Search results for " design"
Article
Critical Quality Attributes Challenge Biologics Development
Challenges for biologics
BioPharm: Are there specific challenges to identifying CQAs in biologics when applying quality by design (QbD)?
Das (BMS): Knowledge-based design, as opposed to a heur…
Article
Ensuring the Biological Integrity of Raw Materials
Animals should be less than 30 months old, designated for human consumption, and test free of all forms of transmissible spongiform encephalopathy. And there should be a quality assurance system in pl…
Poster
FlexFactory™ Automation
To enable compliance with regulatory requirements, FlexFactory Automation is designed according to GAMP™ 5 guidelines (ISPE).
Article
Fast Turnaround with Automated Column Packing
AxiChrom™ columns have been designed for easy and reliable packing. Preprogrammed, verified, and automated packing methods, together with a purposeful column design, enable one operator to quickly ach…
Article
Framing Biopharma Success in 2016
FDA’s expedited pathways for drug approval have proved successful; 60% of the 2015 approvals were designated in one or more of the expedited pathways (fast track, breakthrough, priority review, and ac…
Article
Selecting the Right Viral Clearance Technology
She adds that mapping the design space of a process step for viral clearance is the best way to optimize the step for virus reduction and is the approach generally used to understand the clearance pot…
Article
Biopharma Advances Demand Specialized Expertise
This reorganization was designed to enhance quality drug assessment by realigning several elements of the preapproval and surveillance inspection process. Integrating risk-based review, GMP inspection…
Article
Quality Systems Key to Lifecycle Drug Management
In most situations it’s easier to design a new drug than to update existing analytical methods and technology, noted Ganapathy Mohan, head of global CMC at Merck, Sharp and Dohme. Global approval of a…
Article
Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
Article
The Bullish Outlook for Biosimilars
Unique to the US, FDA will designate these follow-on biologics as either ‘biosimilar’ or ‘interchangeable biosimilar’ based on the level of evidence submitted. While there is still plenty of uncertain…