As the primary component of medications that produce the intended result or health effect, the viability of active pharmaceutical ingredients (API) is critical for safe and effective treatment. APIs are highly sensitive, requiring specific environmental conditions as they are easily affected by changes in temperature, humidity, and light exposure, with even slight changes leading to lower potency of APIs or causing them to be unsafe.
Often stored in large quantities known as bulk APIs, this bulk storage offers significant advantages for manufacturers, including consistent quality, supply chain efficiency, and cost-effectiveness. Bulk APIs can be especially beneficial when relying on international suppliers, as global transportation and importation can potentially cause delays in the sourcing of materials.
The drawback of bulk APIs can be needing a GMP-compliant, temperature-controlled facility for storage without causing disruptions to the manufacturing process, but since many organizations either do not have their own space or personnel to manage the storage and logistics of these materials, or they prefer to focus internal teams on other preclinical or clinical activities. Therefore, many choose to outsource the bulk API storage, but how can you identify the right outsourcing partner? Below are factors to keep in mind while searching for bulk API storage.
What are the Storage Conditions for API?
Environmental Conditions
Like most biopharmaceuticals, the necessary storage conditions vary from material to material, but there are prevalent temperature conditions more prevalent than others. While choosing to outsource, it is essential that your storage partner can maintain a suitable environment to prevent degradation. For example, the most common climate conditions include:
- Relative humidity typically should not exceed 60% to 65%
- Controlled Room Temperature (15°C to 25°C) is the standard used for many APIs
- Refrigerated (2°C to 8°C) is used for APIs that are more sensitive to high temperatures, such as some injectables or trial batches
- Frozen (-20°C to -40°C), Ultra-low (-40°C to -80°C), and Cryogenic (down to -170°C) are used for long-term storage
While determining the right biostorage partner, confirm if they offer the right environmental conditions, including any custom conditions required. At SciSafe, we store at all of the above standard environmental conditions within our temperature range from up to +40°C at ambient to as cold as -196°C in liquid nitrogen.
Quality and Compliance
APIs must be stored under strict standards in regularly inspected facilities that have been certified by regulatory agencies to ensure the highest quality is upheld for best preserving the materials. For example, in the United States, the FDA offers industry guidance through their Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regarding Q7 cGMPs which defines the manufacturing of APIs to “include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls.”
When it comes to upholding quality and compliance, SciSafe is CDER-registered in all US facilities, CBER-registered for all NJ facilities, and has undergone 7 FDA inspections with no 483 findings since 2011. In addition to following ICH Q7 and Q9 guidelines across all global facilities, our Netherlands location has an API Registration Certificate through the IGJ.
Beyond Storage
Usually requiring careful handling, containment, and transport, APIs may be incredibly diverse, but their need for robust quality systems, proper Inventory Management Systems, and precise cold chain logistics remains consistent throughout the life sciences industry. Validated processes and equipment for handling and transport, as well as storage, protect their integrity.
With full chain of custody transparency, SciSafe works with all major global courier services as well as provides last-mile pick-up and delivery by our DOT and IATA-trained staff, bolstered by strong contingency plans, decades of experience, and validated backup carriers.
How to Choose Secure Storage for APIs
Safeguarding APIs is crucial for safe and effective treatments, so choosing the right partner to outsource with allows organizations to limit deterioration and potential loss of materials. Due to their uniqueness, APIs may necessitate out-of-the-box customized support. SciSafe specializes in built-to-suit solutions, with over 15 years in operational experience assisting our biopharmaceutical partners through the entire supply chain.
Want to see how SciSafe can assist from preclinical through commercial storage and logistics? Contact us today!