The traditional methods used to make most solid pharmaceutical dosage forms (direct compression, wet and dry granulation, and capsule filling) are rapidly expanding to include extrusion, film casting, 3D printing, and many other emerging methodologies. The very manner in which these processes are developed and practiced has changed dramatically with the incorporation of Quality by Design (QbD) and Process Analytical Technologies (PAT), two initiatives spearheaded by the FDA that in the last decade have been adopted all over the world. Moreover, in the last few years, another wave of innovation has been growing exponentially – a worldwide movement to replace the traditional batch manufacturing processes with modern continuous methodologies.
Consequently, a growing number of patents focus on product (formulation) and process innovations. It is no longer enough to “own the molecule,” companies also seek to own the formulation, and the process, to maintain market exclusivity. All of this innovation also translates into rapidly evolving regulatory expectations regarding how products and processes should be developed, how manufacturing operations should be conducted, and how quality should be assured. Quality and regulatory compliance has become a moving target.
Whether you are an attorney involved in an IP lawsuit, or a pharmaceutical scientist trying to address a quality issue, our experts can help. They have been at the forefront of many of these initiatives, and are recognized all over the world for their knowledge and leadership in a wide range of areas, including:
- A comprehensive array of product manufacturing methodologies
- All relevant ingredients, blend, and finished product testing methodologies
- Extensive process modeling and simulation capabilities
- Authorship of an extensive body of technical literature
