Analytical Methods Articles - BioPharm International

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Analytical Methods Articles

Straightforward Guidance

May 1, 2008

In the context of process validation, the confirmation of a belief must be checked repeatedly, throughout the product lifecycle.

Evaluation of Dendritic Cell Products Generated for Human Therapy and Immune Monitoring

March 1, 2008

Emerging therapies pose challenges for standardizing QC.

Strategies for Validation Extensions

February 2, 2008

It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.

Formal Method Validation

February 2, 2008

The development and optimization process can improve a method, but validation does not. Validation is the final proof that regulations and expectations are met.

Analytical Method Maintenance

February 2, 2008

Several steps can be taken to maintain test method suitability after the formal completion of the analytical method validation studies,

Analytical Method Development and Optimization

February 2, 2008

Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps.

Presenting Data Effectively

February 1, 2008

The key to a good graphical presentation is to select the method that best fits the data.

The Role of Analytical Science in the Debate over Biosimilars

February 1, 2008

Both innovator and generics companies are using analytics to support comparability arguments.

Extractables and Leachables Study Approach for Disposable Materials Used in Bioprocessing

February 1, 2008

Two case studies illustrate a systematic approach.

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