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:

  1. Process data acquisition hardware and software installed and validated
  2. SM Profiles created for precipitation and dewatering modules
  3. SMIP instances, connectivity established for precipitation and dewatering
  4. Predictive models for precipitate morphology and critical filtration flux, dashboards developed
  5. 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.

 

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

 

SUBSCRIBE TO OUR NEWSLETTER
BECOME A MEMBER
Our ecosystem is inclusive by design,
and everyone has a role to play.
Come find yours!


JOIN US >

LOCATION

Headquarters: Los Angeles, California
(888) 720-8096 | info@cesmii.org