Tracking the Expansion Activities of Contract Service Providers - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
28%
Oversee medical treatment of patients in the US.
10%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
8%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
Source: Pharmaceutical Technology,
Click here