Search results for " techniques"
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…
Article
Affinity Chromatography Handbook in 3 Volumes
Affinity chromatography (AC) separates proteins on the basis of a reversible interaction between a protein (or group of proteins) and a specific ligand coupled to a chromatography matrix. The techni…
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
Affinity chromatography Handbook: Vol. 2 Tagged Proteins
The use of recombinant proteins has increased greatly in recent years, as has the wealth of techniques and products used for their expression and purification. The advantages of using a protein/peptid…
Article
Affinity Chromatography Handbook: Vol. 1 Antibodies
The diversity of the antibody-antigen interaction and our ability to manipulate the characteristics of the interaction has created many uses for antibodies and antibody fragments, both for immunoche…