Analytical Methods Articles - BioPharm International


Analytical Methods Articles

Analytical Methods: A Statistical Perspective on the ICH Q2A and Q2B Guidelines for Validation of Analytical Methods

December 1, 2006

Vagueness in the ICH Q2A and Q2B guidelines necessitates effective protocol design and data analysis. For specificity (detection in the presence of interfering substances), the goal is statistical differences with meaningful implications on assay performance. Linearity (results directly proportional to concentration of analyte in the sample) is typically demonstrated via least squares regression. Accuracy (difference between measured and true values) usually is presented as a percent of nominal. Precision analysis is vital because it supports claims of accuracy and linearity. A well-designed experiment and statistically relevant methods will facilitate method validation in accordance with ICH guidelines.

Disposable Biopharmaceutical Processes–Myth or Reality?

November 2, 2006

Biopharmaceutical processes typically require a significant investment in equipment—often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy.

Downstream Processing: Improving Productivity in Downstream Processing

November 1, 2006

Increased resin stability can extend the number of cleaning cycles that can be performed in situ.

Specification Setting: Setting Acceptance Criteria from Statistics of the Data

November 1, 2006

This article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.

A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance

October 1, 2006

The first part of this article, published in the September 2006 issue, discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.

A Guide for Testing Biopharmaceuticals Part 1: General Strategies for Validation Extensions

September 1, 2006

Good risk management tools dictate how much assay performance characteristics can deviate from ideal.

Applying Process Analytical Technology to Biotech Unit Operations

August 1, 2006

Case studies were run to test Process Analytical Technology applications for protein refolding, diafiltration, and cation exchange chromatography. It is shown that it is feasible to design control schemes that rely on measurement of product quality attributes and thereby enable real-time decisions.

Final Word: Using Molecular Tools for Biopharmaceutical Quality Control and Plasmid DNA

July 1, 2006

For decades now, it has been said that "the process is the product" for biologics. Great care and consistency must be applied in their upstream manufacture—during fermentation, harvest, and early purification—to preserve their complex structure, which confers their activity and specificity. As the product moves to late-stage purification, however, the relative concentration of impurities and altered product forms is diminished. Also, the final dosage form of most large molecule biopharmaceuticals is the relatively simple liquid formulation of parenteral dosage form. In contrast, manufacturing the solid dosage forms common for small-molecule drugs involves more complex processes, such as mixing dry powders, granulation, manufacturing controlled-release matrices, and tableting.

Peak Shape Calibration Method Improves the Mass Accuracy of Mass Spectrometers

July 1, 2006

A novel calibration approach was developed that not only calibrates the X-axis, but also calibrates the peak shape.



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