Analytical Method Development

IQ Consortium representatives explore industry approaches for applying GMPs in early development.

Might European officials reverse their position on acceptable production methods?

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

Recent recalls, including that of American Regent?s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.

The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.

A roundtable moderated by Angie Drakulich.

The author examines the process of method development, with reference to ISO 13320:2009 and relevant monographs from the United States and European pharmacopoeias.

The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.

A method for determining sample size is finally getting some respect.

The author assesses the power and limitations of NIR chemical imaging and its future.

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.

Pharmaceutical Technology talked to drugmakers, equipment vendors, and service providers to learn more about the advantages and disadvantages of rapid microbial-detection methods.

Dr Martin Cockcroft, Operations Manager at Tepnel Pharmaceutical Services, an established business of Gen-Probe Inc., speaks about harmonized microbiology methods.

The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.

The first project report on FDA's Sentinel website, discusses the evaluation of existing methods for safety signal identification.

Development & Validation of an Inductively coupled Mass Spectrometric Method-ABC Labs Whitepaper

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs. This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).

Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a conference session, "Performing Analytical Method Validation Robustness for Regulatory Compliance," at Interphex on Thursday.

Argonne, IL (Nov. 9)-Researchers from Argonne National Laboratory?s Chemistry Division and Xradia have developed a novel X-ray microscopy technique that allows molecular observations of the reactivity of solid surfaces at the nanometer scale, including interfacial reactions such as ion adsorption and catalytic reactions.

AAPS, San Antonio (Oct. 31-The advantages of ultra-performance liquid chromatography over traditional high-performance liquid chromatographic were the center of the presentation, ?Strategies for Rapid Chromatographic Method Development from Preclinical to Phase 3,? by Charanjeet Jassal of Wyeth Pharmaceuticals.

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.

Outliers may provide useful information about the development and manufacturing process. Analysts use various statistical methods to evaluate outliers and to reduce their impact on the analysis. This article describes some of the more commonly used identification methods.

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.

Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.

"The better we understand the relationship between process parameters and product attributes, the better control we'll have over product quality," said Beth Fowler, PhD, during Tuesday?s session on process monitoring at the AAPS Annual Meeting.

Participants in a 2003 PhRMA workshop present the industry’s current thinking on developing analytical method equivalency, including the importance of sample selection, acceptance criteria, data evaluation, and documentation.

The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.

Detection and identification of different polymorphic forms is, therefore, important throughout the drug development and manufacturing process.