Biopharmaceutical Analysis

Articles

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

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.


Stability Testing: The Crucial Development Step

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.

Eurofins DiscoverX Grants Bioassay Certification to VelaLabs

Editor of Pharmaceutical Technology Europe

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.


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