Search results for " comparability"
Poster
Evaluation of Protein A resin lifetime during extensive use (overloading) in continuous chromatography mode
In recent years, continuous chromatography has emerged as an alternative to batch operations to improve productivity or increase resin capacity utilization of chromatography purification processes. …
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Poster
Heating-cooling and liquid-liquid mixing characterization at a range of volumes
In a biopharmaceutical plant, more that 50% of the operation is mixing or hydration. Single-use mixers have been used in the past two decades in biopharmaceutical plants to replace the use of stainl…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
Article
Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
A Platform Approach to Purification of Antibody Fragments
Antibody fragments constitute a promising class of biopharmaceutical products. As compared with full length antibodies, their fragments have unique properties that make them favorable for certain th…
Poster
Validation of Cytodex™ Gamma microcarrier-based virus production in single-use bioreactor systems
A majority of cell lines commonly used for viral vaccine production are anchorage-dependent and require expansion on solid surfaces. Here, we describe different approaches for the cultivation of Ver…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
Article
Overcoming Buffer Challenges With In-Line Conditioning
Preparation and storage of the large number of buffers required for biopharmaceutical production can be a challenge, particularly in large production scale. In this application note, we show how in-…