Biopharmaceutical Analysis

Accurate protein concentration results can be obtained using standard spectrophotometers and commercially available short path length absorption cells.

USP announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of Dec. 1, 2015.

Variation understanding and modeling is a core component of modern drug development.

A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.

The Waters ACQUITY QDa Detector is a mass detector designed to bring high-quality, mass spectral data to chromatographic separations.

A well-designed comparability study can demonstrate the performance and advantages that can be gained when adopting a new protocol.

The correlation between limulus amebocyte lysate (LAL) assay and rabbit pyrogen test (RPT) targeting recombinant human epidermal growth factor (rhEGF) as active molecule was assessed.

A simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics is described.

Review the importance of characterization studies during biosimilars development and related analytical methods.

Knowledge of product or process acceptance criterion is crucial in design space.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

Viruses in animal-derived starting materials could contaminate biopharmaceutical final product. A rigorous testing strategy and removal methods are reviewed.

The author discusses the need for stability analysis.

The authors provide common misconceptions and key concepts behind reliability engineering.

Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss special considerations for testing for extractables and leachables for both small molecule and biological drug development.

Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss the key elements of an effective testing program to identify extractables from materials and leachables in drug products.

Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Ferdinand Dabu, director of marketing at SGS live at Interphex 2013 about extractables and leachables. In this interview they discuss new analytical testing procedures and instruments that are facilitating the testing processes or improving results.

Editorial Director Rita Peters talks to with Ferdinand Dabu Director of Marketing at SGS live at Interphex

The author describes a method to avoid protein aggregation when using light scattering systems.

Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.

At Pittcon 2013, Bruker introduced a range of instruments and software updates including two LC-triple quadrupole (LC-TQ) mass spectrometers.

Rigaku Raman Technologies announced an updated version of the FirstGuard handheld Raman analyzer at Pittcon 2013.

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

Optimized freeze-drying cycles can offer scientific and business advantages.

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

NIBRT's Michael Lacey provides an overview of biopharmaceutical facility design and operation.

Project: transfer a manual concentration/diafiltration process for siRNA production.

FDA talks about the changing scope of regulatory science.