Biopharmaceutical Analysis

Jared Auclair is associate dean, Professional Programs and Graduate Affairs, and director, Biopharmaceutical Analysis Training Lab, Northeastern University.

Lori Stansberry is marketing manager, Pharma & BioPharma, Thermo Fisher Scientific.

Articles

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

Is Collaboration the Key to Accelerating Biotherapeutic Development?

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Clear understanding of what exactly the biomolecule entails is essential.

Using Protein Characterization to Support Regulatory Submissions

A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.

BioSkryb Discusses First Data Demonstrating Improved Accuracy in Single Cell Analyses

The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.

Expansion of APEIRON Biologics and Domainex Partnership will Advance Cancer Drug Discovery

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site. 

Charles River and PathoQuest Establish US Subsidiary for NGS-based Testing Lab 

Feliza Mirasol is the science editor for 

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Complex Modalities Require More Sensitive Adventitious Agent Testing

Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA. 

Samsung Biologics Incorporates Solentim’s Cell Line Development Technology into New R&D Center 

Mogrify’s new technology platform, EpiMOGRIFY, can predict cellular switches important for determining cell identity, cell maintenance, directed differentiation, and cell conversion.

New EpiMOGRIFY Technology Platform Offers Development Support for Allogeneic Cell Therapies

With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.

Novel Single-Cell Whole Genome Amplification Technology Made Commercially Available at ASHG 2020

Christopher Burgess is with Burgess Consultancy, "Rose Rae," The Lendings, Starforth Barnard Castle, Co. Durham, DL12 9AB UK.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Analytical Methods