Search results for " equipment"
Poster
Unlocking the potential for efficiency in downstream bioprocesses
It also shows how implementation of efficient process designs can overcome traditional downstream bottlenecks, such as time-consuming column packging, cleaning of equipment, and laborious buffer tank …
Article
Reporting Quality Metrics to FDA
For example, metrics will be different for a site that manufactures a large variety of products in multipurpose equipment in small numbers of batches, compared with a site that produces large volumes …
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Antibodies and their derivatives are increasingly important as biotherapeutics, precision diagnostics, and essential tools for biological research. Techniques to screen and characterize large number…
Article
Continuous Processing for the Production of Biopharmaceuticals
In addition to eliminating several hold steps, the advantages of this platform were realized in the form of increased process throughput and decreased equipment footprint.
Figure 2: Archi…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The absence of chemical reagents, surface modifications, or complex equipment, however, makes this technique an attractive alternative for laboratory scale cell detachment from t-flask-like culture de…
Article
Framing Biopharma Success in 2016
Investing in infrastructure
Attractive credit terms in recent years prompted some biopharma manufacturers to invest in facilities and equipment. Encouraging companies to make capital improvements …
Poster
One-step seed culture expansion from one vial of high-density cell bank to 2000 L production bioreactor
This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes.
Article
The Metrics of Quality Culture
When establishing site metrics, the company could look at inspection history including internal audit findings and maintenance history such as equipment age versus defect-failure rates. People metrics…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
BioPharm: Does the use of single-use systems (SUS) and/or equipment present any specific challenges or considerations when performing a risk assessment?
AstraZeneca: The use of SUS removes some of…
Article
Robust Optimization, Simulation, and Effective Design Space
A good understanding of the process or equipment capability will aid the developer in building the simulation (see Figure 4). Normal, truncated, and non-normal distributions are used to inject the sim…