Search results for " biotherapeutics" in Articles / App Notes
Article
Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com
Leveraging automation and a step-by-step approach are keys to success.
By Cynthia A. Challener
Cell lines determine the performanc…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Despite their success, the adoption of biotherapeutics is marred by issues around affordability as well as risks associated to the challenges in assessment of their safety and efficacy arising from th…
Article
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
Article
CMOs Concerned With Cost of Single-Use Equipment
Suppliers indicate prices for single-use equipment are likely to increase.
By Eric Langer
Contract manufacturing organizations (CMOs) have been enthusiastic adopters of single-use technologi…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
Better process development is creating industry benchmarks for bioprocessing.
By Eric Langer
Biomanufacturing efficiency is on everyone’s minds, being the single most important area of focus…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
In addition to high cell density mammalian expression, expanded utilization of other expression systems such as microbial and yeast will support these newer biotherapeutics (BioTx). The diversity of B…
Article
Updating Viral Clearance for New Biologic Modalities
Many of these new and evolving biotherapeutics use viruses or virus-related approaches in their manufacturing processes.
Clearance challenges
The challenge of demonstrating viral clearance in …
Article
Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Surface plasmon resonance (SPR) has become a go-to tool for biotherapeutic characterization, and most approved antibody therapeutics have passed through a Biacore SPR system.
Stay up-to-date wit…
Article
Continuous Processing for the Production of Biopharmaceuticals
Perfusion technology has been successfully used for the production of biotherapeutics for more than a decade. In the past few years, researchers have worked toward making various downstream unit opera…
Article
Are You in Control of the Quality of Your mAbs?
Better biotherapeutic characterization for improved quality control
At the recent WCBP conference in Washington, D.C., Dr. Stuart Knowling from Antibody Analytics presented how the latest innovati…