Continuous manufacturing has served as a longstanding process in multiple industries and in recent years it has developed within the biotechnology sector. As companies seek to lower the capital and operational cost of the manufacturing process for their biological drug, adopting a continuous or semi-continuous train to process development has increased in popularity.
Although continuous manufacturing presents significant benefits such as increased productivity and reduction of human error, it is still a new concept which comes with a lot of tacit knowledge to be developed and questions to be answered.
Over the course of 5 weeks, the course will address questions and challenges in continuous manufacturing by providing a step-by-step guide on how to adopt a continuous process, complemented by real-life case study examples and an overview of the regulatory landscape.
Richard has over 30 years’ experience in the biopharmaceutical industry at companies such as Celltech, Centocor, GSK, Protherics and BTG. Richard’s expertise includes product technology transfer utilizing program management methods and is well versed in regulatory agency requirements. Richard also has experience in the implementation of QbD approaches for biopharmaceutical products, process and analytical development requirements and has held senior management roles for process development, technical support, manufacturing operations and product lifecycle programs.
Richard has had significant involvement in the regulatory agency submissions both preparation of content and interaction with regulatory agency staff, covering many FDA, EMEA, Japanese and rest of the world approved biological products. In addition, Richard has had direct involvement in manufacturing site agency inspections and compliance audits.
Richard has worked with a diverse set of product types including monoclonal antibodies, polyclonal antibodies, recombinant DNA proteins, plasmid DNA and viral gene therapy products at all stages of their life cycle development.
This course is suitable for professionals working in:
PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Once you have registered you will be given login details to access the course