Biopharmaceuticals: Introduction to Large Molecule Therapeutics

Biopharmaceuticals: Introduction to Large Molecule Therapeutics Training Course (T66) New Course!

Overview

This new instructor led course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and analytics. The need for Quality by Design in all aspects of biopharmaceutical development will be emphasized. Lastly, we’ll highlight the differences between small molecules and biomolecules (large molecules). The purpose of this course is to provide a fundamental understanding of the CMC aspects of biopharmaceuticals from development to market.

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What You Will Learn

  • Biopharmaceutical CMC Development
  • Difference in Small Molecules and Large Molecules
  • Protein Complexity
  • Antibody Structure
  • Therapeutic Modality
  • Advantages and Limitations of Biopharmaceuticals
  • General Scheme for Biopharmaceutical Manufacturing
  • Analytics in Biopharmaceuticals
  • Cell Line Development (Mammalian and Microbial)
  • Cell Bank Creation and Characterization
  • Product Formulation
  • Analytical Methods
  • Regulatory Guidance
  • Isolators & Restricted Access Barriers
  • Quality by Design (QbD)
  • Validation
  • Comparability

Resources and Activities

  • Pre-Course Work Materials
  • Interactive Exercises
  • Learning Assessments

Course Modules

  • Overview of the Biopharmaceutical Development Process
  • Early Phase Development
  • Late Phase Development

Who Should Attend

  • Individuals who want to improve their working knowledge of biopharmaceutical development
  • Service organizations, suppliers, and vendors who serve pharmaceutical industry Clients focused on biopharmaceutical manufacturing
  • Academic institutions engaged in biopharmaceutical development/manufacturing
  • Vendors and suppliers of equipment/systems focused on the global biopharmaceutical launch process
  • Members focused on manufacturing risk assessment/mitigation
  • Quality assurance and quality control specialists
  • Validation specialists

Additional Course Details

Communities of Practice (COP)

This training course will be of particular interest to:


Daily Schedule and Pricing

  • online-live
    Online Live
    23 Aug 2022

    Daily Schedule at a Glance

    Training course times are listed in Eastern Standard Time (ET). Find your personal viewing time on the World Clock.

    0830 – 0845 Login
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1230 Wrap-up, Questions, Discussion

    Registration Fee

    REGULAR
    Member US$ 870.00
    Nonmember   US$ 1,000.00
    Government / Academia / Emerging Economies* US$ 250.00
    Student* US$ 90.00
    *ISPE Membership is required for these registration rates.

    Now Your Whole Team Can Participate in an ISPE Learning Experience

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


    Cancellations/Refunds

    Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.

  • online-live
    Online Live
    17 Nov 2022

    Daily Schedule at a Glance

    Training course times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.

    0830 – 0845 Login
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1230 Wrap-up, Questions, Discussion

    Registration Fee

    REGULAR
    Member US$ 870.00
    Nonmember   US$ 1,000.00
    Government / Academia / Emerging Economies* US$ 250.00
    Student* US$ 90.00
    *ISPE Membership is required for these registration rates.

    Now Your Whole Team Can Participate in an ISPE Learning Experience

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


    Cancellations/Refunds

    Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.