Challenges and Issues in Biologics Drug Product Development

Challenges and Issues in Biologics Drug Product Development

Charlene Brisbane


The development of biologic drug products has unique challenges and issues due to their large size and complicated structure. In this presentation, these challenges and issues will be explored including:
  1)  Route and administration of biologics and delivery limitations.
  2)  Formulation requirements for biologics including causes of instability and means of stabilizing biologics, as well as, analytical techniques used to evaluate biologics and the associated studies.
  3)  Considerations for manufacture of biologic drug products including container closure options, aseptic manufacturing and the studies associated with developing a drug product manufacturing process for biologics.
In addition, several case studies will be provided which explore how challenges specifically related to the inherent nature of the biologic were overcome. The first case study showcases a biologic with a propensity to form visible particles and the second case study focuses on a dosing challenge with a highly potent biologic.


Date and Location


Thurs Feb 15th, 2018

Registration: 5:30 PM
Dinner & Presentation: 6:30 PM

Meeting Sponsors




Hanover Marriott

  • 1401 Rt 10 East,
  • Whippany, NJ 07981
  • About the speaker

    Currently, Charlene Brisbane is the director of Drug Product Development and Operations in Biologics, CMC at Teva Pharmaceuticals in West Chester, PA. She has almost 30 years in the biopharmaceutical industry. Charlene’s experience involves leading the formulation and process development of drug product from FTIH to commercial launch including management of people and projects, talent evaluation, mentoring and coaching and working in cross-functional matrix teams, authoring and reviewing regulatory submissions, technology evaluation and drug product technology transfer to commercial sites. Charlene started her career at J&J and was there for almost 8 years followed by almost 20 years at GSK before joining Teva in 2016.


    Registration Fees

    • Registered and paid online:     $50.00
    • Walk-in:     $65.00
    • Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY):     $45.00

    Advance registration will end at 5:00 PM on TUESDAY FEB 13th;  after that, you must pay at the door.  Note also that if you choose the "Register Now and Pay at Meeting" option, you must proceed all the way to the "Your Order is Confirmed" screen or your registration will not be recorded.

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