations and liquid antibiotic suspensions may not be suitable for lyophilization and require cold chain storage.  

 How Continuous Monitoring Protects Your Product Integrity

To ensure the fill-finish drug products or APIs stay cold, continuous environmental monitoring sensors track the temperature and humidity of the warehouse space in real time and record the data. The FDA and USP both require temperature monitoring of all pharma cold storage. Since even a short exposure to warmer temperatures could potentially destroy medication, having backup power and alternate cooling sources helps protect the products inside the warehouse in case of an emergency.   

 Partner with Us for Reliable Cold Chain Solutions

As part of our Line 4 expansion project, JHS has added multiple storage options tailored to your product’s unique profile, including new refrigerated, freezer, and ultra-cold storage space.   

  Our Cold Storage Features: 

• Access to our automated building system and backup generators to maintain an uninterrupted power supply 

• Redundant compressors and evaporators to safeguard your product’s integrity 

• Continuous environmental monitoring and recording with AVERA PI software  

• 21 CFR Part 11 compliance to protect your environmental monitoring data 

  Expanded Cold Chain Capacity Coming Early 2026 

 Does your fill-finish project need cold or ultra-cold storage? Our validated cold storage warehouse space ensures your drug product remains safe, stable, and effective until it reaches the patient. Contact us to start a conversation about our expanded cold storage solutions, high-speed fill-finish lines, and available capacity to meet the needs of your unique project.