High-potency manufacturing continues to be an area of investment for pharmaceutical companies and contract service providers.
Many companies have recently invested or are planning expansions in API manufacturing and finished product manufacturing.
Patricia Van Arnum
Examining the market
The impetus behind this investment has been the growth in the oncology drug market. In 2010, the global market for oncology
drugs was $57.1 billion, according to the IMS Institute for Healthcare Informatics. Market growth was strong; the compound
annual growth rate (CAGR) for oncology drugs was 13.2% between 2006–2010. Although growth is expected to slow, due in part
to generic-drug incursion, the global oncology drug market is still expected to increase at a CAGR of 5–8% through 2015, and
reach between $75 billion and $80 billion, making it the largest single largest therapeutic drug class by value, according
to IMS estimates.
API high-potency manufacturing
To keep pace with market potential, several CMOs recently expanded capabilities for high-potency API manufacturing. In October
2011, SAFC was granted SafeBridge certification for its commercial-scale high-potency facility in Verona, Wisconsin. The SafeBridge
program assessment focuses on four primary areas: management, hazard identification and evaluation, hazard controls and communication,
and education and training. The $30-million facility in Verona opened in 2010 to support Phase III and commercial-scale high-potency
API manufacturing. The SafeBridge assessment also included a successful recertification of SAFC's nearby Madison, Wisconsin,
high-potency manufacturing facility.
In March 2012, the CMO Aesica opened a new $4.6-million high-potency manufacturing facility for formulated products and confirmed
plans to upgrade its API manufacturing facilities to manufacture high-potency APIs at commercial scale. The upgrade will enable
Aesica to manufacture SafeBridge Category III API and formulated products from pilot to commercial scale from two of its sites
in Europe. The new facilities will produce high-potency APIs in quantities of 1– 200 kg. Further investment in 2013 will equip
Aesica to produce batch sizes up to 600 kg.
Lonza invested CHF 24 million ($25 million) to expand its cytotoxic manufacturing capabilities in Visp, Switzerland, by adding
multikilogram-scale cytotoxic production for clinical and commercial production. The expansion, announced in May 2011, was
scheduled to be completed in the second quarter of 2012. The expansion complements the company's high-potency GMP laboratory
suites that operate on a gram scale. In its first-quarter earnings release, the company noted approval for a 250-L high-potency
API expansion in Visp.
Helsinn Advanced Synthesis recently reported on its cytotoxic and high-potency manufacturing facilities in Biasca, Switzerland
and multiyear expansions. Its capabilities include pilot-scale, small-scale, and commercial-scale capabilities for manufacturing
highly potent APIs. It cytotoxic capabilities include isolated and dedicated cytotoxic quality-control and R&D laboratories,
raw-materials and finished-goods warehousing, and finishing and sampling areas. A new laboratory was constructed exclusively
for small-scale cytotoxic production, design of experiment, and initial process development. The company also has pilot-scale,
small-scale, and commercial-scale capabilities for manufacturing cytotoxic small molecules.
Last October, the CMO Saltigo reported it was adding new production capacities for potent APIs at its facility in Redmond,
Washington. The expansion, scheduled for completion in early 2012, allows for production and handling of Category III substances
up to the kilogram range.
Almac is expanding its manufacturing capacity to more than 30 m3 at its European headquarters in Craigavon, United Kingdom to include reactor vessels with product isolation and drying equipment
to allow highly potent API manufacture up to the 600-kg batch size. Almac reported the expansion last October and said the
facility will be built, commissioned, and validated in the next two years.
Carbogen Amcis reported earlier this year that its facility in Bubendorf, Switzerland, which includes the manufacture of high-potency
APIs, successfully completed a FDA GMP audit for several commercial products and a pre-approval inspection for another program.
The audit involved an analysis of all systems, procedures, and processes related to the development, validation, and manufacture
of APIs and highly-potent APIs at the Bubendorf site. The site includes R&D capabilities, analytical laboratories, and development
and manufacturing units for manufacturing Category III and IV compounds. In January 2012, Carbogen Amcis acquired Creapharm
Parenterals, a CDMO specializing in liquid, semisolid, and injectable aseptic dosage forms. The acquisition gives Carbogen
formulation, lyophilization and sterile GMP capabilities for drug products, including highly potent products, for preclinical
and clinical-trial materials.
In 2011, the biopharmaceutical company OPKO Health acquired FineTech Pharmaceutical, an Israeli company focused on manufacturing
high-potency APIs. The acquisition included a facility in Nesher, Israel, for pilot- and commercial-scale production of high-potency