Analytics

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

The author discusses analytical techniques for cleaning and disinfection, clean room operation, packaging component preparation, water-for-injection production, sterile product preparation, and aseptic filling, stoppering, and sealing.

Ensuring quality, sterility, and regulatory compliance are essential when choosing analytical methods.

The author presents lessons from the front lines of oncology, rare disease, and cell and gene therapy submissions.

Quality, stability, sustainability, and the increased and thoughtful integration of artificial intelligence are foremost in the minds of those on the leading edge of testing trends.

Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss method validation of biomarker bioanalysis.

Pharmaceutical Technology® spoke with Dr. Mark Arnold, owner and principal, Bioanalytical Solution Integration, ahead of AAPS PharmSci 360 to find out how bioanalysis enhances bio/pharmaceutical drug development.

Pharmaceutical Technology® spoke with Steve Lowes, senior director of Scientific Affairs at IQVIA Laboratories, ahead of AAPS PharmSci 360 to discuss how LC–MS is used in bioanalysis.

Long Yuan, PhD, director of the Department of Drug Metabolism and Pharmacokinetics at Biogen, explains how artificial intelligence, machine learning, and large language models are used in performing bioanalysis.

Artificial intelligence and machine learning are anticipated to boost success rates.

Artificial intelligence, machine learning, and novel instruments are helping drug developers evaluate complex data from bioanalytical studies.

In the conclusion of this three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.

In this continuation of a three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.

Advances in digital technologies offer effective data handling for bio/pharma manufacturing.

In a three-part series, the author explores the potential use of agentic AI in pharmaceutical R&D.

Bothe data integrity and quality of data are critical for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

The laboratory services provider is responding to growing demand for packaging and microbiological testing by expanding its laboratory space at its Wiesbaden, Germany, facility.

Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost compliance and diversification and seeking stable trade and R&D support.

The scaled adoption of cell and gene therapies demands a new era of agile, precise, and efficient quality control methods. Manufacturers and diagnostic partners must collaborate to create innovative, compliant testing strategies that preserve product integrity, meet tight timelines, and deliver life-saving treatments faster.

The company presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios at this year’s AAIC.

Help us get a better picture of how new tariffs and trade policy have impacted you and your organization.

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.