Biopharmaceutical Analysis

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

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

Specification limits should be set early in drug development and refined in later phases as data becomes available.

Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.

Investment at SGS’s Mississauga, Canada facility provides for analysis of molecular interactions in real time.

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

The agency published guidance on data integrity as it is relates to CGMP compliance.

The authors investigate the sufficiency of high-temperature short-time treatment in inactivate mouse minute virus contamination.

The author describes common components of a relative potency bioassay and provides a framework for assay development, calculation, and control.

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

A $1.1-million NSF grant awarded to Advanced Polymer Monitoring Technologies will be used for the development of a characterization technology for monitoring aggregation in biopharmaceuticals.

The ready-to-use assays are specifically designed for companies looking to characterize their biosimilar products in the pipeline.

A new study concluded although some mAb products have heterogeneous variants, these charge variants are associated with similar potency and pharmacodynamic profiles as originator molecules.

The company will showcase workflow solutions for sample prep and data analysis.

The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.

The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.

Collaborative efforts are underway between suppliers and drug manufacturers to address raw material variability.

The advanced capillary electrophoresis system, Maurice, from ProteinSimple is used for the quantitative analysis of identity, purity, and heterogeneity profiles of biopharmaceuticals.

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

Understanding of the risks associated with FMEA is crucial in lot release testing.

The recognition that microbial artifacts are capable of modulating the mammalian immune system is an emerging view of biologic drug contamination control testing.

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.