High-Potency Manufacturing Remains Strong - Pharmaceutical Technology

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PharmTech Europe

High-Potency Manufacturing Remains Strong
Companies roll out expansions in manufacturing high-potency APIs and finished products.


Pharmaceutical Technology
Volume 36, Issue 7, pp. 70-72

Finished product manufacturing

Companies also are investing in finished product manufacturing In September 2011, Roche opened a new 17,000-ft2 clinical-supply manufacturing facility at its campus in Nutley, New Jersey, for producing dosage forms of highly potent compounds for preclinical safety studies and Phase I and II clinical studies. The clinical dosage forms produced at the facility include tablets, capsules, powders, suspensions, and solutions. The facility has warehouses for components, excipients, APIs, mechanical rooms, and multipurpose isolation suites for manufacturing.

In November 2011, Metrics began offering neat API capsule-filling at its potent and cytotoxic facility in Greenville, North Carolina. The company secured a Capsugel Xcelodose system, a powder microdoser and automated encapsulator that places API directly into capsules with a high level of accuracy. Metrics also installed a custom-built isolation system for the equipment. The company offers dedicated and segregated potent and cytotoxic cGMP manufacturing for Phase I–III projects. It opened a new potent and cytotoxic drug-development facility in 2009 as part of an expansion of the company's Greenville facility.

Earlier this year, Baxter reported that its high-potency manufacturing facilities in Halle and Bielefeld, Germany, received SafeBridge certification. The facilities in Halle and Bielefeld support Baxter's BioPharma Solutions business, a CMO providing contract sterile manufacturing. In November 2011, Baxter's BioPharma Solutions business completed a capacity expansion at the company's cytotoxic contract manufacturing facility in Halle/Westfalen, Germany. The primary component of the expansion was the modular installation of an additional large-scale, commercial lyophilization unit for increasing freeze-drying capacity to support commercial cytotoxic manufacturing capacity. The expansion followed expansions for cytotoxic manufacturing capacity in 2010 and 2006.

The CDMO Pharmaceutics International Inc. began construction of a new 24,000-ft2 cGMP aseptic fill–finish manufacturing facility earlier this year. Targeted for completion in the fourth quarter 2012, the new facility will more than double the company's current sterile GMP manufacture capacity. Fill–finish suites will include automated vial and syringe filling, inspection and labeling equipment capable of producing batch sizes of 100,000-plus units. The additional facilities will enable the company to provide preclinical through commercial-scale production and meet the growing demand for fill–finish services for potent compounds and oncology drugs.

The CDMO Penn Pharma is investing €14 million ($22 million) to expand high-potency manufacturing at its facilities in South Wales, United Kingdom by adding a new 15,000-ft2 development and commercial manufacturing unit for tablets and capsules. The new production facility is expected to be validated and running by the end of the first quarter 2013.

Pfizer CentreSource has various technologies and capabilities for high-containment oral solid manufacturing, which includes its production facility in Freiburg, Germany. The Freiburg facility was recognized by the International Society for Pharmaceutical Engineers with the 2011 Facility of the Year Award for Sustainability for its Strategic Plant Restructuring and Energy Master Plan project. The Facility of the Years Award recognizes pharmaceutical manufacturing projects that use innovative technologies to enhance quality and reduce costs. The Freiburg facility was recognized for its technologies and automation as part of a sustainability program. Some highlights include a fully automated material-flow system, multipurpose automation systems, paperless order documentation, computer-integrated manufacturing systems, a wood-pellet boiler system for powering air-conditioning systems, and other manufacturing and energy-efficiency practices.

Patricia Van Arnum is executive editor of Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,
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