Life Sciences Tools and Services
Company Overview of AAIPharma Services Corp.
AAIPharma Services Corp. provides pharmaceutical development, analytical, and manufacturing services in the United States and Europe. Its pharmaceutical development services include early phase clinical trial material formulation development, analytical method development and validation, biopharmaceutical analytical development and validation, clinical trial material manufacturing, oral solid dose manufacturing, sterile/aseptically processed manufacturing, stability storage and testing, regulatory affairs support, and project management; and packaging, labeling, and distribution. The company’s analytical services comprise analytical testing, biopharmaceutical services, elemental impurities, ...
2320 Scientific Park Drive
Wilmington, NC 28405
Founded in 1979
Key Executives for AAIPharma Services Corp.
Vice President of Legal and Contract Affairs
Compensation as of Fiscal Year 2016.
AAIPharma Services Corp. Key Developments
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. Expand IDBS' E-WorkBook Platform Across Global Analytical Sites
Mar 8 16
AAIPharma Services Corp. Cambridge Major Laboratories, Inc. has expanded its IDBS E-WorkBook platform across analytical laboratories in the United States and will be incorporating its Netherlands facility in the coming months, to support further company growth. The expansion complements all six of AAI/CML's US sites which have been using E-WorkBook for three years, moving away from paper-based processes to streamline sample analysis and encourage collaboration. E-WorkBook enables AAI/CML to record and share data from its API custom development, testing and manufacturing, analytical development and testing and drug product development, testing and manufacturing teams, on a single platform across the company's seven sites. This approach saves time, boosts productivity, streamlines the review process and ensures quick access to data for compliance purposes. Laboratory analysts across the company use a number of validated templates to ensure standardized data input, reducing errors often associated with transcribing paper-based results. When the company was recently audited by the FDA, it was able to easily provide a full audit trail, which is essential in such a highly-regulated industry.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. to Invest $10.7 Million in New Facility at Cortex Innovation Center in St. Louis, Mo
Feb 18 16
AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML) announced the planned investment of at least $10.7 million to relocate its St. Louis, MO analytical testing facility to the Cortex Innovation Center. AAI/CML provides innovative analytical testing solutions for manufacturers' new drug entities, generic drugs, animal health products, medicated consumer health products, chemicals and biopharmaceuticals. Its analytical testing business is comprised of three centers of excellence in St. Louis, MO; Wilmington, NC; and Edison, NJ to serve its regional, national and global customers. Its current St. Louis, MO facility employs approximately 80 full time staff and specializes in chemical and microbiological analytical testing including raw material testing, drug product release, stability, and environmental monitoring for both sterile and non-sterile drugs. The new facility is a response to increased customer demand and the growing trend of analytical testing outsourcing within the pharmaceutical and biotechnology industries. It will house equipment in addition to its existing service offerings, and will provide new testing capabilities to meet industry and changing regulatory requirements, such as glass and plastic containers testing for pharmaceutical use, elemental impurities, disinfectant qualification and efficacy studies. The structural completion and build-out are due to be finished in the fourth quarter of 2016 and transition from the existing location will occur in the first quarter of 2017. The new facility will be operational concurrently to ensure no interruption of customer commitments in testing during the transition period until the new site is fully operational. AAI/CML's additional sites in Edison, NJ and Wilmington, NC will serve as testing support if appropriate. Each existing project will be discussed in detail with customers to ensure a seamless transition. Stability chambers at the new facility will be operational prior to removing this capability from the existing site so as not to interrupt any studies. Transfer of stability samples to the new facility will occur using temperature controlled equipment and will be monitored to ensure no deviations from specified conditions. The two facilities are within close proximity, with a travel time of less than 30 minutes from each other. Clients will be notified prior to shipment of stability samples. The new facility will have a new FDA registration number and clients will be notified in advance when their studies are planned to be relocated. AAI/CML will absorb the cost of method transfer exercises, re-verifications or method suitabilities related to the site move, ensuring relevant regulatory requirements continue to be met.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. Announce ProForm Select™ Integrated Offering for Solid State Chemistry and Formulation Development
Feb 4 16
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. announced an integrated service offering for solid state chemistry and formulation development to help the pharma/biotech industry meet important milestones and maintain stability in drug development. ProForm Select™ aligns its solid-state, process chemistry and formulation development centers of excellence in Weert, The Netherlands, Germantown, Wisconsin and Wilmington, North Carolina.
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