Search results for "biopharm"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…g 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, pointed…
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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…
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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…
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Roadmap Leads to Innovative Biomanufacturing Strategies
BioPharm International interviewed three members of the steering committee that led the collaborative effort for the roadmap. Rajesh G. Beri is technical director R&D, biomanufacturing, Lonza; Morten …
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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.…
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Automating Processes in Upstream Processing
BioPharm: What specific challenges do companies face when automating upstream processes?
Marshall: New product introductions into existing facilities often require new equipment process capabiliti…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Shawn Knol/GETTY IMAGES
By: Randi Hernandez
BioPharm International, spoke to Fredrik Lundström, product manager, Cytiva; Jonathan Royce, bioprocess senior product manager of antibody affinity …
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The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…
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Good Manufacturing Practices: Challenges with Compliance
By Lauren Lavelle
BioPharm International spoke to Lauren Smith, senior director of quality, Catalent; Judy Cohen, vice-president of Quality and Regulatory at Lubrizol Life Science’s …
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Biosimilars and the impact of FDA guidance
BioPharm: Regarding biosimilars, there have been some changes in the US, with FDA setting requirements for analytics and for interchangeability…