Search results for " cell"
Article
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), …
Article
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…
Article
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…
Article
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…
Article
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…
Poster
Adenovirus production in a single-use stirring tank bioreactor system
Anchorage-dependent cells cultured in roller bottles or cell factories are commonly used in these processes. However, scale-up using these techniques is complicated and limited by the surface availabl…
Article
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…
Article
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-…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Indeed, some processes, like a cell therapy process, will need to be performed in a sterile manner, so no level of bioburden would be acceptable. My view is that if a good risk assessment has been per…
Article
2014 Manufacturing Trends and Outlook
Protein aggregates, formulation issues, creating/cloning cell lines, regulatory issues, and analytics were mentioned by more than 25% of the respondents (see Table I).
Nucleic-acid based drugs.…