Search results for " analyze"
Article
Platform Approach Speeds Process Development
Thousands of clones per project are analyzed using a robotic platform including cell sorting, automated single-cell deposition, and high-throughput analytics for product quantity and quality. The high…
Article
Aseptic Processing: Keeping it Safe
Filters, in particular, should be analyzed for removal of bacteria (such as challenge organism Brevundimonas diminuta) from the stream per ASTM 838-05, and investigators should be able to demonstrate …
Article
Breakthrough Drugs Raise Development and Production Challenges
…anagement plan, combined with clear analysis of what can be evaluated during review, and what can be analyzed later after approval.
Groskoph noted that successful launch of a breakthrough drug in…
Article
Robust Optimization, Simulation, and Effective Design Space
• Analyze and assess the data to establish appropriate ranges, including establishment of a design space if desired.”
The following are generally accepted key steps for building a process model an…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
According to Lockner, with AUC, the amount of method development needed is minimal, as biopharmaceuticals can often be analyzed in the formulation buffer as it exists in the vial. Because AUC can prov…
Article
Tackling Analytical Method Development for ADCs
Electrospray ionization (ESI)-MS, liquid chromatography (LC)-MS/MS, and matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) have been used extensively to analyze the DAR, free drug…
Article
The Bullish Outlook for Biosimilars
IMS analyzed the uptake of biosimilars across the EU and reported significant variation between countries as well as biosimilar classes (see Figure 1) (12). Such variation likely reflects local pricin…
Article
Fermentation for the Future
Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.
Jan 01, 2015
By Cynthia Challener, PhD
Microorganisms—bacteria and yeast—have b…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The films A and A’ were analyzed for content of oxidized TBPP. In addition, cell-culture medium were incubated in gamma irradiated containers built from the films A and A’. Chemical analysis results a…
Article
DoE Provides Benefits, but Preparation Is Necessary
…ts examined to a subset of approved parenteral excipients can reduce the amount of data that must be analyzed.
Training on data processing is also crucial, regardless of what approach is used. La…