Biopharmaceutical Analysis

FDA talks about the changing scope of regulatory science.

What the industry's future holds and what needs to be done to get there.

NIBRT's Ray O'Connor provides an overview of aseptic processing.

Preparation of biological samples for chromatographic analyses.

NIBRT's Pauline Rudd on what to expect when performing glycan analysis.

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

NIBRT's Jayne Telford provides an overview of biopharmaceutical analytics and their accompanying qualification and validation steps.

A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.

Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility.

The complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.

USP optimizes identification tests and impurities procedures.

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

MIT survey results address product and site characteristics that statistically correlate with quality performance.

Using a competency-based approach to effectively train biopharmaceutical industry staff.

The authors describe a simple method to remove endotoxins from highly viscous formulations.

Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times.

In HDX studies, data are produced across multiple time points, multiple species, and with replicates.

The authors review the various analytical methods that can enable use of PAT.

Current expectations in bioprocessing and a framework for using NMR to enhance a QbD approach.

Members from an ASQ working group provide analytical methods to enable PAT.

Unnecessary analytical testing can lead to unnecessary costs.

Cell-line specific complex media supplements combine chemically defined media additives into a single supplement.

The authors discuss a new, rapid immunoassay for the detection of biomarkers.

Future sponsor-contract provider relationships will require more integration.

Rather than seeking a single indication for one large group, the orphan-drug approach segments the market for a drug more minutely.