Growing Concerns at Lancaster Laboratories

For the 10th time in its history, Lancaster Laboratories (Lancaster, PA), a pharmaceutical contract manufacturing company (CMO), finds itself in the midst of a physical plant expansion. The new construction will create nearly 50 percent more space for laboratories and offices, which will accommodate 200 additional personnel. The new, 5,000-square-foot building is expected to be completed some time in 1998.

According to J. Wilson Hershey, Lancaster's president, several factors propel the company's continuing growth. "The teamwork of our employees and their can-do attitudes enable us to deliver the high level of quality and service demanded by discerning clients," he says. "Through their efforts, we've built a core of loyal clients, a number of whom have been with us for most of our 36 years."

In the first stage of construction, the top floor of the new building was finished for office space. Moves to this space have freed up 12,000 square feet in the existing building for additional laboratories. "This is a critical need for us," says Carol Hess, executive vice president for administration. " More and more industrial firms and pharmaceutical manufacturers are outsourcing their analytical work to us, and we need space for additional employees and instruments."

Meeting ICH Standards
As part of the expansion, Lancaster's pharmaceutical business unit has already expanded capacity for housing stability samples to meet the current International Conference on Harmonization (ICH) guidelines for stability studies. The group has added a second photos/ability chamber and two new room-size stability chambers that more than triple overall capacity for stability sample storage. A separate limited access building on site now houses 18 stability chambers.

The second photostability chamber greatly increases the group's capacity for performing studies to meet the current ICH photostability guideline. In addition to tripling the photostability sample storage area, the chamber irradiates samples to the required exposure levels in one-third of the time previously required. Independently controlled banks of both UV and Cool White fluorescent bulbs in the chamber allow either concurrent or sequential exposure to the two required sources.

The two new room-size chambers, manufactured by Lab-Line Instruments, Inc., were designed to maintain temperature and humidity conditions in accordance with the ICH guidelines. Like all other stability chambers at the company, the new rooms are connected to an Environment Monitoring System (EMS).

Based on Kaye Instrument's LabWatch system, the EMS continuously monitors and records environmental conditions within the chambers and automatically calls appropriate personnel when any monitoring point falls outside its allowed operating range.

The EMS is also configured to perform continuous mapping of temperature and humidity within the new chambers. Temperature and humidity sensors have been installed in all eight corners of the chambers and at positions every 10 feet horizontally and eight feet vertically, resulting in a combined 84 monitoring points across the two chambers.

Continuous mapping of the chambers allows departmental staff to be notified immediately by the EMS if any repair or change in sample load or configuration has had an adverse effect on the chamber's temperature and humidity distribution.

Other "Growth" Issues
Expanding a company's physical plant is one thing; increasing business is quite another. In a recent interview with Pharmaceutical Online, Wesley Neumann, Lancaster's Director of Pharmaceutical Sciences, described the business climate at Lancaster and the CMO industry at large.

Neumann said that yes, everything we read about the growth of pharmaceutical outsourcing is true. More major drug firms are indeed turning to more contractors. But outsourcing is no longer limited to industry giants looking for incremental manufacturing capacity.

"Some of the firms we do business with," Neumann stated, "can be described basically as six guys, six desks, and six computers." Neumann was referring, of course, to "virtual" pharmaceutical companies where significant science or business activity is farmed out. Neumann says he's seen "some of the best, most innovative ideas" come from such micro-corporations.

According to Neumann, outsourcing has evolved into an exciting but highly pressurized business characterized by "time crunches, stress," and an obsession with time-to-market.

Neumann ascribed the recent report of CMOs offering widely different cost estimates for the same job to a lack of communication between contractors and clients. "You'd be surprised at how many drug companies don't understand outsourcing," he said. Neumann thinks too many companies think of CMOs as simple extensions of their own science and development laboratories, sometimes expecting better, faster, less expensive results from contractors than they obtain from divisions of their own companies. "Getting a fair, accurate price estimate to clients involves asking a lot of questions, which we like to do, but we're not always talking to people who have the answers." Another factor which clients overlook is regulations and associated cost factors. "Our customers always know what they want to pay for a job," Neumann said, "but they don't always understand the relevant regulations that cost money to follow."

For more information: Wesley Neumann, Director, Pharmaceutical Sciences, Lancaster Laboratories, 2425 New Holland Pike, PO Box 12425, Lancaster, PA 17605-2425. Tel: 717-656-2308, ext. 1514.

By Angelo DePalma