Search results for " containers" in Articles / App Notes

Article Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches. Oct 1, 2014 By: Jeff Fleming, Robin Payne BioPharm International …

Article Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability. Sep 2, 2014 By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…

Article Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design. Sep 1, 2014 By: Susan Haigney BioPharm International Volu…

Article Relationship Building at Top of Mind for Clients
Annual study shows technical expertise is not enough. Aug 1, 2014 By: Eric Langer BioPharm International Volume 27, Issue 8, pp. 12-14 Contract manufacturing organizations (CMOs) shou…

Article A Q&A With Phil Lester, co-organizer of the HTPD Conference
The 3rd HTPD Conference will take place this October, in Siena, Italy. Process Development Forum spoke with Phil Lester, one of the principal organizers of the conference. PDF: This is the third…

Article Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production. Smaller recombinant antibody fragments a…

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment. A critical quality attribute (CQA) has been defined as “a physical, chemical, …

Article Analyzing Proteins Using SEC, MALS, and UHPLC
Light scattering analysis combined with more rapid size exclusion chromatography improves protein characterization. The characterization of proteins involves identification of their complex …

Article Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…

Article Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals. The manufacture of biopharmaceuticals presents …

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