WILMINGTON, N.C., Sept. 22, 2016 /PRNewswire/ -- Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces strengthened capabilities in analytical services at its Edison, New Jersey site.
Alcami's laboratories in Edison offer comprehensive chemistry, environmental and microbial capabilities to support the development, manufacture and release of medicines and consumer products. The Edison site is the only contract testing operation in the state of New Jersey capable of meeting FDA requirements for Antibiotic Analysis both using USP < 81 > and helping clients develop, validate, and perform bridging analysis to an alternative method per USP < 1223.1 >. The company has also added 2,000 cubic feet of stability chamber space across the network, new control systems for all chambers, and a state of the art REES environmental monitoring system to maintain the safety and integrity of its clients' stability samples at all times, with 770 cubic feet of space in Edison.
Furthermore, the Edison team has a broad range of expertise in multi-compendial testing and customized analysis, such as:
- Antibiotic Analysis
- Disinfectant Efficacy Testing
- Cleaning Validations
- API and Excipient Testing
- Finished Product Release Testing
- Water Testing
- Microbial Assays
- Packaging Component Testing
- Sterility Testing
- Method Validation and Optimization
- Medical Device Testing
Beyond facility upgrades, Alcami continues to invest in people, equipment, and processes. In 2016, approximately $500,000 has been invested in upgrades in Edison. An increasing number of clients are benefiting from Alcami's Saturday sample delivery program across all of its laboratory locations which conserves precious time in receiving samples without adding risks. Additionally, Alcami is transforming its laboratories to drive industry leading operational performance based on Lean principles. The company will complete this process in 2017.
The Edison, NJ site successfully completed a FDA General Inspection in September 2016. The company is committed to its customers and to the highest quality and regulatory compliance.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. have joined to form Alcami, a world class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services.
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