WILMINGTON, North Carolina, June 20, 2016 /PRNewswire/ -- Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces it has taken major steps in upgrading its laboratory service capabilities to meet market and client demands. Approximately 5,000 square feet of the current Technology Center located in Wilmington, NC will be converted to newly reconstructed laboratory space.
The newly reconstructed laboratory space will be dedicated to dissolution testing (Apparatus I, II, III, IV and intrinsic dissolution), Karl Fischer testing (humidity controlled room), microbiology, and formulations development. The new space adds 15% additional capacity for dissolution as well as a new capability of a UV sampling automation. Further laboratory expansion is expected with construction of a new building, which was announced in Nov 2015. The new building will provide increased capacity and flexibility to meet client needs. Efficiency efforts following Lean Six Sigma 5S and Lean principles will be paired with this physical expansion. One of five laboratory spaces has already completed redesign/process flow optimization and the remaining labs will be completed by end of 2016.
Beyond facility changes, Alcami also continues to invest in equipment and personnel. Since January 2015, its development teams have grown by 10%. $1.6M has been invested in state of the art equipment such as:
- Dionex Ion Chromatography instrumentation – Increasing capacity for ion chromatography testing by 25%
- In-line UV automation for dissolution testing for improved quality and efficiency
- Agilent 7900 ICP-MS – Increasing capacity by 50%; plans to add units in Edison and St. Louis over the next 12 months
- Coulochem Detector for ion chromatography, which is a new capability
- Specialty detectors (Refractive Index detector, Evaporative Light Scattering Detector, and Charged Aerosal Detector) added to Wilmington and Durham sites for increased capacity
- MicroSEQ® library and an Applied Biosystems/Hitachi 3500 Genetic Analyzer capable of successfully identifying microorganisms to the species level. The system is ideal for environmental monitoring, contamination investigation, root cause analysis and raw material testing.
The company has also improved its stability services by adding 2,000 cubic feet of chamber space, new control systems for all chambers, and a state of the art REES monitoring system to maintain the safety and integrity of all its clients' stability samples at all times.
Alcami is on the forefront, responding quickly to regulatory changes such as the new guidelines for abuse deterrent studies and elemental impurity testing. Its expertise continues in performing API / standard characterization studies, intrinsic dissolution evaluations, semi-solid comparator studies, filter validation to support parenteral drug manufacture and studies to support the microbiological quality of drug products after penetration of the container system for dose preparation prior to patient administration.
Alcami also recently announced Saturday sample delivery for its clients across all of its laboratory locations. This ensures utilization of precious time without concern regarding sample storage or handling. The sales and project management teams will help demonstrate the significant impact that this change can have on the critical deadlines of its client projects.
Alcami is committed to ongoing investment in its people, technology, capabilities and equipment to allow Alcami to better meet all of its clients' needs – from clinical to commercial.
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.