Search results for " Biopharm"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…ng to apply quality-by-design (QbD) methods and process analytical technology (PAT) underpinnings to biopharmaceutical development and manufacturing. As Jose Menezes, CEO of 4Tune Engineering, pointe…
Article
Supply Chain Challenges for Single-Use Systems
By Jennifer Markarian
The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative to or in combination with traditional stainless-steel equipment o…
Article
A Look into the Future of Biopharmaceutical Quality
To gain perspective on what the future holds for biopharmaceuticals and how the industry and regulators will address quality going forward, BioPharm International spoke with Anthony Newcombe, principa…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
This staged integration was very much the right approach since it was the first time the biopharmaceutical industry came together to collaborate in the pre-competitive space. It took some time for the…
Article
Automating Bioprocesses
By Jennifer Markarian
Both upstream and downstream biopharmaceutical processes have conventionally used stainless-steel equipment, but use of single-use systems (SUS) is becoming more established.…
Article
Automating Processes in Upstream Processing
By Susan Haigney
BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies, about automating processes in upstream processing.
BioP…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Market Trends
BioPharm: How is the market reacting to disposable chromatography solutions? Do you see growth? In what areas?
Royce and Lundström (Cytiva): The highly regulated biopharmaceutica…
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
Good Manufacturing Practices: Challenges with Compliance
Obstacles to compliance
BioPharm: What challenges do you see in complying with FDA’s CGMP regulations for biopharmaceutical manufacturing?
Smith (Catalent): In general, it is not difficult t…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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