2 min read
Stability programs provide vital information required for regulatory approval, and the data produced is critical to the success of your drug product approval. In-house storage can be hindered by limited capacity, putting your critical samples at risk where no redundancy exists, or backup power is limited to a single source.
What you need is not a storage provider that simply houses your product, you need a team that is relentlessly focused on your product and deliverables. When you team up with us, you’re provided with confidence in handling, storage, tracking, maintenance, delivery of your samples, and support, every step of the way.
Alcami, is an industry-leading storage solution provider that biopharma companies have relied on since 2009. Read on to learn about the Alcami Advantage.
Modern Capacity, Multiple Conditions, Flexible Solutions.
Being a storage solution partner means supporting diverse capacity requirements consisting of multiple studies and lots. When we say “Store a Lot” we mean a lot. We recently added a brand-new, state-of-the-art stability suite to ensure your capacity needs are met and expectations exceeded. Whether you need long-term, accelerated, retain, thermal cycling, ramping, or custom needs, we have the infrastructure and expertise to support your critical projects.
While walking through our facilities, eyes are drawn to the wide range of state-of-the-art reach-in and walk-in stability chambers, each equipped with continuous monitoring with around-the-clock visibility.
Product security is ensured through strict security access control programs with 24/7 security camera surveillance and multiple levels of redundancy to ensure your products remain safe. Our new Stability expansion will quadruple our current available capacity and offer mechanical and electrical redundancies to provide the greatest level of product safety a Stability Chamber can provide.
A Team Relentlessly Focused on Your Products.
Our dedicated client services team is ready to support your needs along the way, while our Operations team provides the hands-on expertise during your pulls. Your samples will be safe in the hands of our trained storage experts and support teams who monitor our chambers 24/7.
Clients local to the New England region have access to our Alcami Courier service. Alcami maintains a fleet of vans and validated trucks, providing you with ambient, refrigerated, and frozen transportation options to supplement third-party carriers.
The final element of a robust storage solution partner is a deep understanding of its responsibility with your product and beyond. We understand the importance of your product and the level of care it requires and deserves.
When you choose Alcami to be your storage solution partner, you are not storing with a warehouse. You are storing with the industry leader who understands the important role and impact that stability and storage programs have. That is the Alcami Advantage.
- QMS system compliant with ISO17025 and ISO9001
- Validated IMS with pull scheduling and reporting capabilities
- 21CFR11 compliant software and systems
- Full life cycle traceability
- Space capacity at primary ICH Conditions, with customization available
- State-of-the-art chambers and monitoring equipment
- 24/7 monitoring and on-call response
- Multiple redundancies including high-capacity emergency generators and on-site bulk-storage LN2
- In-house support for Quality, Validation, Metrology, and HVACR
- Department of Transportation (DOT) and International Air Transport Association (IATA) shipping capabilities
5 min read
Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to a drug or biological product (drug) to treat a...
3 min read
Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical...