IBC Life Sciences

Description

This two-day course will provide an overview of the management of movement of biologics from a starting point to the destination using examples from biologics manufacturing and other related products. An understanding of the relationship of the network that stores and moves the components including raw or starting materials of a product to the final delivery will be examined. The course includes inventory control of stock materials, work-in-progress from point of origin to point of shipping. Supply chains can range from the simple production of a product within a facility to a complex network involving a global complexity of transportation, partnering, international borders, etc. Tracking techniques for items through a supply chain such as bar codes and RFID will be discussed. Special requirements such as cold chains will be included. Supply chain management will be examined from the various aspects of resources, systems, costs analysis, use of outsourcing and networks.

Agenda

• Introduction: Definition of Supply Chain and Importance
• Supply Chains for Biopharmaceuticals: Macromolecules, Proteins, and Recombinant DNA
• Supply Chains for Genetically Engineered Vaccines
• Supply Chains for Monoclonal Antibodies
• Understanding the Components of Supply Chains for Biologics Manufacturing
• Typical Bio-Manufacturing Steps
• Regulatory Requirements for Biopharmaceuticals
• Importance of Chain of Custody
• Developing SOPs
• Pros and Cons of Disposable Bioreactors
• Cell Banking and Distribution
• Tracking Strategies - Bar Codes, RFID, the Role of IT
• Outsourcing, Partnerships and Alliances - Evaluating the Correct Solution
• Globalization - Complex Supply Chains (networks) that Involve Moving Product across Borders
• Costs Analysis Associated with Supply Chains
• Use of the Systems Approach
• Protecting Against Counterfeiting
• Role of Government Regulations
• Government DOT (Department of Transportation) Codes
• Strategies and Special Considerations

Who Should Attend?

• Procurement staff for biological starting materials
• Inventory Managers and Managers responsible for maintaining stock biologic starting materials
• Manufacturing Managers
• Laboratory personnel responsible for cGMP
• Employees responsible for packaging, labeling and shipping biologics
• Managers and Directors of research groups
• Biomanufacturing Managers
• IT Management, Manager and Director level

Instructor

Bonnie L. Robeson, Ph.D., M.A.S. Bio, Professor, Johns Hopkins University; President, Spectrum BioScience
Dr. Bonnie Robeson is a professor at the Carey Business School, Johns Hopkins University, where she teaches operations research and courses in the Life Sciences track. She is also the founder and president of Spectrum BioScience, a logistics company specializing in the management of research compounds used for discovery in the pharmaceutical and agro chemical areas. Dr. Robeson has a Ph.D. in Biochemistry from West Virginia University, a post-doc at North Carolina State University and a Masters of Administrative Sciences from Johns Hopkins University. She lives in Maryland splitting her time between the Baltimore metropolitan area and the beautiful mountains of western Maryland.