Analytical Method Development

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesize polymers to accelerate antimicrobial activity screening.

Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

A new book by Robert Thomas, principal consultant at Scientific Solutions, provides a training tool for novices and inexperienced users of plasma spectrochemistry as well as for supervisors and senior management who want to better understand the analytical issues. Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb.

A new scientific publication examines analytical processes for the emerging legal cannabis industry.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.

Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Forced degradation studies can identify stability problems for drug substance and drug products.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.