Search results for " system"
Article
Labeling of Biosimilars
One way of doing this is seen to be, at least by the R&D sector, the introduction of a fully transparent labeling system.
References
1. EMA, Guidance on similar biological medicinal products contain…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Several companies are, however, developing technologies designed to overcome this problem, including high-throughput, high-performance, real-time, label-free analysis systems.
For Catalent, the ne…
Article
What Drove Biopharma Development in 2014?
…rticles, such as Highly efficient inoculum propagation in perfusion culture using WAVE Bioreactor™ systems.
This year, PDF will continue to report on industry trends that interest our readers. …
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
Thereby, you can be much more certain that if you make a change, the system will do what you predicted. Statistical models based on QbD sometimes fail. When you set up a statistical model based on DoE…
Article
New Era for Generic Drugs
This system moves away from OGD’s random assignment approach, established to avoid any appearance of favoring one application over another. Block reviews aim to reduce repeated efforts, promote inform…
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…
Article
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…
Article
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…