Search results for " hybrid"
Article
Labeling of Biosimilars
The current position on labeling by EMA is based on a 2012 guideline (5) covering generic medicines, hybrids, and biosimilars. This guideline states that, as with generic drugs, the biosimilar’s summa…
Article
Trends in Single-use Bioreactors
It’s generally easier to interconnect single-use products when and where desired as opposed to trying to hybridize with existing stationary steel systems.
Galliher (Cytiva): It depends. On the one…
Article
2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
Article
Paring Down Impurities in Downstream Processing
Bioreactors to house these systems might be stirred-tank, air-lift, fixed-bed, hollow-fiber perfusion, or suspension, perhaps even hybrid combinations thereof. All of these lead to a gamut of membrane…
Article
Benefits of DoE vs mechanistic modeling
You will learn that, quite often, these methods work hand in hand in a hybrid setup to improve your process development!
Watch this webinar on-demand
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Ribault does add, though, that if a hybrid approach is used, all aspects including equipment and sampling, need to be taken into account to ensure there are no bottlenecks that can slow down the chang…
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Molecular dynamics simulations increase our scientific understanding, while a hybrid of mechanistic and statistic models allows to better cope with uncertainty, noise and trends over production cycles…
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Use of continuous bioprocessing is likely to further increase with the arrival of more hybrid systems that use bolt-on-type technology, which retrofit components unit operations for existing systems. …
Article
Methods Accelerate Biosimilar Analysis
The new generation of mass spectrometers, including time-of-flight (ToF) instruments, as well as hybrid systems such as quadrupole (Q)–ToF, ion trap–ToF or ToF–ToF, and orbital ion trap mass spectrome…