Biopharmaceutical Analysis

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

Articles

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 raw materials used in the chemical synthesis of peptides.

Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations

USP evaluates quality attributes for synthetic peptides.

Control Strategies for Synthetic Therapeutic Peptide APIs&#151; Part I: Analytical Consideration

Xiaochun Yu, PhD, is a senior research scientist at the cGMP laboratory, PPD, Inc.

Steven Zdravkovic is a senior scientist at the cGMP laboratory, PPD, Inc.

Laurie Stockmeier is a scientist at the cGMP laboratory, PPD, Inc.

Heather Schmidt is an associate research scientist at the cGMP laboratory, PPD, Inc.

Don DeCou, PhD, is a senior research scientist at the cGMP laboratory, PPD, Inc.

Daniel Rude is a research scientist at the cGMP laboratory, PPD, Inc.

Robert Piccoli, PhD, is an associate research scientist at the cGMP laboratory, PPD, Inc.

Derek Wood is a laboratory manager at the cGMP laboratory, PPD, Inc.

Xiaoya Ding, PhD, is the director of scientific and technical affairs at the cGMP laboratory, PPD, Inc.

A systematic approach facilitates formulation component selection.

Biopharmaceutical Analysis: GC-MS