Outsourcing

Articles

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

Integrated First-in-Human Service Package for Poorly Soluble Small Molecules

Cambrex’s expanded quality control laboratory supports generic API development.

QC Lab Extends Capabilities at Cambrex’s Milan Facility

The companies will merge to offer a broader range of analytical data packages and regulatory support for biopharmaceuticals.

Protagen Protein Services, BioAnalytix Merge into CRO

The partnership will enable the Applied Process Company (APC) and the National Institute for Bioprocessing Research & Training (NIBRT) to provide increased access to R&D and analytical services.

APC, NIBRT Partner to Improve Access to Biopharmaceutical Services

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Locking Fraudulent Materials Out of the Supply Chain

The expansion includes a new R&D laboratory and the installation of a 12,000-liter reactor at one of the company’s manufacturing facilities on its Paullo site in Milan, Italy.

Cambrex Completes Expansion and Manufacturing Capability Upgrades in Milan

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.

Determination of Sodium Chloride in Yeast Extract by Ion Chromatography

Luke Deters is director Biologics at Catalent Pharma Solutions, Kansas City, Missouri, USA.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.


Quantification and Characterization of Polysorbate-80 in Protein Formulations

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.


Key Considerations in Stability Testing

Daniel N. Hayes is associate principal scientist at Cambrex High Point Analytical Research and Development.

Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.

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