For decades, pharma supply chains have been dominated by the sale of small molecules. Although there are strict regulatory compliance requirements to grapple with, small molecules can often be stored at room temperature, which has been relatively straightforward and doable with existing storage systems.

The exponential growth of biologics poses a challenge for warehouse, logistics, and supply chain managers because pharma manufacturers and distributors will need to reevaluate their cold chain storage not just for biologics but also for scale.

Meeting GxP compliance and managing the risks of chemical and physical instability in biologics is just as possible as it is in small molecules. The issue is finding the gap in your current processes while managing the complexity of these products.

In this post, we’ll talk through some initial tips for a temperature controlled storage gap analysis for facilities entering or growing their involvement with biologics.

Tips for a Biologics-Focused Cold Chain Storage Gap Analysis

As you know, manufacturers of time and temperature sensitive (cold chain) products have a direct responsibility for maintaining product integrity from the start of production until customer handover.

Although there’s much talk about the move to supporting a great inventory of biologics, most biologic drugs only require standard refrigeration between 2 to 8 degrees Celsius. Only rarely, such in the case of transporting live tissue, is deep freezing (below -15 degrees Celsius) required. So, there’s a need for updated risk assessments. However, you might not necessarily need monumental changes in SOPs and equipment.

A cold chain storage gap analysis identifies areas for improvement and continued compliance within your storage facilities. Whether for your own facilities or in conjunction with your distribution partners and carriers, it takes you one step closer to continuing to operate a fully-compliant cold chain.

Working with your Good Manufacturing Practice or Good Distribution Practice expert on a cold chain gap analysis can help set you up to meet requirements and prepare solutions for the expanded transport and storage of cold chain stock.

Here are a few places to start:

1. Review current SOPs & documentation for time and temperature sensitive goods

Although the greatest risks to product integrity previously largely appeared as the product entered the last mile phase, temperature excursions can appear at any given point in the pharma and biotech supply chain. This is particularly true for complex pharmaceuticals, like biologics.

Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) already require the development of standards and operation procedures for pharma and biotech facilities. However, it can be difficult to compare the often high-level regulations against the realities of biologics because as living materials, they vary greatly. Additional challenges come with new attempts to address manufacturing challenges through continuous manufacturing.

A few key areas to review for manufacturers and wholesalers updating cold chain SOPs to prepare for biologics include:

• Receiving and verification of products
• Methods for storing and holding materials
• Cleaning and maintenance of storage areas and equipment
• Labelling policies (especially temp sensitive)
• Environmental controls and monitoring
• Inventory control
• Management of all environmental condition excursions
• Management of damaged, quarantined, and returned stock

2. Review & update the temperature & humidity map of the warehouse and storage areas

All temperature-controlled storage areas must already be temperature and humidity-mapped (or thermal mapped). However, regular audits are beneficial, whether for the warehouse or a controlled environment.

The temperature map helps you understand whether your equipment is suitable for the environment meeting documentation requirements for most regulators.

If your facility is moving into biologics and you haven’t already transitioned away from chart recorders and handwritten temperature logs, it’s time to consider working with a device-driven temperature and humidity mapping solution. This is particularly true if you’re operating a warehouse. Because while the principles for mapping remain the same, warehouses pose unique challenges as a result of their size and seasonal variations.

Biologics and other advancements are far more temperature sensitive than small molecules. By using a combination of sensors and data loggers for a more real-time and streamlined look at your facility, you’ll be better able to maintain compliance and protect the quality and integrity of these products.

3. Evaluate current climate controlled storage equipment & monitoring solutions

Temperature control for cold chain has never meant preventing extreme temperature swings. It means maintaining a consistent temperature and moisture environment to avoid excursions of any kind and keep continuous records.

There are already ground-breaking developments coming online for drug substance freezing and storage, including solid-state systems. What’s more, scientists are working on ways to get around these intense storage requirements already.

However, for the vast majority of new drugs, this means maintaining a temperature of between 2 and 8 degrees Celsius.

Safety Storage Systems offers temperature controlled units that include:

• Heating only
• Cooling only
• Full temperature control (heating & cooling)

Temperature monitoring for accurate record keeping comes standard as a feature across all models. Segregated temperature controlled storage units are also standard and options can be custom built for your unique environment and use case.

To learn more, request our Temperature Controlled Chemical IBC Store case study or get in touch with our team of experts to discuss your project.