By Wayne Koberstein, Executive Editor
In the American South, below the old Mason-Dixon Line, you can walk down some house-lined streets in summer and see tidy plantings of tobacco growing in the front yards. Tobacco barns, built for drying, not storing, are as common down there as hay barns in Wisconsin.
By Kevin Ward, Biopharma Technology Limited
Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced.
By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Process equipment choices, whether multiuse or single-use, are commonly made early in medicinal drug development activities, and in test labs. Choices made in the test lab about which equipment would be tested are often dependent on either the availability of the equipment or knowledge about it. This often results in a legacy equipment choice. However, since the volumes used within the early drug development stages are very small, the process equipment used might not represent the process-scale design or, even worse, is not scalable to process volumes. A proper plan and scalability investigation should precede the choice and testing of equipment, especially those that are single use.
By Robert G. McGregor, General Manager – Global Marketing, Brookfield Engineering Laboratories, Inc.
Material flow behavior may include the phenomenon called “creep,” which applies to various liquids and semisolids such as gels and lotions that continue to move slightly even after placement on the skin. R&D’s intent when formulating the substance is to minimize movement, because the medicinal effect is best accomplished by keeping the material in the original position where it is applied.