Search results for " comparability"
Article
2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
Article
FDA Seeks Metrics to Define Drug Quality
…n policies; and reduce preapproval requirements for site transfers, assay improvements, and extended comparability protocols particularly for “good actors” in GMP compliance.
From the agency’s pe…
Article
Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“No, ” he said, “This is not really any different than the requirement for characterization of a new product—except, of course, one must demonstrate comparability or biosimilar similarity to an existi…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
This necessitated modifications to the purification process, which eventually allowed demonstration of comparability to the innovator and approval by the EMA (51). The success of a biosimilar developm…
Article
Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
As you may already know, many biopharmaceutical manufacturers are producing drugs at higher concentrations. This trend is mainly driven by the demand for subcutaneous drugs that are self-admin…
Webcast
Webinar: Intensifying Downstream Bioprocessing With Continuous Technologies
Significant operational improvements can be achieved by intensified continuous processes compared to standard batch processes.
In this webinar we will explore common bottlenecks in downstream pr…