Search results for "analytics"
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work?
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services…
Article
Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
Top Process Development Trends for 2022 and a Look into 2023
In parallel, brought on by the obvious commercial success of the warp speed program for COVID-19 vaccines, came a need for reduced timelines, which accelerated the ongoing Industry 4:0 analytics, digi…
Article
Report from the 12th Plasma Product Biotechnology Forum
Since the first meeting in 1999, the PPB forum has established itself as the key international forum for the plasma manufacturing industry – read our report for the highlights of the 2022 conference…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
…to harvest, which results in the need for careful design of downstream processing steps and related analytics, are being addressed through the development of new transfection agents with improved pro…