A Strategic Guide for U.S. Pharmaceutical Manufacturers
As more pharmaceutical companies bring drug manufacturing stateside, a critical but often under-planned question arises: what happens to your product after it leaves the manufacturing floor?
For products requiring strict temperature control and regulatory compliance, storage isn’t just about holding space. It’s about protecting product integrity, meeting regulatory expectations, and maintaining agility in your supply chain. Choosing the right storage solution that is scalable to meet the dynamic needs of product pipelines can make the difference between a smooth path to market or costly delays.
The Storage Question: Why It Deserves a Seat at the Table
Pharma teams spend significant time ensuring manufacturing processes are robust, validated, and compliant. But post-manufacturing storage can be overlooked, sometimes until the last minute. That’s a risk.
Key questions every manufacturer should ask early:
- Cryopreserved starting material (e.g. leukapheresis)
- Gene-modifying viral vectors (retroviral & lentiviral)
- QC and reference samples
- Final drug product preparation
If the answer is unclear or inconsistent, it’s time to reassess.
From Ultra-Cold to Controlled Room Temperature (CRT): Know Your Storage Requirements
Different drug products and active pharmaceutical ingredients (APIs) have different storage needs. Understanding these early in the manufacturing lifecycle is essential:
- Ultra-low and cryogenic products (e.g., biologics, mRNA therapies) require highly specialized
-80°C or -196°C LN2 gas phase storage with validated temperature control and expert handling. - Refrigerated and frozen (+5°C to -20°C) products demand scalable storage that can support both clinical trials and commercial distribution.
- All products benefit from environments that maintain cGMP/GDP compliance, proper documentation, and physical and data security.
Aligning these requirements with your long-term storage and distribution strategy helps minimize handoffs, avoid excursions, and maintain chain of custody.
Compliance-Driven Storage for cGMP Pharma Product Integrity
Storage conditions must meet more than operational needs; they must also meet regulatory scrutiny. This includes:
- Documented compliance to Good Manufacturing and Distribution Practices (cGMP/GDP)
- Robust Quality Management Systems (QMS)
- 21 CFR Part 11 compliance for digital records and audit trails
- Chain-of-custody and Cold-Chain tracking to ensure accountability from storage to shipment
- Licensed to handle storage and distribution to intended destinations.
Whether your storage is handled in-house or through a partner, these systems must be in place to protect your data, your product, and your patients.
Eliminating Delays with Agile, Transparent Pharma Materials Storage
The pharmaceutical supply chain demands greater responsiveness and transparency. Storage is no exception.
Manufacturers should look for:
- Real-time inventory visibility to support agile planning
- Fast material turnaround to enable responsive shipping or retesting
- Secure digital systems that make records accessible for internal teams and regulators alike
- Scalable resources that allow for rapid scale up as product needs increase to meet demand
Without these, you risk slowdowns, errors, and inefficiencies that ripple across your timeline.
Pharma Product Storage Isn’t Just a Logistics Decision, It’s a Strategic One
Many manufacturers view storage as an afterthought, just another point in the chain. But for regulated, temperature-sensitive drug products, storage is a critical control point. Your approach to storage affects:
- Time-to-market
- Quality control
- Regulatory success
- Cost-efficiency
Choosing the right partner or infrastructure should reflect these priorities, not just convenience.
Conclusion: Plan U.S. Pharmaceutical Product Storage Like You Plan Manufacturing
Your U.S.-based drug product deserves a storage plan that supports its success. By identifying the storage conditions, compliance needs, and operational priorities early, you can make smarter decisions that protect your product and your timeline.
It’s not just about where your product is kept, it’s about how well it’s protected, tracked, and ready for what comes next. The experts at Azenta Life Sciences specialize in cGMP controlled cold chain storage and management that is scalable to help safeguard the integrity and quality of your indispensable products, all while enabling retrieval of your materials in as fast as 24 hours. From controlled room temperature to our core competency in ultra-cold storage – we maintain secure cold chain logistics every step of the way.
Learn more about how partnering with Azenta from development through commercialization can simplify and improve your U.S. pharma material workflows.