Tracking the Expansion Activities of Contract Service Providers - Pharmaceutical Technology

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PharmTech Europe

Tracking the Expansion Activities of Contract Service Providers
A review of recent moves of CDMOs and CMOs

Pharmaceutical Technology
pp. s22-s28

Parenteral drug manufacturing and analytical support
Several companies recently expanded their parenteral-drug manufacturing capabilities. In late 2012, AAIPharma Services announced the expansion of its parenteral-drug manufacturing facility in Charleston, South Carolina. The expansion includes the installation of compounding and aseptic processing suites to contain a newly acquired Monoblock vial-filling machine, expansion of a microbiology laboratory, onsite formulation-development capabilities, and enhanced analytical instrumentation. Following the company’s opening of its technology center in May 2012, AAIPharma acquired additional instrumentation to support its analytical and biopharmaceutical development laboratories. It added systems for new inductively coupled plasma-mass spectrometry, gas chromatography-mass spectrometry, liquid chromatography-mass spectrometry, ultra-high-performance liquid chromatography, and high-performance liquid chromatography. The company also expanded its biopharmaceutical development services by adding a micro-flow imaging system, a multi-angle laser light-scattering detector, and a dynamic light-scattering detector to support aggregate and particulate-testing services. A capillary isoelectric focusing system was added to support protein analysis. AAIPharma also expanded its extractable and leachable) testing services.

In 2013, Vetter’s new filling line at the company’s Ravensburg Vetter South facility in Ravensburg, Germany was fully validated for cGMP filling. The line’s capacity ranges from mid- to large-volume batch sizes, with a maximum filling speed of 800 presterilized syringes per minute. The line currently fills 1-mL-standard-format syringes, with additional formats to be added in the near and long terms. Also, its 18,000-ft2 facility, known as Ravensburg Vetter West, which began operations in April 2012, successfully completed an FDA inspection. The site provides high-bay warehousing for cold storage and room-temperature products as well as visual inspection. Additionally, Vetter broadened its portfolio for lyophilized substances by offering its filling service for high-quality sterile water for injection syringes with five years of stability data.

In January 2013, Dalton Pharma Services began the first stage of its aseptic-filling expansion plan. The investment adds high-speed sterile vial-processing and washing capability, an upgraded high-purity water system, vial-depyrogenation capabilities, lyophilization capacity, and automated vial-inspection capabilities. The upgraded GMP sterile-manufacturing capabilities will allow the company to handle larger-volume commercial aseptic filling of sterile liquids and sterile powders. Later stages of the sterile-processing expansion will include additional GMP manufacturing facilities, equipment, and automation to provide integrated sterile manufacturing services from preclinical to commercial production for sterile API and finished doses.


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