Norwich also added a new "Bosch GKF 1400 L" commercial-scale encapsulation machine (Bosch Group, Stuggart, Germany, http://www.bosch.com/) for filling liquids or semisolids into hard-shell capsules. It also added a low-humidity (17-20% humidity) manufacturing suite.

Bayer Pharmaceutical Manufacturing Services (Shawnee, KS, http://www.bayerpharmamfgservices.com/) plans to bring on-line a new high-speed electronic tablet and capsule counter ("IMA Nova Conta C200," IMA Nova, Leominster, MA, http://www.imanova.com/) at its facility in Shawnee, Kansas. Manufacturing and testing of the filler is currently ongoing, and the filler should be installed on-line by July 2006. This filler will complement other process and packaging equipment, including sterile liquids manufacturing, housed in Bayer's central campus in which the company has invested more than $150 million since 1996.

Mikart (Atlanta, GA, http://www.mikart.com/) recently added a new blister packaging line as part of its solid-dosage capabilities, notes Blair Jones, vice-president of sales and marketing. The new line allows the company to offer coldformed and thermoformed blistering for its customers' products.

"In solid-dosage manufacturing, we see two key trends," explains Colin Minchom, Patheon's vice-president of pharmaceutical development services, Canada. "One is toward lower dose, high-potency formulations, and the second is demand for formulations for poorly soluble drugs. Our addition of capabilities for high-potency actives and liquid-fill hard capsules address both of these needs."

Patheon is investing $7 million to add high-potency manufacturing capabilities (solid-dosage product forms) at its facilities in Bourgoin-Jallieu, France. The expansion is underway and is expected to be completed by the end of 2007.

Patheon is evaluating adding clinical packaging capabilities (primarily for solid-dosage forms) at its sites in Canada and Puerto Rico. It further is evaluating establishing a pharmaceutical development services center for all dosage-product forms in India.

Part of Patheon's manufacturing strategy includes increasing capacity utilization for its Puerto Rican facilities, which it is addressing in part by adding capabilities for high-potency formulations and liquid-fill capabilities. It also is validating these sites to augment existing capacities in Canada and as second supply sites for products from its Toronto-based facilities.

High-potency actives on the rise

Other producers point to opportunities in specialized formulations. "The biggest single recent trend in outsourcing solid-dosage processing has been the movement toward discovery and synthesis of more potent APIs," says Michael Valazza, vice-president of business development, oral technologies for the Pharmaceutical Technologies & Services business at Cardinal Health.

"As recently as two or three years ago, most potent oral solids being presented to us for consideration were cytotoxic," says Valazza. "Since that time, we have seen a significant rise in the number of noncytotoxic compounds with occupational exposure limits of less than 10 mcg/m³ to the point where more than a third of the oral solid-dosage processing opportunities that we have considered in 2006 are potent," he says.

In February, Cardinal's Pharmaceutical Center in Somerset, New Jersey began operations in a newly expanded pilot-plant that is capable of handling potent oral solid compounds in batch sizes as large as 75 kg.