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Updated: Jul 3, 2026

Laboratory Scale Production and Purification of a Therapeutic Antibody
Published on: January 24, 2017
The art of antibody process development.
David E Steinmeyer1, Ellen L McCormick
1Global Biologics, Pfizer Global Research & Development, Chesterfield, MO, USA. david.e.steinmeyer@pfizer.com
Developing therapeutic antibodies involves complex manufacturing processes, often seen as a
Area of Science:
- Biopharmaceutical drug development
- Therapeutic antibody manufacturing
- Process technologies
Background:
- Biopharmaceutical drug development takes over a decade from discovery to market.
- Therapeutic antibody development faces significant manufacturing challenges.
- Process development and large-scale biomanufacturing are specialized industrial practices.
Purpose of the Study:
- To provide insight into antibody process development.
- To elucidate the 'black box' of biotherapeutic manufacturing.
- To aid understanding for the medical community regarding novel medicine production.
Main Methods:
- Review of current antibody process development techniques.
- Explanation of manufacturing technologies for biotherapeutics.
- Discussion of challenges in scaling up antibody production.
Main Results:
- Antibody process development is complex and requires specialized expertise.
- Manufacturing technologies are crucial for bringing novel medicines to market.
- Understanding these processes demystifies biomanufacturing for medical professionals.
Conclusions:
- This article clarifies the intricate antibody process development lifecycle.
- It highlights key manufacturing technologies essential for novel biotherapeutic medicines.
- The insights aim to bridge the knowledge gap for the medical community.
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