Search results for " cell" in Articles / App Notes
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.…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
The enzyme is expressed primarily by muscle cells and adipocytes and is central to the processing of circulating triglyceride-rich lipoproteins.
Glybera is a replication-deficient adeno-asso…
Article
Remote Monitoring and Big Data Advance Upstream Automation
“A single ambr15 experiment generates 48 samples daily, each requiring full analytics with the potential for the resulting data to impact cell culture feed decisions. Automating these activities would…
Article
Flexible Facilities for Viral Vector Manufacturing
While the initial project looked at a monoclonal antibody (mAb) facility, the team plans to extend the concept to cell and gene therapy production.
Cytiva has amassed expertise in modular design a…
Article
Tools and Processes for Mature and Emerging Therapies
While technology advances for more traditional biologic-based drugs such as monoclonal antibodies are evolutionary, the processing requirements for emerging cell therapies and gene therapies may requi…
Article
QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…
Article
Fusion Proteins Pose Manufacturability Challenges
Challener
Fusion proteins are engineered proteins that contain domains from different proteins that originate from different sources, such as a cell surface receptor or cytokine (i.e., interferon …
Article
Microbiological Testing: Time is of the Essence
“Occasionally the therapeutic molecule can have toxic effects on the detector cells that are used to detect viruses in in-vitro assays that comply with ICH Q5A (1) and related regulatory guidelines,” …
Article
Continuous Manufacturing: A Changing Processing Paradigm
In addition, writes Langer, “lag phases are eliminated because cell culture is always at or near peak efficiency” (1). Elimination of process collection and hold steps is a major benefit of continuous…