Biomanufacturing Optimization: Improving Upstream Productivity
Implementing Better CMC Strategies
Welcome
Today’s goal is to learn from bioprocessing industry experts who have "walked the talk," to apply their advice so your company can improve process efficiency and accelerate approval success. Experts Philip Probert, Robert Dream and Tiffany Rau have agreed to sit down with fellow industry expert Susan Dana Jones to: (1) discuss how your company can identify and implement the right technologies and tools to support mRNA development and manufacture; (2) highlight how and why your company should re-evaluate existing strategies to improve process efficiency; and (3) learn from a case study on how to successfully transfer technology and scale up a CHO process.
BIOMANUFACTURING OPTIMIZATION - A conversation with Philip Probert, Centre for Process Innovation
Philip Probert, biologics technology lead at CPI shares his experiences and provides his advice on the latest tools and technologies supporting mRNA development and manufacturing, including: (1) mRNAs potential to treat previously untreatable diseases; (2) Process similarities to microbial and mammalian; (3) Using analytics to characterize and assess product purity; (4) Conducting proper D0E to ensure process design supports scalability; (5) Designing flexibility into your production platform; (6) Accessing the best technologies to accelerate process success
BIOMANUFACTURING OPTIMIZATION – A Conversation with Robert Dream, HDR Co.
Robert Dream, managing director at HDR Co. shares his experiences and provides his advice on how biopharma companies can and should re-evaluate existing production strategies to improve process efficiency, including: (1) Creating a holistic vision to biomanufacturing; (2) Designing a flexible technology framework; (3) Successful implementation of a plan to achieve operational excellence; (4) Emphasizing safety, quality, efficacy and regulatory mandates; (5) The bottom line – Delivering ROI
BIOMANUFACTURING OPTIMIZATION – A Conversation with Tiffany Rau, Bio Pharma Technical Consulting
Tiffany Rau, managing director, Bio Pharma Technical Consulting, shares the lessons learned along with her advice relating to a recent case study where a client successfully transferred and scaled-up a CHO process, including: (1) Managing equipment differences through lifecycle; (2) Designing and controlling process inputs for successful scale-up; (3) Multi-faceted communication to ensure accurate data transfer; (4) Improving process efficiency to facilitate product approval.
