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Technology Transfer Provides Manufacturing-Process Control
It’s easy for pharmaceutical professionals to be absorbed in the particular part of the manufacturing process for which they’re directly responsible. Operators concentrate on keeping their segment of the production process running smoothly. But the whole manufacturing line can be improved, even before production begins, if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.
Technology transfer contributes Quality-by-Design (QbD) principles by identifying critical quality attributes, the key manufacturing parameters that affect those attributes, and ways to control those manufacturing parameters, according to Paul Wlodarczyk, vice-president of solutions consulting for JustSystems North America (New York).
A company’s development department plays an important role in this process, he adds. Development personnel help identify critical process parameters as part of a general recipe. The process parameters are thus associated with a certain set of manufacturing actions specified for equipment and materials classes, says Wlodarczyk.
A general recipe can be converted into a master recipe for batch control in a specific plant at a given scale. “This conversion is a matter of identifying which recipe parameters are sensitive to scale and replacing class-based parameters with instance-based parameters,” Wlodarczyk explains.
Ideally, development and manufacturing teams share a common information model for process definitions. “This model would capture process definitions and parameters in a machine-readable format that can be rendered into documents for human interactions,” Wlodarczyk says.
Technology transfer then brings QbD limits and definitions from development to the manufacturing process, explains Mike Power, life-science supply-chain manager at BearingPoint (Mclean, VA). When systems such as enterprise resource planning and laboratory information management are linked to development-process knowledge, says Power, the transfer is accomplished quickly without human error.
Startup and process definitions directly affect manufacturing yield and waste, Power notes. When technology transfer transmits QbD limits and definitions to manufacturing, “waste is reduced by eliminating trial and error in setting up the process,” he says. By giving manufacturers complete knowledge of the process and a framework for continuous improvement, technology transfer improves yields.
In several ways, technology transfer enables continuous improvement of the manufacturing process. After ensuring that the process is clearly defined with general recipes, technology transfer sets the stage for recipe harmonization. Recipe harmonization, the use of common formats for all recipes across the product life cycle, forms a basis for process-knowledge management, says Wlodarczyk.
In turn, harmonization allows operators to define and reuse repeatable manufacturing actions, which are the building blocks of recipes. This process, recipe normalization, “provides a mechanism for continuous improvement,” he adds.
When technology transfer is performed correctly, it benefits all stages of a product’s life cycle. To begin with, “technology transfer, combined with QbD and programmatic interfaces to commercial manufacturing systems, greatly reduces time to market,” Power says.
Wlodarczyk agrees. “Effective technology transfer affects time to market most during the 12–48-month period it takes to scale up from pilot to commercial scale,” he explains. Recipe harmonization and normalization can reduce the time to achieve commercial-scale production by months, he adds.
Once their product enters the market, manufacturers must scale production up or down during their products’ lives in the marketplace and according to customer demand. “Each time there is a change in scale, there is technology transfer,” Wlodarczyk points out. Technology transfer “is critical for achieving rapid scale-up with control over how the manufacturing process is achieved,” he says.
Effective technology transfer is particularly important when conveying manufacturing-process knowledge about current products to contract manufacturers. “By using recipe-based process definitions, outsourcers can better prescribe not just what to make but how to make it, including control over critical and key parameters,” Wlodarczyk observes.
If a pharmaceutical company gathers process knowledge, communicates it internally, and keeps it current, it has great control over its manufacturing process. By efficiently managing process knowledge, technology transfer provides this control and ensures high-quality products.