Search results for " comparability"
Article
ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance
Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.
By Feliza…
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Modeling and miniaturization were two key take-home messages from the 4th High Throughput Process Development (HTPD) conference organized in October 2017 in Toledo, Spain. The conference brought tog…
Article
Evaluation of HEK293 Cell Growth and Adenovirus Productivity in HyClone™ CDM4HEK293 Medium
Human embryonic kidney 293 (HEK293) cells are widely used in production of recombinant viruses and proteins because of their stable growth, high transfection level, and ability to produce high viral t…
Poster
A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
mAb production using a Protein A capture step has followed a highly successful synergistic path the last 30 years. There are, however, remaining challenges.
• The increased upstream titers in mA…
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…
Poster
Impact of sporicidal agent on MabSelect SuRe™ protein A resin lifetime
Bacterial endospore contamination constitutes a challenge in bioproduction due to their resistance to high concentrations of NaOH, commonly used in sanitization procedures. Hence, there is an intere…
Poster
Case Study: Improve Process Economy by Cycling of Prepacked Chromatography Columns
The use of disposable technologies in downstream processing has increased significantly over the last years, as they reduce the need for time-consuming cleaning and cleaning validation operations as…
Article
Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
Single‑use (SU) systems have great potential in antibody‑drug conjugates (ADC) manufacturing. The use of organic solvents in the ADC process might , however, raise questions about potential leac…