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GEN News Highlights : Jan 14, 2014

AAIPharma Finishes Expanding Parenteral Manufacturing Facility

AAIPharma Services just finished a multimillion dollar expansion of its cGMP parenteral manufacturing facility in Charleston, SC. The contract services firm says the three new suites that have been added will be fully operational by February.

The three suites, according to the company, were built and designed by AES Clean Technology and are equipped with the following:

  • A Chase-Logeman monoblock FSAS
  • A Lytzen ISO Class 5 depyrogenation oven
  • A BMT Steripro cGMP steam sterilizer
  • A SP Hull pilot-scale lyophilizer with a complementing production-scale lyophilizer on order

AAIPharma believes the expansions will double the facility’s sterile product development and production capacity. The production-scale lyophilizer in particular, the firm says, will more than triple the facility’s lyophilization capacity by the end of 2014.

James Fife, senior director of parenteral operations, listed low line loss and in-line weight check capabilities among the new features of the expansion and added, "In the coming months, the pilot and production-scale SP Hull lyophilizers will be brought online, affording seamless lyophilization cycle optimization and scale-up."

In October, AAIPharma announced a merger with chemistry outsourcing company Cambridge Major Laboratories. The two firms said they ultimately aim to form a premier global supplier of integrated CMC services including process chemistry, solid-state chemistry, API manufacturing, and formulation development.