Table of Contents: Articles

Increased Process Understanding Through Monitoring and Scale-Down Models: Case Study of a Cell Culture Harvest Fluid Titration and Filtration Process
by Kurt Yanagimachi, Corey Dodge, and Marisa Hewitt
This article presents a case study demonstrating the use of detailed process monitoring and scale-down modeling in determining the root causes of yield losses in the manufacture of a therapeutic enzyme and identifying alternative technologies to improve the manufacturing process.
Case Study: Parenteral Facility Upgrade Project with Fill Line Install
by Keith Weseli and Michael DiGiovanni
This article presents a case study illustrating project management and commissioning and qualification processes that allowed for accelerated completion of a renovation project.
Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer
by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem
This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.
Retrofitting CIP into API Plants
by Nigel A. Fletcher
This article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.
Solving the Terminology Conundrum
by Robert Adamson, Nuala Calnan, Robert E. Chew, and Steven J. Wisniewski
This article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.

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May 2011 Volume 43 Number 5, pp 389 - 499

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Nature Reviews Genetics
Focus on Gene-Based Therapies
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EDITORIAL
----------------------
No second thoughts about data access p389
doi:10.1038/ng.827
More data than we can handle is no excuse to give up our efforts to
promote data access, but it may make us think about new ways to make it sustainable.
http://links.ealert.nature.com/ctt?kn=74&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0

Variants modulating the expression of a chromosome domain encompassing PLAG1
influence bovine stature pp405 - 413
Latifa Karim et al.
doi:10.1038/ng.814
Michel Georges and colleagues report fine mapping and functional characterization
of a quantitative trait locus with a large effect on bovine stature. They show
that the likely causal variants at this locus modulate expression of a
chromosomal domain encompassing PLAG1 and several other genes.
Abstract: http://links.ealert.nature.com/ctt?kn=32&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0
Article: http://links.ealert.nature.com/ctt?kn=91&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0

Variants modulating the expression of a chromosome domain encompassing PLAG1
influence bovine stature pp405 - 413
Latifa Karim et al.
doi:10.1038/ng.814
Michel Georges and colleagues report fine mapping and functional characterization
of a quantitative trait locus with a large effect on bovine stature. They show
that the likely causal variants at this locus modulate expression of a
chromosomal domain encompassing PLAG1 and several other genes.
Abstract: http://links.ealert.nature.com/ctt?kn=32&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0
Article: http://links.ealert.nature.com/ctt?kn=91&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0

Glycerol-3-phosphate is a critical mobile inducer of systemic immunity in plants pp421 - 427
Bidisha Chanda et al.
doi:10.1038/ng.798
Pradeep Kachroo and colleagues show that glycerol-3-phosphate is a critical mobile
inducer of systemic acquired resistance in plants.
Abstract: http://links.ealert.nature.com/ctt?kn=25&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0
Article: http://links.ealert.nature.com/ctt?kn=104&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0


Mutant nucleophosmin and cooperating pathways drive leukemia initiation
and progression in mice pp470 - 475
George S Vassiliou et al.
doi:10.1038/ng.796
George Vassiliou, Allan Bradley and colleagues perform a Sleeping Beauty
transposon mutagenesis screen to identify insertions that cooperate with
mutant Npm1 to produce acute myeloid leukemia (AML) in mice. They observed
mutually exclusive integrations in Csf2, Flt3 or Rasgrp1 in a high percentage
of cases, providing insights into the molecular pathogenesis of this AML subtype.
Abstract: http://links.ealert.nature.com/ctt?kn=124&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0
Article: http://links.ealert.nature.com/ctt?kn=53&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0

A framework for variation discovery and genotyping using next-generation
DNA sequencing data pp491 - 498
Mark A DePristo et al.
doi:10.1038/ng.806
Mark DePristo and colleagues report an analytical framework to discover
and genotype variation using whole exome and genome resequencing data
from next-generation sequencing technologies. They apply these methods
to low-pass population sequencing data from the 1000 Genomes Project.
Abstract: http://links.ealert.nature.com/ctt?kn=127&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0
Article: http://links.ealert.nature.com/ctt?kn=5&m=36557924&r=MzU0NzkwNjQwNAS2&b=2&j=MTAwMTY2NDYzS0&mt=1&rt=0

MCQs in Pharmaceutical Calculations

MCQs in Pharmaceutical Calculations

This is a revision guide in calculations for pharmacy students and registration trainees. This text is part of the RPS "Tomorrow's Pharmacist" series. The