Search results for " cell" in Articles / App Notes
Article
N-Glycan Analysis of Biotherapeutic Proteins
For example, arguably the most common N-glycan structure present on mAbs made in Chinese hamster ovary (CHO) cells is G0F: asialo-, agalacto-, biantennary complex N-glycan, core-substituted with fucos…
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Being Thorough When Transferring Technology
Significant increases in cell mass have led to limitations with both technologies. Next-generation harvest technologies, including flocculation with cell settling and microfiltration, are being implem…
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Managing Biomanufacturing Capacity Expectations
According to numbers from the 2016 BioPlan report (1), approximately 59% of respondents used at least some outsourced capacity for mammalian cell culture, 55% used outsourcing for microbial fermentati…
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Improving PAT for Biologics
Implementing PAT for bioprocesses presents unique challenges given the greater complexity of cell-culture and fermentation processes, the variability of raw materials (particularly living organisms), …
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Application of Quality by Design to Viral Safety
QbD in the Viral Safety of Raw Materials
A wide variety of biological raw materials can be used in a biopharmaceutical process, ranging from production cells to buffer components to excipients. Th…
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Challenges of Protein Aggregation During Purification
While most aggregates are formed during upstream operations, and the risk for aggregate formation at the cellular level has increased as titers have increased, if unsuitable conditions are selected fo…
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Updating Viral Clearance for New Biologic Modalities
Because viruses are typically smaller than downstream impurities such as host cell proteins (HCPs) and other extracellular debris, they require meticulous filtration, even in more established processe…
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Scalable Viral Vector Manufacturing
What are the main reasons for this rapid increase in viral vector manufacturing?
Viral vector platforms emerging at the crossroads of cell, gene therapy, and vaccines are becoming a promising ar…
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Real Time Continuous Microbiological Monitoring
LIF is extremely sensitive, with a limit of detection down to one microbial cell.
Real-time microbial monitoring using LIF
The use of Trypticase Soy Agar (TSA), also known as Tryptone Soya Aga…
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GMP Challenges for Advanced Therapy Medicinal Products
By Sean Milmo
A consultation period on GMP guidelines (1) in the European Union, specifically for advanced therapy medicinal products (ATMPs), comprising gene- and cell-therapy products and tissue-…