Search results for " system" in Articles / App Notes
Article
High-Throughput Process Development in an Historical Environment
…uid handling, plate set-up, incubation, assay set-up, and readings were contained within one robotic system. Essentially everything was automated to reduce variations as well as the workload while in…
Article
Application of Quality by Design to Viral Safety
…uidelines, Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
A QbD approach to drug development starts with the definition of critical quality attr…
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Challenges of Protein Aggregation During Purification
It is very early days, but we are looking forward to, in the foreseeable future, finding good solutions to cell line and expression system construction that will also help the purification process,” s…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The risk-assessment team first compiles a list of all the quality attributes of the product and systematically evaluates each attribute with regards to two factors: impact and uncertainty.
For im…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
The array was analyzed by ViiA 7 real-time PCR system (Life Technologies). The raw CT values were further analyzed by free web-based RT2 profiler PCR array data analysis version 3.5 (Qiagen). The rati…
Article
Q&As with Industry Leaders
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Adopting Single-Use Systems
Parrish Galliher, Chief Technology Officer Upstream at Cytiva
…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
mAbs are also extremely costly, and biologic versions are needed to maintain functioning healthcare systems, according to Theodor Dingermann, a professor and director of the Department of Pharmaceutic…
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Q&A with Industry Leaders: Rita Peters
This trend continued at Interphex 2014 with the introduction of equipment and systems targeting biologics manufacturing.
In other developments, mergers, acquisitions, and supplier consolidation co…
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Manufacturers Struggle with Breakthrough Drug Development
For the long term, FDA would like to see companies adopt innovative manufacturing strategies that can accelerate quality production, such as continuous manufacturing systems. Agency officials note tha…
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Design of Experiments for Analytical Method Development and Validation
A systematic approach for using DOE for analytical method development and validation is discussed in this paper and was written in line with the International Conference of Harmonization (ICH) Q2(R1),…