Search results for " fundamentals" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Gowning Practices Provide Clues to cGMP Compliance
Because gowning is deeply integrated into a facility’s operation, many cGMP fundamentals are reflected in gowning implementation. These questions can be used to help conduct a simple, initial evaluati…
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Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
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Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
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Report from the 6th International HTPD Conference
Professor Martina Micheletti from University College London presented ‘Scale-down tools for rapid upstream process development: fundamentals and scaling approaches. Professor Micheletti presented a hi…
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Digitalized PD: Speeding up downstream process development
Mechanistic models enable the simulation of chromatography processes based on fundamental natural laws, such as fluid dynamics and thermodynamics. In silico simulations of chromatography proce…
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Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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e-Learning: what is quality by design (QbD)?
Key learnings:
- Fundamentals of the QbD concept
- How QbD fits within process development and process characterization
- Key aspects of QbD, such as the principle of design space and est…