AIBN-RACI Virtual Seminar Series: Development and implementation of a robust and flexible continuous downstream process for a biotherapeutics contract development and manufacturing organization
Event Details
- Date:
- Thursday, 10 September 2020 - Thursday, 10 September 2020
- Time:
- 12:00 pm - 12:45 pm
- Room:
- Online via Zoom
- Location:
- Online via Zoom
- URL:
- https://uqz.zoom.us/webinar/register/WN_cL08ZYbLSjy4D-f_GhuLTA
- Event category(s):
Event Contact
- Name:
- Ms Kahlia Bartley
- Phone:
- 64215
- Email:
- aibn.events@uq.edu.au
- Org. Unit:
- Australian Institute for Bioengineering and Nanotechnology
Event Description
- Full Description:
- Abstract: Biotherapeutics are widely prescribed to treat a variety of conditions and diseases including cancers, multiple sclerosis, psoriasis, Alzheimer’s, and rheumatoid arthritis. Recombinant proteins, the largest segment of the biotherapeutics market, showed continually market growth over the last two decades and is forecasted to continue. As an increasing number of new molecules and biosimiliars enter clinical trials, biopharmaceutical companies are outsourcing development and production to contract development and manufacturing organizations (CDMOs). Subsequently, CDMOs strive to adopt innovative manufacturing strategies like continuous bioprocessing to reduce cost and time. The latter is most critical for CDMOs, as reduction in process time translates to an increased number of batches per year, which is directly related to a CDMO’s profitability. Unlike traditional biopharmaceutical companies, CDMOs can work with a wide range of molecules and processes. Hence, it is necessary to develop a continuous bioprocess strategy that can be customized to suit client requirements. This project aims to develop a robust and flexible continuous downstream process, capable of rapid production of multiple molecules at different scales.
This seminar will cover a systematic approach to evaluating the potential of a fully continuous downstream process and a hybrid process (only the primary capture unit operation in continuous mode) for mAb manufacturing in a CDMO facility. Implementation of continuous downstream processing was assessed for a 2000 L fed-batch bioreactor producing 1, 5, and 10 g/L of mAb at 40 and 200 kg production demands. Additionally, a process risk assessment, experimental design, and scaled-down models for mAb and non-mAb continuous chromatography will be discussed.
Presenter: Kristina Pleitt, CBI PhD Student, (Lua Group)
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