Diagnostic Hybrids Inc. manufactures discrete units of mammalian cell cultures and diagnostic reagents—such as antibodies—that are used to grow, isolate and type viruses. The company faced complex information-management challenges because of its many different product offerings, complex bills of material and high volume of units produced. These challenges were complicated by the high volume of production lots and the lot-tracking requirements imposed by the U.S. Food and Drug Administration. The company often had to produce finished cell culture products with expiration dates less than a week away. To maintain its average annual sales growth of more than 70 percent, the company decided to examine its shortcomings.

A hybrid of batch and discrete processes
Diagnostic Hybrids’ manufacturing processes can best be described as growing and cultivating living cells in a batch and dispensing the recipe material into specialized discrete units—tubes, vials and multiwell plates—suitable for use in a laboratory. The end products are used in medical laboratories to diagnose viral infections.

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