Regulatory - Bioprocess Development Forum

Articles Regulatory

January 12, 2024

Dear lentivirus: We have not forgotten about you and how to improve your polishing recovery

Lentiviruses are commonly used for both chimeric antigen receptor (CAR) T cell therapy and ex...

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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 BioPharma Downstream Regulatory Upstream

August 30, 2021

Cell-free Expression Systems Pose Cell Culture Alternative

Among the challenges in upstream bioprocessing is the cellular waste generated as a by-product...

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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 Regulatory

July 29, 2021

Novavax Reports on Two Vaccine Efficacy Studies

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an...

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