CONFERENCE SERIES: Bioprocess & Manufacturing
Recorded at: The Bioprocessing Summit
About this Course:
Researchers need to be ever more productive to meet the demands of a burgeoning biomedical industry. As cell culture reaches greater productivity, pressures increase downstream to keep up with production. Traditional approaches and techniques consistently require innovation to streamline tasks, while at the same time, costs need to be contained or reduced.
Operational Excellence strategies are being employed in bioproduction to drive innovation, increase production, and cut time as well as costs. This digital course provides an overview of current Operational Excellence strategies, and how they are applied in bioprocessing.
Topics covered include:
- Quality by Design (QbD)
- Design of Experiment (DoE)
- Process Analytical Technology (PAT)
- Continuous Improvement
- Lean Manufacturing
- Six Sigma
- Regulatory perspectives and guidance
Take advantage of the experiences and insights from these learned instructors, who share case studies and actual results. Take the time to add to your toolbox of skills and knowledge, and learn how experts in the field are staying ahead of the competition.
About this Product:
Over 122 Minutes
Site License: $1380
Agenda At A Glance:
What is Operational Excellence? An Introductory Overview
Joyce C. Chiu, M.B.A., CPIP, Senior Project Leader, Honeywell Safety Products
Joyce has over 25 years in process engineering, product development and program management across diverse industries and technologies, including coated thin films for imaging and photography, microelectronic materials for semiconductors, hand-held displays for eBooks, hot-melt and injection molded products. Her life science experience includes medical devices, single-use disposable systems for bioreactors and mixers, client services project management of interactive systems for clinical trials. Joyce has expertise in material intensive product and process development, stage gate process, quality systems, statistics, six sigma, supply chain and operational excellence. She holds a BS Chemical Engineering from Cornell University, an MBA from Babson College, summa cum laude, and a Certified Pharmaceutical Industry Professional (CPIP) credential by ISPE in 2010.
Quality by Design in Biopharmaceutical Development
Susan Dana Jones, Ph.D., Vice President & Senior Consultant, BioProcess Technology Consultants, Inc.
Susan Dana Jones is a seasoned biotechnology entrepreneur with experience in biopharmaceutical discovery, product development, and strategic planning. She co-founded two successful biotechnology companies and has managed multiple discovery and product development programs. Dr. Jones is a subject matter expert in cell line development and characterization and is a leader in applying the principles of Quality by Design (QbD) to early stage biopharmaceutical development programs. She currently advises clients on the advancement of product candidates from research through development. Dr. Jones also assists clients in the application of GMP regulations and preparation of regulatory submissions as well as performing technical due diligence in support of investors or mergers and acquisitions. Dr. Jones is a frequently invited spealer at industry conferences and symposia and also serves as a guest lecturer at Northeastern University. She is a member of the Board of Directors of Gene Solutions, LLC, the Symphogen A/S Scientific Advisory Board, the Editorial Advisory Board of BioProcess International. Prior to joining BioProcess Technology Consultants, Dr. Jones was Senior Vice President of Corporate Development at Serenex, Inc, where she worked with other senior managers to complete a $15M Series B financing. Prior to Serenex, she was Vice President of Product Development at Waratah Pharmaceuticals and previously held development and management positions of increasing responsibility at Peptimed Inc., Virus Research Institute (now Celldex Immunotherapeutics), IntraImmune Therapies Inc., and Dyax Corp. Dr. Jones received her Bachelor's degree from Harvard University, holds a Ph.D. in Genetics from the University of California, San Francisco, and performed post-doctoral research at the Dana-Farber Cancer Institute of Harvard Medical School.
Using PAT and DoE in Biopharmaceutical Process Development
Sheila Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.
Sheila Magil has over 20 years of experience developing manufacturing processes and analytical methods for small molecules, peptides, and biologics. She currently provides support to clients in the areas of analytical development, quality control, and quality assurance. Dr Magil also supports clients by performing regulatory compliance audits and assessing CMC related risks for products under consideration for acquisition. Prior to joining BioProcess Technology Consultants, Dr. Magil was Senior Manager, Analytical Development and Quality Control at Biomeasure, where she was responsible for creating the company's Biologics Quality Control department and managing external analytical and quality control for a new biologic product. She was also a member of the project team overseeing the construction of a new biologics manufacturing plant. As Vice President at Waratah Pharmaceuticals, Dr. Magil managed external process development and production of both peptide and protein therapeutics and also managed the toxicology testing of these products. At Alkermes, Dr. Magil was a Sr. Research Scientist in the formulation department working on new analytical methods for formulation development for several protein and peptide products. She also worked at Bion, Inc, and the Howard Hughes Medical Institute and the Massachusetts General Hospital providing direction to the core laboratory serving investigators at three institutions. Dr. Magil holds a Bachelor's degree in Chemistry from Carnegie-Mellon University and a Ph.D. in Biochemistry from the University of Minnesota Medical School.
About the Conference:
Each year, Boston hosts CHI’s "The Bioprocessing Summit" which focuses on the most pressing challenges of bioproduction. From cell line selection and transfection, to biopreservation, scale-up and bioreactor design, this event explores the bioprocesses that continually consume time and resources. The six meetings comprising the Summit provide a close-up look at the current strategies and innovations for optimizing bioprocesses while mitigating risk and ensuring bottom-line quality.
Rather than ‘mile-high’ perspectives, the Summit experts examine the steps and protocols they have refined to help you with your work at the bench, and reveal their engineering and process breakthroughs that move bioprocessing into the future. The event features interactive small-group discussions, exhibits, panel discussions, extensive poster display, and networking with colleagues from around the world.