Standardized analytical method-transfer kits streamline method transfer and site certification.

Method Transfer Across Global Sites

Biologic modalities pose increasingly complex challenges.

Risky Business: Assessing Protein Aggregation

Topic

Articles

Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.

Dolomite Microfluidics Partners with MilliporeSigma for Microfluidic Device Kits 

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 

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Single-Use Sensors Increase Process Understanding

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

Complex Modalities Require More Sensitive Adventitious Agent Testing

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.

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Risky Business: Assessing Protein Aggregation Grows Increasingly Challenging

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

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

Pall’s 24-Well Filter Plate Performs Cell Clarification and Sterilization

The company recently launched its OmniTop Sample Tubes adjustable volume sampling system, a single-use system that allows for exact sampling.

Avantor OmniTop Sample Tubes Offers Adjustable Volume Sampling

The new filters extend column life and reduce contamination while simplifying sample preparation.

Biopharmaceutical Analysis

Method Transfer Across Global Sites

Risky Business: Assessing Protein Aggregation