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.

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Nelson Labs Launches Rapid Sterility Testing, Cutting Incubation Times

By Patrick Lavery

March 4th 2025

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

Inspiration Over Desperation: Accurant Biotech CEO Talks Leadership, Innovation, and Motivation

By Patrick Lavery

March 4th 2025

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.

Monitoring and course correction. Keep the process under observation and control. Calibration. | Image credit: ©Andrii Yalanskyi – Stock.Adobe.com

Outsourcing Analytics for Process Monitoring and Optimization

By Cynthia A. Challener

February 5th 2025

Developers save money and time while accessing expertise.

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Specification Equivalence—A Practical Approach

By Joseph A. Albanese
Gail Reed

Yelena Ionova
J. Mark Wiggins

December 30th 2024

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.

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

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