Analytics

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.

Mass Spec Sheds New Light on Biologics Drug Development

Silvia Rocchi is a junior researcher in the E&L and Process Troubleshooting Lab, Protein Chemistry Dept. PADB P, Merck Serono.

Gabriella Angiuoni is QC Market & LC M Unit HeadâGlobal Manufacturing & Supply, Merck Serono.

Irene Cecchini is lab manager in the E&L and Process Troubleshooting Lab, Protein Chemistry Dept. PADB P, Merck Serono.

Daniele Mastroianni is a junior researcher in the E&L and Process Troubleshooting Lab, Protein Chemistry Dept. PADB P, Merck Serono

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

Evaluating E&L Studies for Single-Use Systems

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

Reproducibility Project only Partially Able to Validate Findings of Prominent Cancer Studies

Niels VÃ¦ver Hartvig, PhD, is a principal specialist, at Novo Nordisk A/S, SmÃ¸rmosevej.

Liselotte Kamper is a chemist, at Novo Nordisk A/S,SmÃ¸rmosevej 17-19, DK-2880 BagsvÃ¦rd, Denmark.

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.

A Statistical Decision System for Out-of-Trend Evaluation

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

Analytical Method Validation Using QbD and QRM

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

Application of QbD and QRM to Analytical Method Validation

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

Forced Degradation Studies for Biopharmaceuticals

Joanne Ratcliff, PhD, is communications project manager, Laboratory Weighing, Mettler Toledo GmbH, Joanne.Ratcliff@mt.com.

A program for calibration and routine testing of weighing instruments ensures accurate results.

Understanding Measurement Uncertainty in Weighing

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Analytical Method Development