In the development of a dosage form for a new or generic chemical entity, a formulator generally relies on his past experiences to assist him in making decisions. These past experiences can vary with the knowledge and experiences of each individual formulator. Understanding how to manage and use knowledge is an essential aspect of the formulation and process development and manufacturing paradigm.
Why Knowledge Management?
Better knowledge management equals better quality
Knowledge management is essential to building quality into products. It provides opportunities for improving manufacturing efficiencies through technological innovation. With an emphasis on building quality into products, knowledge management allows a focus on relevant multi-factorial relationships among material, manufacturing process, and environmental variables and their effects on quality. These relationships provide a basis for identifying and understanding thr relationships among various critical formulation and process factors and for developing effective risk mitigation strategies (e.g., product specifications, process controls, training). The data and information to help understand these relationships are obtained through preformulation programs, development and scale-up studies, and from manufacturing data collected over the life cycle of a product.
Knowledge Management is systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components. Knowledge management can facilitate manufacturing process development. Sources of knowledge include, but are not limited to, prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.
Background knowledge is information that is essential to understanding a situation or problem. It is acquired through study or experience or instruction.
Prior Knowledge in Formulation and Process Development
So what does one mean by ‘Prior Knowledge’ in formulation and process development? Prior knowledge is the knowledge the learner already has before they meet new information. It may be acquired through study, instruction or experience. With respect to formulation and process development, it is information that is useful to understand a situation or problem. Prior knowledge can include established biological, chemical, and engineering principles; technical literature; and applied manufacturing experience. Data derived from relevant prior knowledge, including platform manufacturing can be leveraged to support development of the commercial process and expedite scientific understanding. This prior knowledge may include knowledge about the physical and chemical properties of excipients, their compatibility with various types of chemical entities, their processing characteristics in wet or dry process providers, compression properties, etc.
Platform Manufacturing is the approach of developing a production strategy for a new drug starting from manufacturing processes that are similar to those used to manufacture other drugs of the same type (e.g., as in the production of monoclonal antibodies using predefined host cell, cell culture, and purification processes, for which there already exists considerable experience).
Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. Development activities using scientific approaches provide knowledge for product and process understanding. The emphasis should be placed on prior knowledge as part of knowledge management as a means to supplement the decision-making process for formulation and process development and manufacturing activities.
For additional information and general considerations on how knowledge management can be used in formulation and process development, and manufacture please fill out the contact form on this page.