Smart Downstream Processing of Monoclonal Antibodies (mAbs)

Project Lead: Rensselaer Polytechnic Institute 
Partners: Pennsylvania State University, Rensselaer Polytechnic Institute, Johnson & Johnson, Janssen Pharmaceuticals 

Member % Cost Share: 50%
CESMII % Cost Share: 50%
Duration: 6 Months

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 & 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

Potential Impact

  • 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 

Benefits

  • 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.

Project Selection & Announcements

CESMII_RFP
CESMII_RFP
CESMII_RFP

Leverage project outcomes for your manufacturing operations

Learn More