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?

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 

Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

Sai Life Sciences’ Screening Capabilities Enhanced with Expanded Cellular Analysis Platforms

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

Aigenpulse’s Data Analysis Suite Automates Flow Cytometry

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

Thermo Fisher and CROs Expand Access to Cryo-EM

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

Polyplus-transfection Launches Residual Test for Transfection Reagents 

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

MilliporeSigma Invests $20 Million in New Switzerland Laboratory

Benton Cartledge is associate research scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Jason Carmichael is assistant scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Nathan Haag is a scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Eric Hansen is a scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Travis Lato is an assistant scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.

Predicting Extractables and Leachables from Container Stoppers

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.


Keeping Aggregation Under Control

Editor of Pharmaceutical Technology Europe

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.


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