CE and HPLC in biotechnology

trendsinanalytical chemisstry, vol. IO, no. 9,199l

Computerized

VII

quality control

Computerized Qrcality Control: Programs for the Analytical Laboratory, 2nd Edition, by T.F. Hartley, Ellis Horwood, 1990, US$ S9.95, ISBN: 0-13151614-O This book contains six chapters dealing with important aspects of quality control. It also lists various programs (in Basic for PC compatible systems) which can be easily applied in the laboratory. The first chapter covers the calibration and the control of calibration Linear calibration is illusgraphs. trated by the LINCALIB program. Some useful considerations on commercially available programs are given, e.g., the care which the analyst should take when using such programs. Data evaluation should not be a result of some witchcraft delivered by mysterious black boxes. The authors similarly discuss and illustrate non-linear calibration (two programs SPLINE and CURVEFIT). The second chapter deals with batch quality control. It illustrates how to evaluate the number of samples to be analysed out of a batch in relation to the precision of the analytical method and “consumer requirements” in order to assess the acceptable proportion of outliers (OCCURVE program). This chapter also deals with the detection and evaluation of bias when comparing methods or results of two laboratories. A geometric mean regression program (CMREG) is given and illustrated with an example. Chapter 3 develops between-batch QC with the Cusum (cumulative sum) chart system. How to apply the Vmask method to detect drifts is illustrated and explained. For a similar purpose the authors have developed the “Trigg tracking signal” and thus compare it to the V-mask system. Chapter 4 deals with data processing from intercomparison studies of methods and laboratory performance. For the evaluation of laboratory performancc the authors suggest the use of non-parametric statistics for which they give an example of a program (CONCORD) and its application.

Chapter 5 is a survey of laboratory standards (laboratory reference materials, calibration standards) to help the analyst detect time dependent effects (instability) and intra-batch variations (homogeneity). Chapter 6 gives practical information on computer handling, interfaces, LIMS etc. This book covers the essential steps in quality control where computers can be successfully applied. It will certainly help those who are starting in the field of QC or PhD students who are faced with the evaluation of their analytical data. Examples are mainly from the field of clinical chemistry and therefore analysts from other areas will have to use their imagination. In the chapters where the performance of programs are compared (e.g. V-MASK and REPORT, SPLINE and CURVEFIT), the reader will perhaps miss

the absence of a common simple application example. It would help the reader to evaluate more rapidly the differences of the output and the respective advantages of the programs. Finally, it would be advisable for a future edition to include an introductory chapter giving general considerations on QC and quality assurance so that the user knows which aspects are covered by the described computer programs. Despite some of the above remarks this book can be recommended to all those who are interested in computerized quality control and in QC and QA in general. All programs described in the book are available on flopy disk (5.25 and 3.5 inch disks) from the publisher. E. A. MAIER Dr. EA. Maier is at tlte Commission of the European Communities, Rue de la Loi 200, B-1049 Brussels, Belgium.

CE and HPLC in biotechnology Analytical Biotechnology: Capillary Electrophoresis and Chromatography (ACS Symposium Series, Vol. 434), edited by Cs. Horv6th and J.G. Nikelly, American Chemical Society Washington, DC, 1990, US$ 49.95, (viii + 214 pages), ISBN: l&8412-1818-6 This volume was developed from a symposium sponsored by the Division of Analytical Chemistry of the American Chemical Society, at its 196th National Meeting in September 1988. Roughly half of the contributions are quite ambitious in their scope, with work presented in a broad context and an extensive referencing to the literature. “Strategies for an Analytical Examination of Biological Pharmaceuticals” by E. Canova-Davis et al. and “Analytical Chemistry of Therapeutic Proteins” by R.M. Riggin and N.A. Farid, when read together, provide an excellent overview of the characterisation of protein products. There are clear explanations for the choice and use of different analytical methods, and practical examples from the authors’ labor-

atories with emphasis on human relaxin, hGH and t-PA, HPLC is the workhorse technique described in these chapters, and it is interesting to make comparisons with the research presented in the chapter by K. Kalghatgi and Cs. Horvath on “Micropellicular Sorbents for Rapid Reversed-Phase Chromatography of Proteins and Peptides”. This describes the great improvement in speed of analysis which can be obtained using non-porous sorbents for protein and peptide separations. Again, examples are plentiful, and referencing is good. To contrast with the results described using HPLC, the chapter by R.G. Nielsen and E.C. Rickard, “Applications of Capillary Zone Electrophoresis to Quality Control”, shows that CE techniques can also be used to analyse intact proteins and protein digests. Characterisation of hGH by CE is discussed, with particular emphasis on the ability of CE to provide good quantitative information. The final chapter, devoted mainly to analysis of recombinant protein products, is that by V. Anicetti on “Improvement and Experimental Validation of Protein Im-

trends in analytical chemistry,

VIII

purity Immunoassays for Recombinant of DNA Products”. The development an antigen-selected immunoassay with selection and enrichment of certain antibodies by affinity chromatography is described, an interesting contrast to the separation techniques in the rest of this volume. The remaining chapters on CE are rather mixed in their subject matter and quality. Chapter 1 is a review article on CE by N.A. Guzman et al. entitled High Resolution Nanotechnique for Separation, Characterisation, and Quantitation of Micro-and Macromolecules: Capillary Electrophoresis”. Unfortunately this overview of CE is rather idiosyncratic, particularly with regard to instrumentation, and the presentation is poor with numerous typographical errors. For example, Fig. 2 is wrongly attributed, and references 86 and 87 appear in the text but not in the reference list. Also on the subject of CE, S.L. Pentoney et al. in Chapter 4 describe at length three different radioisotope detectors, con-

trasting the performance of each design. In Chapter 3, L. Hernandez et al. describe the separation of standard samples of cyclic AMP, GMP, and IMP by CE. One chapter, by R.A. Bradshaw et al., describes the use of mass spectroscopy (MS): “The Amino Acid Sequence-Mass Spectrometric Analyses of Mating Pheromones of the Ciliate Euplotes ruikovi”. A broader review article on MS in analytical biotechnology would also have fitted well into this book. The remaining chapters deal with preparative chromatography, and perhaps rest a little to one side of the main focus of this text. D.D. Frey presents work on “Minimum Variance Purity Control of Preparative Chromatography with Simultaneous Optimization of Yield: Using HPLC as an On-Line Species-Specific Detector”, which adds a touch of chemical engineering to the flavour of the book. The final chapter, by G. Vighet al., provides an enthusiastic account of the utility of cyclodextrin columns used in the dis-

vol. 10, no. 9,1991

placement mode for preparative separations of enantiomers and positional isomers. A pleasing aspect of this volume is the high quality of presentation of most of the camera-ready manuscripts. Publication was commendably fast since the last manuscript was only received at the end of April 1990, and so much of the work reported is quite up to date. The editors do not claim this volume to be a textbook of analytical biotechnology, rather a forum to present recent research which demonstrates the breadth and potential of the field, with emphasis on chromatography and CE. They have succeeded in this aim with the chromatographic sections of this volume, but have not overall been so fortunate with the sections concerning CE. D.K. LLOYD David K. Lloyd is Assistunt Professor at the Department of Oncology, McGill Univers& Montreal, PQ, Cunudu.

A classic on NMR now in paperback Principles of Nuclear Magnetic Resonance in One and Two Dimensions, by R.R. Ernst, G. Bodenhuusen andA. Wokuun, Clurendon Press, Oxford 1990, L20.00, (viii + 6lOpuges), ISBN: 0-19855647-0 All NMR spectroscopists should celebrate the paperback release of this book, which is already a classic. In 1987, I purchased a copy of the hardcover edition the day it arrived at the Today my copy is well bookstore. thumbed; it opens automatically to key pages; it seems to greet me like an old friend. The book is thorough in planning and execution. It is a modern exposition on NMR, ranging from first principles to elements of imaging. There are many useful illustrations, and the typesetting of equations is of the highest quality, as we have come to expect from the Oxford University Press. Although it covers many advanced topics in depth, it has points of easy entry for the neophyte spectroscopist.

The book reads like a rich novel. We follow a cast of characters, while powerful themes recur and interact. The Hamiltonian and the relaxation super-operator repeatedly struggle for control of the nuclear density matrix; the outcomes of these battles are spectroscopic lineshapes. The coherence transfer pathway formalism is a central theme which is introduced early, and which grows in meaning as two-dimensional experiments are brought to the fore. It is hard to read this book and not conclude that the authors have a genuine love for the subject. This book belongs in every chemistry library and on the bookshelf (or desktop!) of every NMR spectroscopist. The release of a paperback edition makes the book more affordable and available, and should be celebrated. JAMES PEKAR Dr. J. Pekur is at the In Mvo NMR Research Center, Building IO,Room BID125, National Institutes of Health, Bethesda, MD 20892, USA.

TrAC Contributions The Editorial Team of TrAC wishes to make it known that articles for this journal are generally commissioned. Prospective authors who have not been asked to write should first approach one of the Contributing Editors, or the Staff Editor in Amsterdam (see below), with a brief outline of the proposed article including a few references. Authors should note that all manuscripts are subject to peer review, and commissioning does not automatically guarantee publication. Short items of news, etc. and letters may be sent without prior arrangement to: Mr. D.C. Coleman, Staff Editor TrAC, P.O. Box 330, 1000AH Amsterdam, The Netherlands.