Quality Control/Quality Assurance (QA/QC)

This article explores the key challenges analytics and mass spectrometry solve within the biopharmaceutical industry.

The new technology can be used by analytical scientists working in a variety of industries including food and beverage, oil and gas, and more.

We provide a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and their impact on the analytical chemist in the pharmaceutical industry.

Manufacturing capillary gas chromatography (GC) columns is a very complex procedure, with many production factors to consider. In this LCGC Blog, Tony Taylor lists some of the vital components of the GC column-making process.

Waters Corporation has purchased Wyatt Technology, expanding both parties' reach in biopharmaceutical development and creating better healthcare technology for all.

If your decision making relies on analytical chemistry, then you want to be confident that the measurements are an accurate representation of the matrix that is being analyzed, and that they are of “publication” quality. But how can you know for sure if the analytical laboratory that you’ve selected is producing reliable data?

Qualification and calibration of high performance liquid chromatography (HPLC) chromatographs is a regulatory requirement, but how proscriptive should guidance be?

Everyone who is reading this column is interested in chromatography, and I want to shine a light on the industrial side of the application space.

As a result of the pharmaceutical cGMP for the 21st century and quality by design (QbD) initiatives championed by regulators, the biopharmaceutical industry has been looking for ways to introduce more automated and higher information content analyses into manufacturing, late-development, and quality control (QC). Mass spectrometry (MS-) based attribute monitoring assays have been proposed as key tools to provide the sensitivity, throughput, selectivity, and flexibility required for monitoring critical product and process attributes for biopharmaceutical production and release. Two analytical workflows, subunit multi-attribute monitoring (MAM) and peptide MAM, have emerged to dominate this discussion, and this article is intended to reflect on the active debates over the needs, challenges, and practical limitations for adopting MS-based attribute monitoring for late-development and QC.

Quantitative determination of the counterions associated with pharmaceutical salts is a mandatory requirement for quality control. While ion chromatography (IC) is the standard technique in most laboratories, capable of delivering excellent sensitivity, specificity and flexibility, there are other simpler and quicker analytical methodologies that may should be considered for this quality control application.

This fourth and last instalment in the “Separation Science in Drug Development” series provides an overview of modern practices of quality control in small-molecule drug development, including activities such as setting specifications, method validation and transfer, release and stability testing, and authoring chemistry, manufacturing, and controls (CMC) sections of regulatory filings.

Mass spectrometry (MS) is emerging as a critical tool in biopharmaceutical late stage development, manufacturing, and quality control (QC) environments. The rapid growth of biologics in development, the increasing demand for more robust analytical technologies to directly monitor the critical quality attributes (CQAs) of these new drugs, and longer term industry initiatives aimed at improving quality and productivity, such as quality by design (QbD) regulatory submissions and continuous manufacturing, are all fueling a greater need for mass monitoring with MS.

This fourth and last installment in the series of “Separation Science in Drug Development” provides an overview of modern practices of Quality Control in small molecule drug development including activities such as setting specifications, method validation/transfer, release and stability testing, and authoring CMC sections of regulatory filings.

A method specifically developed to measure the molar mass distribution (MMD) of polyolefins in a manufacturing plant laboratory has been developed. It is demonstrated that the total cycle time, including the sample dissolution step, can be reduced to around 30 min, well in line with the process control requirements.

To translate the enormous potential of MS into meaningful, actionable, and safe test results in the specific setting of a clinical laboratory is a very substantial challenge. It is essential to realize that reliability is not inherent to this technology but must be addressed carefully and questioned systematically.

Experimental results and method validation data from two analytical case studies of complex small?molecule pharmaceuticals illustrates the utility and advantages of UHPLC in high-resolution separations.

Experimental results and method validation data from two case studies of complex small-molecule pharmaceuticals illustrate the utility and advantages of UHPLC for quality control.

This instalment describes recent advances and best practices in HPLC analysis of intact monoclonal antibodies (mAbs) and their variants and fragments.

The latest approaches to antibody characterization go beyond ion-exchange, size-exclusion, and reversed-phase modes to make use of affinity, hydrophobic interaction, mixed-mode, and HILIC techniques.

Laboratories all around the world stand or fall by their reputation for accuracy and quality control.

Using narrow-bore column fast GC combined with rapid scanning qMS to analyse flavours and fragrances is described.

This quality control of bioethanol verifies maximum concentrations of methanol, higher alcohols and other impurities in bioethanol.

The evaluation of the state of a biological sample before starting the complex analyses is a crucial step in proteomics studies. This paper compares planar polyacrylamide gel electrophoresis (SDS-PAGE) and capillary on-the-chip SDS GE (CGE-on-the-chip) in terms of the speed of analysis, sensitivity and flexibility. Snake venoms, which are heterogeneous with high bioactivity and consist mainly of proteins with a molecular weight mass range below 100 kDa, were investigated. CGE-on-the-chip was found to be a faster and more stable technique, providing more information than classical SDS-PAGE. CGE-on-the-chip was also capable of detecting many compounds over a broad molecular weight mass range whereas the SDS-PAGE is more time-consuming and provides acceptable resolution either in the very low (below 17 kDa) or in the mid- to high-molecular mass region (16–200 kDa) depending on the gel/buffer-system selected.

Because GPC is a reliable, simple and fast characterization method it can be readily adopted to investigate the separation behaviour of membranes.