Specialization Key to Contract Manufacturing Success
By Angelo DePalma
With the explosion in contract pharmaceutical manufacturing, one might well ask if it is better to specialize in a particular group of products or to be a jack-of-all trades. Phillip Chalabi, sales and marketing manager for ChemSyn Laboratories, Inc. (Lenexa, KS), thinks the answer depends on the company's size.
New Plant, New Business
ChemSyn, a division of Eagle-Picher Technologies, LLC (Cincinnati, OH) with 60 employees, is building a new, 8,000 square foot facility for manufacturing proprietary cancer drugs for major pharmaceutical companies. "We specialize in high-value, low-volume products, which is almost synonymous with anticancer drugs," Chalabi told Pharmaceutical Online. "Whereas drugs for most other therapeutic categories require annual production measured in metric tons, the types of compounds we work on run in the tens or hundreds of kilograms per year. These are specialty pharmaceuticals which are very difficult to make."
Chemsyn's cGMP production facility
And very difficult to handle safely in a manufacturing environment, which is why ChemSyn is building the new plant. Cancer drugs are designed to kill cells, and not all such drugs are discriminating in which cells they kill, especially when they are "delivered" by casual contact. "Handling anticancer drugs is much more dangerous than handling other pharmaceuticals, which makes the drugs' manufacture at least an order of magnitude more complex," Chalabi said.
The new facility, which will open in December 1988, will be one of only a few facilities worldwide specifically designed to handle the most potent anticancer drugs. The plant will be fully Class 100,000-operated and will contain a series of production suites, a development laboratory, and drying/packaging rooms. Processing equipment will include glassware, 100 gallon reactors, and everything in between. A combination of barrier technologies and clean-in-place systems will eliminate the risk of cross-contamination with other products and ensure operator safety. The plant will cost "millions and millions of dollars" to build, according to Chalabi, and ChemSyn will require additional chemists and chemical engineers to populate the facility.
Chemsyn offers development as well as production services
Specialization or a Broad Range of Services?
ChemSyn has developed a reputation for providing anticancer bulk actives and other highly potent pharmaceuticals. Why specialize?
"Strategically, specialization is what we think will work for us," Chalabi stated. "Contract manufacturing is growing, yes, but there are so many contractors out there now, especially in Europe and Asia, with multi-ton capacity. Smaller contract manufacturers, like ChemSyn, have no choice but to specialize. Those that don't soon tend not to be memorable enterprises." Of course the area of specialization matters, too. "Cancer happens to be one of the hottest areas in pharmaceuticals today, with lots of drugs in the pipeline and no really effective battery of cancer drugs on the market. We're banking on having the right kind of manufacturing capability and expertise to exploit these market dynamics."
The Company
ChemSyn, founded in 1985, provides a full range of services, including bulk manufacturing under cGMP, process development and scaleup, process validation, analytical methods development, and custom radiosynthesis (carbon-14 and tritium). Since its founding the company has been the National Cancer Institute's repository for tumor promoter molecules used to induce cancer in test animals. ChemSyn, in fact, wrote NCI's official guidelines on handling carcinogenic compounds.
For more information: Phillip Chalabi, Sales and Marketing Manager, ChemSyn Laboratories, 13605 W. 96th Terrace, Lenexa, Kansas 66215-1297. Tel: 914-541-0525, ext. 234.