PROJECT LEAD: Rensselaer Polytechnic Institute
PARTNERS: Pennsylvania State University, Rensselaer Polytechnic Institute, Johnson & Johnson, Janssen Pharmaceuticals
PROBLEM STATEMENT: The common current or “platform” process for making monoclonal antibody-based drugs (mAbs) is insufficient to meet domestic or global pandemic needs. The Protein A chromatography capture step is the bottleneck.
PROJECT GOAL: Implement the CESMII SMIP for an alternative precipitation-based capture step to debottleneck process, focusing the precipitation and precipitate dewatering modules. The SMIP facilitates adoption of the new process by biomanufacturers.
TECHNICAL APPROACH: Instrument precipitation and dewatering modules; construct SM Profiles; create instances of SMIP connecting to edge device; create semi-empirical models for precipitate particle morphology and critical flux during dewatering; create process data dashboard; develop model-based feedback control of precipitation module; develop model-based feedforward control of dewatering module; demonstrate process operation under SMIP environment.
KEY TASKS AND MILESTONES:
- Process data acquisition hardware and software installed and validated
- SM Profiles created for precipitation and dewatering modules
- SMIP instances, connectivity established for precipitation and dewatering
- Predictive models for precipitate morphology and critical filtration flux, dashboards developed
- Integrated capture process demonstration and impact assessment completion
- Establish core of new debottlenecked mAb downstream process
- Meet FDA goal of fully continuous mAb downstream processing
- Control protein particle morphology: mAb ppts as well as virus-like particles, solid drug product phases
- Facilitate tech transfer and widespread adoption of new process using CESMII’s SMIP
- Reusable and adaptable SM Profiles for precipitation and microfiltration
- Particle morphology and filtration critical flux prediction Apps in SM Marketplace
- Linkage between CESMII and NIIMBL
- Biotechnology industry use case example for SMIP and SM Profiles.
|Member % Cost Share||CESMII % Cost Share||Duration|