Allan J. Clarke

Novel Manufacturing Technologies for the Production of Patient-Centric Drug Products

The dose forms that the pharmaceutical industry provides to elderly patients are far from ideal in many regards, and recent trends in the industry have emphasized the potential benefits that may be obtained by emphasizing the patient’s needs in the formulation and manufacturing design process (as noted by Van Riet-Nales et al. [1], Stegemann et al. [2]), i.e., “age-related formulations.” Naturally, the physical and chemical properties of the active pharmaceutical ingredient (or “API”) constrain the set of viable potential dose forms, and biological factors, which have a significant influence on oral drug absorption in a wide range of patient groups, are critical aspects of formulation and manufacturing process selection. The development of an oral drug product that can be manufactured using a robust process is a critical element both of providing a suitable medicine of appropriate quality to the patient and a commercial return to the pharmaceutical company. Within this highly constrained design problem, it may be possible for the industry to develop new approaches by thinking creatively about the entire set of highly connected formulation and manufacturing challenges, and to remodel factory operations or, potentially, whole supply chains. Regulators, and the pharmaceutical companies themselves, have historically taken a conservative approach to novel manufacturing technologies that may offer quality and cost advantages over the conventional supply chain paradigms. Innovations, in the examples discussed below, will not be adopted rapidly, as change on such a scale occurs slowly. However, it is interesting to consider the benefits that such drug product manufacturing innovations might provide to patients. In recent years, regulators and the industry have sought to develop such approaches that not only offer patient benefits but that do so at commercially acceptable costs, and which are designed using robust and established manufacturing engineering principles.