Chao Center for Industrial Pharmacy and Contract Manufacturing, West Lafayette, IN, USA

The Chao Center for Industrial Pharmacy and Contract Manufacturing is based in Purdue Research Park, West Lafayette, Indiana and linked to the Purdue University department of Industrial and Physical Pharmacy and Pharmaceutical Sciences. The facility is one of only five university-affiliated pharmaceutical manufacturing centres in the United States.

The centre required an estimated investment of $8 million to construct. Allen Chao, a Californian Purdue University alumnus, donated the bulk of the investment. Dr Chao, chairman, president and chief executive officer of Watson Pharmaceuticals Inc., and his wife, Lee-Hwa Chao donated a $5 million gift in 2001 towards the construction and outfitting of the12,000ft² pharmaceutical manufacturing and development facility.

Chao earned his PhD in industrial and physical pharmacy from Purdue in 1973. His wife, Lee Hwa-Chao, earned her BSc in pharmacy from Purdue that same year. Chao founded Watson Pharmaceuticals in 1983. The company develops manufactures and markets branded and off-patent niche or generic pharmaceutical products. The Chao Center is a joint project involving Purdue University and Elli Lilly and Co.

The construction of the facility, which was started in 2003, was completed in early 2005.

LEGACY DRUGS AND THE FIGHT WITH TUBERCULOSIS

The cGMP compliant facility will assist with the development and production of legacy drugs, which are drugs for diseases and conditions that affect the underprivileged, especially in third-world countries, as well as less profitable drugs that are made in small volumes for the treatment of certain diseases.

The first drugs to come off the production line are expected to be antibiotics that are effective for treating Multiple-Drug Resistant Tuberculosis (MDR-TB). The combination of drugs needed to eliminate the TB bacteria from a patient’s system are often not available - or when they are available, are not administered in the necessary quantities or for a sufficient period of time. The bacteria can then become resistant to standard treatment, and two specialist antibiotics - capreomycin and cycloserine (seromycin) - are needed to cure it.

More than 400,000 new cases of this form of TB were reported in 100 countries in 2004. The centre's mission includes pharmaceutical education, development and manufacturing and also calls for its participation in the development of the next generation of pharmaceutical manufacturing professionals.

Eli Lilly has generously offered to assist several developing countries fight TB by transferring the specific technology necessary to produce these two drugs and assist in their start-up efforts. Under a partnership with Eli Lilly, the Chao Center will produce the drugs, which Lilly will distribute, and the centre will then assist with training programs to allow developing countries to manufacture these drugs and others using well-founded general manufacturing principles and quality standards through good manufacturing processes.

DESIGN AND CONSTRUCTION

The Allen Chao Center for Industrial Pharmacy and Contract Manufacturing was coordinated and designed by Purdue Architects and Lockwood Greene / CH2MHill. The Engineering, Procurement and Construction (EPC) contract was also awarded to Lockwood Greene/CH2MHill.

The construction was completed in two phases with phase one encompassing conceptual, preliminary and detailed design work. This was followed by phase two EPC and validation. The manufacturing centre design includes 2,000ft² of office space including two conference rooms, 10,000ft² of good manufacturing process space that includes a multi-use analytical and drug-development lab, five multi-use rooms, a drug packaging room, areas for handling materials and for cleaning equipment, a warehouse facility and a viewing corridor that will allow pharmacy students to see the manufacturing process in action.

Under federal regulations, the cGMP areas are required to be completely secure, operate under differential air pressure and be manned by highly trained individuals. Air handlers exchange old air for new 20 times an hour within the manufacturing area, which has nonporous floors that are easily cleanable.

In addition to the new building, the centre also makes use of 6,500ft² of space for pharmaceutical, analytical and formulation development within the Purdue Technology Park.

STAFFING AND STRUCTURE

Student interns will support the efforts of half-a-dozen initial employees. Up to 20 employees will be on staff by the end of 2005. Most of these positions will require a college degree, with the exception of a few technician positions.

In the long-term it is expected that the centre will support approximately 50 high-skills, high-wage careers. Purdue Research Foundation and Elli Lilly Corporation will administer the centre as the largest shareholders in the Chao Center's Limited Liability Corporate (LLC) structure.

SERVICES AND EQUIPMENT

Specific services provided to clients include preformulation, formulation and analytical development; the preparation of regulatory submissions; and the manufacturing of non-sterile pharmaceutical products for clinical trials and commercial products.

Centre services include:

• cGMP manufacturing
• Dosage form preparation and blinding
• Open and blinded clinical packaging and labelling
• Semi-automated over-encapsulation; granulation, tableting, encapsulation and coating
• Schedule II–IV control drug manufacturing
• Analytical services
• Dissolution testing
• Stability testing
• Purity testing
• Impurity identification
• Particle-size determination
• Compatibility testing
• Solubility screening
• Hygroscopicity studies
• Method development and validation
• Chromatography
• Controlled drug substances testing
• Cytotoxic drug substance testing

The centre's drug manufacturing equipment includes:

Tablet press: Manesty Betapress, fully instrumented for ejection and compression monitoring and producing 750 to 1,500 tablets per minute.

Capsule filler: Zanazi 40E, vacuum-assisted powder fill producing 40,000 capsules per hour.

Granulator / coater: Diosna high-shear granulator Model P10-60, bottom drive impeller, side mounted chopper / intensifier with 10L, 25L, and 60L capacities. Fluid Air Model 20 fluid bed processor with a Wurster coater, top and bottom spray and a 45L / 5kg capacity. AccelaCota Compu-Lab with interchangeable fully perforated 12in, 15in, 19in, 24in pans and a 25kg capacity.

Blending: Kinetics Tote System blender with a 1.5ft³ bin.

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