Search results for "bioprocess"
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Continued Process Verification for Biopharma Manufacturing
CMC Biotech Working Group,A-Mab: a Case Study in Bioprocess Development(Oct. 30, 2009), accessed Sept. 16, 2014.
4. From presentation at 10th APIC/CEFIC meeting, “FDA’s Quality Initiatives—An Upda…
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Challenges and Trends in Biopharma Facility Design
Kranjac (Cytiva): As bioprocess infrastructure transitions from large facilities, which traditionally produce only one biotherapeutic, biopharmaceutical companies are increasingly seeking flexibility …
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Pharma Investments Reflect Key Industry Trends
“While demand has increased for biopharmaceuticals, it has not kept pace with the 10-fold increase in productivity,” states Günter Jagschies, senior director of strategic customer relations for BioPro…
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Relationship Building at Top of Mind for Clients
…g that stress onto their CMOs, potentially due to a lack of experienced staff dealing with CMOs and bioprocessing outsourcing.
Sponsors want CMOs to effectively handle tough issues
CMOs are bei…
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Single-Use and Continuous Processing Technologies Change Facility Design
About the Author
Günter Jagschies, PhD, is senior director for Strategic Customer Relations, BioProcess at Cytiva.
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Applying GMPs to the BioPharma Supply Chain
They need to understand how variability in raw material quality can have a significant downstream impact on bioprocessing capability and biopharmaceutical product safety.
Traceability, visibility,…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
CMC Biotech Working Group, A-Mab: A Case Study in Bioprocess Development. October 2009, accessed June 5, 2014.
10. S. Kozlowski, “Implementation Activities for QbD: FDA Office of Biotechnology Pro…
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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…
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Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
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Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…