Technical and operational challenges to pharmaceutical Continuous Manufacturing (CM) implementation

Continuous Manufacturing (CM) is undoubtedly a hot topic in the pharmaceutical industry, with most companies either evaluating CM, running pilot CM programs, or actively deploying CM for both new and existing products.

The intention of this presentation is to share some of the technical and operational challenges around pharmaceutical CM implementation, including initial justifications for going continuous, the impact of making the change to CM on process development, including the development of Control Strategy (including explaining current thinking around the Control Strategy complexity pyramid), and the role of PAT in this paradigm change.

Examples will be used from small molecule active pharmaceutical ingredient (API), and all three common drug product formulation types (direct compression, wet granulation and dry granulation).


Martin Warman - Martin Warman Consultancy Ltd.

Martin is Director of Martin Warman Consultancy Ltd, providing services to support QbD and PAT-enabled Control Strategies for both batch and continuous manufacturing. Previously, he spent 7 years as a Scientific Fellow II at Vertex Pharmaceuticals supporting the use of PAT within a QbD framework, from process development to part of a Control Strategy for real time release. This included a special focus on Continuous Processing and Process Innovation. He has over 20 years’ experience working in this field, having previously led the PAT Development Team of Pfizer Global Manufacturing.

Before joining Pfizer, Martin worked for Dionex, providing application support for liquid and supercritical fluid chromatography, including on-line measurements in the environmental and nuclear industries. He joined Dionex from Shell Research, where he provided analytical support, developing novel environmental analysis methods and technologies in support of Shell's bio-restoration/bio-remediation projects, and environmental monitoring programs in the North Sea.

Martin has also worked in academia, starting his career at the University of Westminster specializing in BioProcessing, and he has a bachelor’s degree in Cell Biochemistry.

This provides extensive, cross-industry, experience in application identification, solution specification and delivery, as well as the support of systems during product life-cycle. He also has experience in a developing and implementing a wide variety of measurement solutions, from spectroscopic, through chromatographic, and including acoustic and particle characterization.

Martin is also on the Executive Committee of ASTM E55 covering Pharmaceutical Manufacturing, and chairs the E55.01 sub-committee covering PAT.


Who should attend?

Formulation Development
Senior process engineers and scientists leading process development activities.

Material Scientists
Those responsible for translating material attributes into process performance, and therefore product quality

Analytical Development
Team leaders and those responsible for development of methodology which will support the GMP control strategy (as defined in ICH Q8 (R2). Familiarity with the current ICH Quality Guidelines will be a benefit.

Quality Operations
Those responsible for development of the a Quality system/framework in which a continuous manufacturing control strategy can be operated

Regulatory Affairs
Those responsible for understanding, drafting and leading the interactions with the regulatory agencies, will get a wider understanding of the scientific and engineering considerations behind the technical aspects of the regulatory interactions behind a CM submission.