Search results for " platform"
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Matthew Reuter, biotherapeutics business development with PerkinElmer, adds, “These novel nonradiometric homogenous no-wash platforms aid in assay transferability, reproducibility, scalability, and ov…
Article
Single-Domain Antibodies for Brain Targeting
They are, in general, soluble and can be produced as stable I targeting reagents for sensitive diagnostic platforms and nano-sensors (14-17). However, for in-vivo administration, immunogenicity concer…
Article
Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
An upside to this model is that many breakthrough biologics and innovative platforms are coming from small, start-up research companies, but their resources are limited. To get involved in development…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
…nes and may allow for ultimate regulatory approval of the company’s vaccines derived from a common platform.
Novavax has also produced new vaccine candidates for the prevention of SARS and the…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
In addition, continuous processing offers biotechnology companies increased flexibility—you can use the same platform for various types of therapeutic proteins. More flexible management of manufacturi…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
Furthermore, Protein A-based resins form the basis of almost all mAb-purification platforms as they are easy to use at both small and large scale with generic experimental protocols.
Increased …
Article
FDA Seeks Metrics to Define Drug Quality
An upgraded IT platform could compile information from all sources on sites and products to support a streamlined, risk-based inspection process. This initiative also could evaluate FDA performance, s…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Before an analytical method can be incorporated into a characterization platform or a quality control system, it must first demonstrate that the method is suitable for its intended purpose. Guidelines…
Article
Essentials in Quality Risk Management
An implementation plan with tools, training, and standard operating procedures are needed to build a low-risk development and manufacturing platform. Management involvement is needed to trigger risk-a…