Search results for "biopharm"
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
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 …
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
BioPharm: What specific challenges do companies face when automating upstream processes?
Marshall: New product introductions into existing facilities often require new equipment process capabiliti…
Article
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 …
Article
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…
Article
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 …
Article
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…
Article
An Analytical Approach to Biosimilar Drug Development
Poon, Int J Biopharm Sci. online, DOI: 10.31021/ ijbs.201811091, May 24, 2018.
2. S. Berger, “How Analytical Technologies Support the Development of Biosimilar Drugs,” blog.waters.com/how-analyti…