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The United States Food and Drug Administration (FDA) has issued a new guidance document, Analytical Procedures and Method Validation for Drugs and Biologics. The guidance is quite general in nature. Anyone hoping for specific recommendations on topics such as which methods to use will be disappointed. Industry experts say that i really isn’t feasible for the FDA to provide detailed recommendations about analytical methods for biopharmaceuticals, however.

When was the last time you reported your results with an estimate of the error associated with the data? You don’t need to because your method is performing within the levels defined by various agencies and which were confirmed by your validation and your daily QC checks. The person for whom you are producing the data is aware of these tolerances and therefore inherently appreciates the associated precision of the data and can make judgements based on this. Not in the world I work in!

In this new video from LCGC TV, Christian Wachsmuth from the University of Regensburg in Germany compares the performance of different ionization methods for GC–MS in metabolic fingerprinting. He also goes on to talk about how GC–MS could be applied in a clinical setting and what developments are needed for this to happen.

What’s in a Name?

We recently published a study of water quality from 550 water wells in the Barnett Shale of North Texas. Using a suite of analytical techniques, we were able to find new evidence of the potential impact of unconventional natural gas extraction on environmental quality.

A team of researchers in Spain has examined the use of commercial yeast products in the production of white and rosé sparkling wines.

A team of chemists and microbiologists from the University of Leicester has developed a new method of rapidly diagnosing the infection Clostridium difficile (C. difficile).

Tetrahydrofuran (THF) - a widely used solvent in gel permeation chromatography/size-exclusion chromatography (GPC/SEC) - is set to be classified as carcinogenic as proposed by the Committee for Risk Assessment (RAC). Analytical laboratories therefore need to find ways to reduce THF solvent use and waste, far beyond the demands of green chemistry. This instalment of Tips & Tricks presents different strategies to meet this goal.

An excerpt from LCGC’s e-learning tutorial on high performance liquid chromatography (HPLC) methods for biomolecule analysis at CHROMacademy.com

The 43rd Symposium of HPLC and Related Techniques (HPLC 2015 Beijing Conference) will take place at the Beijing International Conference Centre, Beijing, People’s Republic of China, from 21–25 September 2015.

Click the title above to open The Column August 07, 2015 Europe & Asia issue, Volume 11, Number 14, in an interactive PDF format.

Click the title above to open The Column August 07, 2015 North American issue, Volume 11, Number 14, in an interactive PDF format.

Dr. Graeme McAlister of Thermo Fisher Scientific will discuss the advances in Orbitrap Tribrid Mass Spectrometry technology with the launch of the new Thermo ScientificTM Orbitrap FusionTM LumosTM TribridTM Mass Spectrometer. Graeme will also touch on how these advances have impacted and will continue to impact proteomics with respect to quantitation, accuracy, throughput, etc.

In this webinar, we will discuss the use of new, affordable HRMS instruments in quantitative clinical research analyses, demonstrating the sensitivity and selectivity of these instruments for this work. Examples of clinical research quantification work in HR full scan or MS-MS mode will be presented and compared with results from triple-quadrupole-MS. We will also discuss an example of Qual/Quan analysis in a study of the fate of an anti-cancer agent in humans, where over 40 metabolites were identified and quantified. We will also show metabolomics data underscoring the versatility of HRMS instruments.

Removal of Contaminant Peaks in Reversed-Phase Gradient Liquid Chromatography for Improved Detection of Pharmaceutical Impurities

This is the first of a four part series looking at what functions and features the authors believe should be in a future chromatography data system (CDS) working within a regulated analytical laboratory. The first part of this series is aimed at setting the scene of where and how a CDS fits within the laboratory operation. In using the term CDS, in the future, this can refer to either a traditional CDS that is familiar to readers or the CDS functions could form part of another informatics solution such as Electronic Laboratory Notebook (ELN) or Laboratory information Management System (LIMS). In the next three parts we make 15 recommendations for improvements to the system architecture, the requirements for electronic working and regulatory compliance.

Gain an invaluable insight into the key methods that are used for biomolecule characterization, process control, and release testing

How to distinguish between LC column overload and detector overload.

What exactly is SFC? Although you may have heard and read much about it recently, it is still rather vague to many a chromatographer.

Recently, Nature and Science Citation Index listed the 100 most cited research papers of all time. Two of these are the classic Bligh-Dyer and Folch lipid extraction methods from the late 1950s. This month we will take a look at the lasting impact of these papers and explore the current state of lipid extractions, including lipidomics.

A memoir of Phyllis Brown-a pioneering chromatographer, a devoted mentor, and a champion for women in science

How to distinguish between liquid chromatography (LC) column overload and detector overload.

There has been a revival of supercritical fluid chromatography (SFC) in recent years, especially in the chiral preparative field, but also more recently in the analytical area. However, SFC is considerably more complex than liquid chromatography (LC), mainly because of the compressibility of the mobile phase. One can say that SFC is a “rubber variant” of LC where everything considered constant in LC varies in SFC. In this review, we go through advances in theory, instrumentation, and novel applications.

Recently, Nature and Science Citation Index listed the 100 most cited research papers of all time. Two of these are the classic Bligh-Dyer and Folch lipid extraction methods from the late 1950s. This month we take a look at the lasting impact of these publications and explore the current state of lipid extractions, including lipidomics.

The PEFTEC International Conference and Exhibition for Petroleum, Refining, and Environmental Analysis will be held on 18–19 November 2015 at the Antwerp Exhibition Centre, Antwerp, Belgium

This instalment provides an overview of high-throughput characterization techniques of drug leads to support small-molecule drug discovery programmes in a pharmaceutical company. Myriad analytical chemistry techniques including separation science methodologies are used to confirm the structures and identities, quantitating the concentrations of stock solutions, and measuring key physicochemical properties of the new chemical entities (NCE). A case study is used here to illustrate the details of these applications in high-throughput characterization.

Agilent Technologies Inc. has announced that Dr. Lawrence J. Lesko from the University of Florida’s College of Pharmacy in Orlando, USA, has received an Agilent Thought Leader Award for his research into preclinical toxicological assessments of new medicines.