Search results for " system" in Articles / App Notes
Article
A Bright Future for the Plasma Fractionation Industry
There is still a very bright future for the plasma fractionation industry. That was one of the conclusions reached when the 9th Plasma Product Biotechnology (PPB) meeting ended on the beautiful isla…
Article
Biomanufacturing Outsourcing Globalization Continues
As quality systems improve, these emerging regions will take on an increasingly important role on the global biopharma stage.
Recent headlines are testament to growth in China. For example, Cytiva…
Article
Ensuring the Quality of Biologicals
reference standard to demonstrate system suitability, and users are requested to establish their own in-house reference preparation for glycan analysis.
Biosimilars
A similar biological or bio…
Article
Vaccine Development and Production Challenges Manufacturers
Most at risk are infants too young to be vaccinated, children with illnesses that compromise their immune systems, and a broader population that looses immunity over time.
Combating Ebola
Meanwh…
Article
Tackling Analytical Method Development for ADCs
…onding ADC with a different architecture are also issues that must be considered when evaluating the systemic exposure of ADCs as part of drug pharmacodynamic and pharmacokinetic analyses, according …
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…