Search results for " production" in Articles / App Notes
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sampling
Rinse sampling is commonly used to evaluate surface cleanliness of closed production equipment, hoses, and piping commonly cleaned by CIP systems (23–25). The advan…
Article
Managing Residual Impurities During Downstream Processing
Challener
Manufacture of protein and other biologic drug substances via cell culture or fermentation occurs with the natural, simultaneous production of other unwanted materials, particularly host-…
Article
Generating a Fully Processed Antibody
Ability to modulate ratios of protein expression
Different levels of protein expression are typically needed to maximize the production of a complex protein molecule. If a modifying enzyme is requ…
Article
Tools for Continuous Bioprocessing Development
Generally, production teams choose the platform that affords them the greatest control of the various process parameters. Without design rules for processes, this inevitably results in choosing platfo…
Article
Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
Article
Technology Innovations Improve Process Chromatography Performance
…ssing have not kept pace, says Nandu Deorkar, vice-president, research & development—Biopharma Production, Avantor.
“In downstream processing, the ultimate goal for biopharma manufacturers is to …
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Inconsistent access or inconsistent starting material quality can leave manufacturers shorthanded, increasing the risk of batch failure or missed production deadlines. With increased pressure on hospi…
Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
…
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…