Analytics

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

The shift toward personalized medicines poses new challenges in cleanroom protocols.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Michael Franco, global sales director at PSG Biotech, spoke with the PharmTech Group at INTERPHEX 2025 about recent advancements in pharmaceutical flow sensor technology.

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

The company now performs product-sterility testing through rapid microbiological methods at two laboratory sites in the United States and one in Germany.

Xiao-Yan Cai, PhD, shares insights into her leadership style, the importance of motivation in the workplace, and how she balances repetition with innovation, discussing how hobbies and resilience uniquely shape her professional approach, emphasizing the value of perseverance and preparation in both science and life.

Developers save money and time while accessing expertise.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

The launch of Roche's cobas mass spectrometry solution will bring fully automated mass spec analysis to the clinical lab.

Automation technologies provide real potential to improve responsiveness and decision-making in drug development.

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.

Located in German, Italy, and Lithuania, the new European facilities will specialize in drug discovery and R&D services.

Avantor's newly launched expanded Innovation Center in Bridgewater, NJ, is designed for integrated workflows and features purpose-built collaboration spaces.

Capturing and curating R&D data are crucial to realizing the full value of advanced analytics.

The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes of 100 mL–1000 mL.

The company will be expanding its quality control testing capabilities at its San Diego, Calif. biologics development and manufacturing site.

Collecting and curating R&D data are increasingly crucial tasks for achieving the full benefits of advanced analytics.

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

The best strategy is to use a combination of complementary methods.

The Almac Group is planning a £11 million (US$14.7 million) investment to expand the company’s existing analytical laboratories.

Sartorius' new Vivaflow SU tangential flow filtration cassette offers better flexibility in lab workflows and is designed to be more user-friendly.