regulatory - Bioprocess Development Forum

Articles Regulatory

October 5, 2024

2024 Global Biopharma Sustainability Review

CytivaThis report is based on data from 800 pharma and biopharma professionals at director-level and…

Ross Burns

Articles Regulatory

February 9, 2024

Paring Down Impurities in Downstream Processing

Myriad choices confront manufacturers before they even consider optimizing downstream processes.

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Articles Regulatory

December 1, 2023

Getting your investigational drug regulatory ready

Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational...

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Articles Regulatory

August 25, 2023

A risk based approach to sterile filtration

Drug quality cannot be assured only by finished-product testing. Process validation is required to...

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Articles Regulatory

June 13, 2023

Simulation gets therapies to patients faster and smarter

Digital solutions are helping to decrease therapeutic time to market but remain challenging – learn…

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Articles Regulatory

June 2, 2023

The Smart Benefit of Digital Systems in Preclinical Studies

The advancement of smart drug development reaches far back in the drug development cycle, starting…

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Articles Regulatory

January 26, 2023

How Well Do You Know Process Development?

HTPD. DoE. Process understanding. Check your mastery of these and other essential terms by taking...

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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 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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Articles BioPharma Downstream Regulatory Upstream

July 2, 2019

Addressing the Complex Nature of Downstream Processing with QbD

Regulators have been encouraging bio/pharmaceutical companies to incorporate the concept of...

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