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N-mAb

The goal of the N-mAb initiative is to convene thought leaders to establish shared vocabulary and understanding by which the industry can think about integrated/continuous processes with respect to regulatory considerations.
Categories
Proteins/ Antibodies
Drug substance
Assays
Process control
Project status
100% Completed

Solution

The A-mAb case study (2009) created value in the biopharmaceutical industry by bringing industry and regulatory stakeholders together to develop shared expectations and vocabulary for quality by design. Participation included key thought leaders in industry and from relevant federal agencies. NIIMBL is committed to supporting and accelerating the adoption of integrated and continuous processes for manufacturing biopharmaceuticals.

The goal of the N-mAb initiative is to convene thought leaders to establish shared vocabulary and understanding by which the industry can think about integrated/continuous processes with respect to regulatory considerations. Specifically the key deliverable of this project is a published control strategy framework for a hypothetical integrated/continuous monoclonal antibody manufacturing process.

View and download N-mAb at https://niimbl.force.com/s/n-mab.

Outcomes and Impacts

Case study that supports teaching and learning for both industry and regulators around adoption of advanced manufacturing process technologies for mAbs

Updates, Related Publications, and Deliverables

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Project Lead

NIIMBL

NIIMBL

Participating Organizations

Amgen Inc.

Amgen Inc.

AstraZeneca

AstraZeneca

Bristol-Myers Squibb

Bristol-Myers Squibb

Catalent Pharma Solutions, LLC

Catalent Pharma Solutions, LLC

Federal Stakeholder:  National Institute of Standards and Technology

Federal Stakeholder: National Institute of Standards and Technology

Federal Stakeholder: Food and Drug Administration

Federal Stakeholder: Food and Drug Administration

Genentech

Genentech

GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

Janssen Research & Development, LLC

Janssen Research & Development, LLC

Just - Evotec Biologics

Just - Evotec Biologics

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono

Pfizer, Inc.

Pfizer, Inc.

Resilience US

Resilience US

Roche

Roche

Sanofi

Sanofi

Sartorius Stedim

Sartorius Stedim