Analytical Method Development

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

A program for calibration and routine testing of weighing instruments ensures accurate results.

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.

The countdown has begun for one of the biggest trade shows for the process industry.

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

The rapid testing of biologic raw materials can lead to greater efficiency.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

Ligand-binding assays are fundamental to characterizing biosimilars.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

Methods must be suitable at each development phase, robust, and effective on multiple platforms.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.

The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial

FDA updates guidance to reflect advances in technology.

Michael Rooney, director, bioanalytical development at Jazz Pharmaceuticals, provides an overview of a life cycle strategy for analytical methods development, the need for standards and guidance documents, and therole Quality by Design can play in method development.

Now at a practical size and price, terahertz spectroscopy is advancing as a nondestructive method of analysis for solid forms and tablet coatings.

New capillary-based imaging techniques for protein charge variant analysis are reducing development and start-up times for protein-based therapeutics.

Iterative and multiple incremental advances in particle-characterization technology are making a difference in pharmaceutical analysis applications.

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.

The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.

Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.

We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?