process development - Bioprocess Development Forum

Articles Regulatory

June 2, 2022

e-Learning: what is quality by design (QbD)?

This free interactive course shares what quality by design (QbD) is all about. The focus…

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Articles

February 24, 2022

Mechanistic vs Statistical Models

Mathematical models are recommended by the ICH Q8 guidelines on pharmaceutical development to...

Derek Author Smith

Articles Upstream

October 21, 2021

Cell Culture Media Selection Guide for Your Lab Wall

Doing cell culture and upstream process development on antibodies, vaccines, or viruses?

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Articles Downstream Upstream

September 9, 2021

Antibody Production Workflow

Antibody-based therapies have evolved beyond monoclonal antibodies (mAbs) to include bispecific...

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Articles Regulatory

July 29, 2021

The Role of CDMOs in Cell and Gene Therapy Process Development

An experienced contract development and manufacturing organization (CDMO) can ease scaling and tech...

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Articles Downstream Regulatory Upstream

July 15, 2021

Assessing Manufacturing Process Robustness

The pharmaceutical regulatory landscape and pharmaceutical development have been reshaped by...

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Articles Downstream Regulatory

April 22, 2021

Guide to Polishing Chromatography in Process Development

This article shares the factors you should consider when developing your polishing steps...

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Articles Downstream Regulatory Upstream

March 25, 2021

Basics in Process Development for Biotherapeutics

Definitions, activities, and things to consider when developing an upstream or downstream bioprocess.

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BioPharma Q&A Regulatory

August 27, 2020

Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development

Mechanistic modeling is considered a part of smart process development, which is a collection of...

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Articles Downstream Uncategorized

July 30, 2020

Vocabulary for Chromatography Column Packing

Packing a chromatography column is an art in itself and requires a certain level of…

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