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.

admin-element

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...

admin-element

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...

admin-element

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…

admin-element

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…

admin-element

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...

admin-element

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…

admin-element

Articles Downstream Regulatory Upstream

May 25, 2016

An Integrated Approach to Ensure the Viral Safety of Biotherapeutics

Use of continuous cell lines in the manufacture of biological therapeutic products, such as...

admin-element

Articles Downstream Regulatory Upstream

January 13, 2014

PDA’s Technical Report for Biotech Cleaning Validation

Cleaning validation plays an important role in reducing the possibility of product contamination...

admin-element