Biopharmaceutical Analysis

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

Articles

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

Evaluating E&L Studies for Single-Use Systems

The Chinese facility was cited for data integrity violations.

Zhejiang Medicine Receives FDA Warning Letter

A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.

Analysis of Glycosylation in Biosimilars

Michiel E. Ultee, PhD, was Chief Scientific Officer at Laureate Pharma, Inc.

The authors present a review of the techniques commonly used for glycosylation analysis.

Implications of Cell Culture Conditions on Protein Glycosylation

Adeline Siew is science editor for BioPharm International.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

Drug Delivery Systems for Biopharmaceuticals

The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.

Quality by Design and Extractable and Leachable Testing

Michael Verlander is technical advisor at PolyPeptide Group.

Harold Rode is a consultant at Rode Biologics Consulting.

USP evaluates quality attributes for synthetic peptides.

Biopharmaceutical Analysis: Gas Chromatography