Search results for " control" in Articles / App Notes
Article
State of Quality and Compliance in the Biopharmaceutical Industry
QUALITY IMPROVEMENT INITIATIVES
PAT, QbD, Quality, and cGMPs for the 21st Century are meant to provide increased understanding, control, and reliability of manufacturing processes, as well as c…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
With expanding demand for good-quality healthcare comes the challenge of controlling healthcare expenditures (1). The goals behind the safe and regulated introduction of biosimilars into the market in…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
The system air sensor controlled sample volumes processed across all inlets. Water from a hydro purification system was used for rinsing, water flux test, flush, and diafiltration steps. Water was use…
Article
Quality Considerations for Using AI in Bio/Pharma
Schniepp, distinguished fellow at Regulatory Compliance Associates, stresses that a robust quality management system and document control are necessary when adding AI to a process. “I also worry about…
Article
Moving Biosimilars Forward in a Hesitant Market
“As mentioned earlier, [companies] have to provide much more CMC [chemistry, manufacturing, and controls] data for biosimilars compared to the innovator, and that takes time. [Companies] have to estab…
Article
Bracing for a Future Wave of Advanced Therapies
In preparing for the future, ARM and FDA will be looking at streamlining CGT development and
manufacturing, collaborating on complex chemistry, manufacturing, and controls issues, improving soc…
Article
Report from the 6th International HTPD Conference
Further studies will focus on feedback controls, but will also evaluate similar nanosensors for other applications, such as oxygen uptake measurements in cells during culture.
An insightful pan…
Article
Trace metals getting you down? Learn what’s really in your cell culture media
So, how can you be sure these impurities are controlled?
Trust the raw material characterization program at Cytiva. We designed it to give insight into the types and quantities of impurities pr…
Article
A Look into Biologic Scale-Up Strategies
To maximize cell-culture output, strategy is required that takes into consideration factors such as cell culture media, environmental monitoring, and process controls. Yet, despite decades of process …
Article
Accelerating CMC - The future of process development is in silico
Simulation for in silico process development is becoming a viable option to reduce the time needed for chemicals, manufacturing, and control (CMC) activities and increase process understanding. Advanc…