Search results for "validation" in Articles / App Notes
Article
Early Communication with Regulators is Essential for SMEs
“Quality documentation continues to be a problem area for many SMEs, particularly relating to manufacturing process validation, the setting of specifications, and stability data,” says the SME Office …
Article
2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
In addition, more cost-efficient cleaning procedures are necessary to extend the lifetime of chromatography resins and to reduce the cost for cleaning and validation. A team from Chugai Pharmaceutical…
Article
Trends in Downstream Bioprocessing
…ials
• Lack of single-use (disposable) options
• Cost of membranes
• Cleaning and validation costs
• Time for operations.
In addition, while many firms would like to avoid the hig…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
A typical biologic development route includes: preclinical discovery and validation of target; clinical development; drug approval, launch, and commercialization. During preclinical and early clinical…
Article
The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
The single-use system eliminates the hassle of time-consuming and costly steamin-place, clean-in-place, and cleaning validation procedures. The result is an efficient processing and rapid batch-to-ba…
Article
Essentials in Quality Risk Management
…imit generation, critical process parameters and control selection, and finally, method and process validation (see Figure 2). ICH Q6, Q8, Q9, Q10, and Q11 detail the pharmaceutical development proce…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Clinton Weber is associate director of BioProcess Sciences, Ashok Kumar is principal scientist, Lisa Joslin is process validation manager, and Roland Ashton, James Schmid, and Michael Larson are devel…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The benefits of a two-column purification process include reduced capital, footprint, quality systems, validation, cleaning, development costs, solutions, and water consumption. The HTS method has als…