Search results for " biologics" in Articles / App Notes
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
Article
Framing Biopharma Success in 2016
The Center for Biologics Evaluation and Research (CBER) approved more than a dozen new biologics, vaccines, blood products, and diagnostics. These numbers, and types of drugs approved, indicate that t…
Article
GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
FDA’s focus on the need for updates is creating both opportunities and challenges for biologics manufacturers involved in the scale-up and transfer of production technologies. Single-use and modular t…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
Article
Biopharma Manufacturers Respond to Ebola Crisis
There has been broad interest in using tobacco and other plants to produce vaccines and biologics for multiple indications, and further testing of ZMapp provides an opportunity to evaluate biopharming…
Article
Challenges of Protein Aggregation During Purification
Focus on avoidance
Recently, there has been significant effort to prevent aggregation by carefully selecting and/or designing active biologics that are more resistant to aggregation and/or cell li…
Article
Q&A with Industry Leaders: Rita Peters
This trend continued at Interphex 2014 with the introduction of equipment and systems targeting biologics manufacturing.
In other developments, mergers, acquisitions, and supplier consolidation co…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…