Search results for " facility" in Articles / App Notes
Article
Selecting the Right Viral Clearance Technology
“When those processes advance to commercial production with regular manufacturing and carefully orchestrated facility constraints, however, any variation in performance from batch to batch can disrupt…
Article
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
Article
USP Stresses Pharmacopeial Standards at CPhI China
Jun 29, 2015
By BioPharm International Editors
The United States Pharmacopeial Convention (USP) hosted a pharmacopeial and regulatory compliance seminar at the 2015 CPhI China conference, he…
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
A Bright Future for the Plasma Fractionation Industry
There is still a very bright future for the plasma fractionation industry. That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful isla…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
To further reduce the risk of aggregates, FDA also recommends selection of an appropriate cell substrate, a facility that employs GMPs, a robust purification protocol, and formulation/container closur…
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Cellbag culture chambers (containers) were manufactured at a Cytiva pilot manufacturing facility in Westborough, MA, US. Gamma irradiation of containers was performed by Steris Isomedix, Northborough,…
Article
New Era for Generic Drugs
Small manufacturers asked FDA for reduced annual facility and filing fees, and several industry executives urged more clarity in how new guidance would be implemented. They offered specific comments o…
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …