Articles on analytical & statistical methods, process analytical technology - BioPharm International

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Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle

March 1, 2014

This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.

Defining Quality Metrics is No Easy Task

February 1, 2014

ISPE and PDA take on the challenge of recommending quality metrics.

Determining Criticality—Process Parameters and Quality Attributes Part II; Design of Experiments and Data-Driven Criticality

January 1, 2014

Criticality is used as a risk-based tool to drive control strategies.

Metrics Sought to Ensure Drug Quality

January 1, 2014

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

Progress in the Prediction of Protein Aggregation

January 1, 2014

Techniques to enable the design and formulation of stable, protein-based therapeutics.

Understanding and Modeling Product and Process Variation

December 1, 2013

Variation understanding and modeling is a core component of modern drug development.

Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum

December 1, 2013

Criticality is used as a risk-based tool to drive control strategies.

Thermal Protection for Control-Room-Temperature Products

November 1, 2013

The authors discuss how to develop a cost-effective thermally protective packaging system.

Metacomplex Formation and Binding Affinity of Multivalent Binding Partners

November 1, 2013

A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.

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