Search results for " techniques" in Articles / App Notes
Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
The bias is toward fed batch with membrane techniques being used to increase cell density. Reduced media pricing would shift the balance toward perfusion-based processes.
The situation in downstrea…
Article
Unifying Continuous Biomanufacturing Operations
Although these drugs only exploit continuous techniques upstream, experience with this type of process upstream may help to eventually inform end-to-end manufacturing solutions. As the concept of inte…
Article
Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
Extractable organic compounds and trace elements from the single‑use components were identified and semi‑quantitated with a complementary set of analytical techniques. The low levels of extractabl…
Article
Witnessing Major Growth in Next-Generation Antibodies
As mass spectrometry techniques have advanced in sensitivity over the years, researchers have the capability of pinpointing modifications to determine the location of conjugation sites for ADCs and en…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
Article
Managing Risk in Raw Material Sourcing
…, fishbone diagrams, and fault tree analysis, as well as hazards analysis and critical control point techniques, says Ohri. The company has established sites in the United States, Europe, and India, …
Article
Biosimilars to Drive Modern Manufacturing Approaches
These activities can help refine the manufacturing process, where incorporation of advanced techniques and quality-by-design approaches may facilitate “fingerprint”-like analysis of a biosimilar seeki…
Article
Establishing Acceptance Criteria for Analytical Methods
The following are techniques to demonstrate the method meets the minimum linear range of the method:
• Plot of the residuals and/or studentized residuals from a regression line
• No systematic…
Article
Modeling Bioreactor Performance
“Users must develop their own calculation sheets in programs such as Excel [Microsoft] or MatLab [Mathworks] based on known mathematical relationships and using first principles modeling techniques,” …
Article
Perfusion in the 21st Century
Currently, there is no perfusion device that can handle the working volumes typically used for high throughput techniques (1-200 mL). Industry efforts are underway to find alternative models that will…