Michael E. Swartz

 Volume 33 Number 4Pages 234-247This is our annual review of new liquid chromatography (LC) columns and accessories introduced at Pittcon and throughout the previous year. This year, Michael Swartz, former author of our "Innovations in HPLC" and "Validation Viewpoint" columns, steps in as a guest columnist to write the review.

Our annual review of new liquid chromatography columns and accessories, introduced at Pittcon and throughout the previous year. This year, Michael Swartz, former author of our “Innovations in HPLC” and “Validation Viewpoint” columns, steps in as a guest columnist to write the review.

Highlights of some of the new HPLC and related technology showcased both before and at this year's conference

This year, many HPLC systems focused on facilitating process development, method transfer, and biological analysis.

New chromatography technology for the analytical laboratory is being driven by the ever expanding need and challenge to get more and better information faster, all in an economic climate where cost control is a primary concern. At the same time, samples have become more and more complex, detection limits are being driven increasingly lower, and regulatory concerns, particularly for biotherapeutics, are being increasingly scrutinized.

The authors discuss the specifics of analytical method validation.

The principles and attributes of today's HPLC detectors are discussed, and the advantages and disadvantages of the various detectors are compared and contrasted.

The basics of IC are reviewed and recent advances that may extend this technology to new applications are discussed.

Michael Swartz presents his first annual review of HPLC systems and accessories at Pittcon 2010.

This month's installment of "Innovations in HPLC" discusses the use of HPLC for these recent threats to health and safety.

In the inaugural installment of his new column, LCGC veteran Michael Swartz provides an overview of some of the newer LC technology used in contemporary LC laboratories.

The authors present the first installment in their examination of the basics of method validation.

The authors explore how true (complete) method validation of biopharmaceuticals must be forthcoming.

The guest columnists continue their examination of how statistically rigorous QbD principles can be put into practice.

During the last four to five years, chromatographers have witnessed some significant advances in technology, from the instrument perspective, with systems operating up to 15,000 psi using new and significantly improved detectors, sometimes operating in multiple dimensions, and from the column perspective, with smaller particle sizes and new chemistries and configurations.

Over the past several years, charged aerosol detection (CAD) has become a widely used technology in the pharmaceutical laboratory. From formulation to stability and even quality control, many analysts are turning to this technology due to its advantages of sensitivity, ease of use, dynamic range, and applicability to a wide range of analyses in the drug development process. In this article, we will examine the operation and use of CAD in a regulated environment, briefly address method development and validation specifics, and highlight a few examples illustrating some of its advantages when used in the pharmaceutical laboratory.

This second part of the series describes the data loss inherent in most early method development experiments due to coelution, peak exchange, and the general difficulty of accurately identifying peaks across the experiment trial chromatograms.

This installation of "Validation Viewpoint" describes how statistically rigorous quality-by-design (QbD) principles can be put into practice to accelerate each phase of liquid chromatography (LC) instrument method development.

While the "Validation Viewpoint" column has focused on conventional and recombinant pharmaceutical products, and at times, bioanalytical methods, we have just begun to think about method validation as it relates to -omics type studies.

A very useful construct in engineering and analytical chemistry is the concept of a time-invariant linear system. The properties of the system (as for a mathematical function) are defined by a relationship between the response and the excitation, and ...

To obtain a better understanding of the challenges faced during method development and validation, the authors - in cooperation with LCGC - conducted a survey earlier this year. This column summarizes the results.

This month's "Validation Viewpoint" installment highlights some method validation guidelines used in developing and validating dissolution test procedures.

This installment of "Validation Viewpoint" column addresses, in the hopes of clarifying what the biopharmaceutical industry is required to do today to identify and quantify impurities in their biotech, proteinaceous products.

One issue that has become clear to us throughout courses, workshops, seminars, and various talks on the subject of method validation, is that while many people talk the language, sometimes the individual method validation terms mean different things to different people. While the actual protocols, or experimental details used to measure or evaluate method validation can vary, it's a good idea to have a common understanding of the underlying terms. In this month's installment of "Validation Viewpoint," we have compiled glossary of method validation terms as they pertain to chromatography.

I was first acquainted with LCGC in the mid 1980s. Known then as just LC Magazine, it appealed to any graduate student working in the field of chromatography because it was delivered each month free of charge.

Peptide mapping is one of the preferred techniques for the comprehensive characterization of biopharmaceutical products and is often the analytical method of choice for studying a protein's primary structure.

November 2006. The objective of a formal method transfer is to ensure that the receiving laboratory is well trained, qualified to run the method in question, and gets the same results - within experimental error - as the initiating laboratory. The development and validation of robust methods and strict adherence to well documented standard operating procedures is the best way to ensure the ultimate success of the method. This installment of "Validation Viewpoint" examines the analytical method transfer process, including protocol, documentation, and some possible chromatographic pitfalls to avoid.

After having collected some industry accepted practices for implementing new LC technology, the duo discuss FDA guidance available on the subject with respect to LC, and using some recently introduced LC technology.

The authors define robustness, instroduce a few approaches to designing a robustness study, and discuss data analysis necessary to help ensure successful method implementation and transfer as a part of method validation protocol.

The authors take a look at three recently published documents in the validation literature from groups working to (hopefully!) clear up some of the potential for confusion.