TrainingSeminars


Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, and extensive coverage of the basic science underlying each topic. Experienced Training Seminar instructors offer a mix of formal lectures, interactive discussions and activities to help attendees maximize their learning experiences. These immersive trainings will be of value to scientists from industry and academic research groups who are entering new fields – and to those working in supporting roles that will benefit from an in-depth briefing on a specific aspect of the industry.


TS2: Intro to Bioprocessing

CHI’s Introduction to Bioprocessing training seminar provides a comprehensive, yet technical, review of the critical steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. Whether you are new to the bioprocessing or looking for a recap, the 1.5 day seminar will take you through the critical steps of bioprocessing - from upstream to downstream processing, cell line development to CMC, clinical to commercial bioproduction. The courses also examines topical subjects such as continuous processing, facility considerations and process validation.

  1. Introduction
    1. Definition of biopharmaceutical products
    2. Impact of the Science
  2. Regulatory Considerations
    1. CMC activities
    2. Quality Systems and QbD
    3. Analytical Methods
  3. Manufacturing Operations
    1. Fed-Batch Unit Operations – Drug Substance Manufacturing
      1. Cell line and upstream processing
        1. Cell Banking
        2. Fermentation and Cell Culture
        3. Media Systems
      2. Downstream processing
        1. Separations
        2. Filtration
        3. Chromatography
        4. Viral Clearance
      3. Continuous Manufacturing
    2. Drug Product Manufacturing
      1. Formulation
      2. Lyophilization
      3. Fill/Finish
  4. Technology Platforms
    1. Stirred tank
    2. Single use
    3. ATMPs

       

  5. Facility Considerations
    1. Product-Process-Facility Attributes
    2. Segregation Strategy
  6. Scale-up and Clinical Manufacturing
    1. Scale-up considerations
    2. Clinical-to-Commercial Regulatory Expectations
    3. Product Launch
  7. Process Validation
    1. Qualification
    2. Supply Chain
    3. Licensure

About the Trainer:
Instructor:
Jeff_OdumJeff Odum, PhD, Independent Consultant

Jeff Odum is Principal, NCBiosource located in Raleigh, North Carolina. He has over twenty-five years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, and pharmaceutical industries.

A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over seventy articles and four Industry reference books on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project management and GMP compliance.

Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the ISPE Biotechnology Community of Practice Steering Committee, and a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management and commissioning and qualification. He is a member of the PDA and ISPE technical training faculties and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing and a Guest Instructor for the North Carolina Community College System BioNetwork Program. He has led training efforts in fifteen countries, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.