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

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

Articles

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.

Pall Introduces Acrodisc Syringe Filters with Universal, Water-Wettable PTFE Membranes

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Tosoh Bioscience Introduces TSKgel UP-SW Aggregate UHPLC/HPLC Columns

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

The Importance of Partnering for Bioanalytical Studies

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

Bio-Rad Launches Anti-Certolizumab Pegol Antibodies

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

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests. 

Building Better Bioassays

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

Shaping IR Spectroscopy into a Powerful Tool for Biopharma Characterizations

The acquisition will expand Nexelis’ immunology testing expertise.

Nexelis to Acquire ImmunXperts, an Immunogenicity and Immune-Oncology Testing Lab

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Building Data Quality in Generates Quality Data Out

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

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

Bovine Heparin Meets Acceptable Impurity Levels

Analytical solutions are improving for raw material testing, process development, drug product release, and more.

Biopharma Analysis Benefits from New Technology and Methods

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.

How Advanced Mass Spectrometry Technologies and Workflows are Delivering Comprehensive Protein Characterization

GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.

GE Healthcare and ASLS Collaborate on Equipment for 3D Printed, Vascularized Tissue

Ensuring that viral vectors are free of viral contaminants requires a focus on prevention and control.

Biopharmaceutical Analysis

Method Transfer Across Global Sites

Risky Business: Assessing Protein Aggregation