QIAGEN N.V. Annual Report 2001

QIAGEN — Focusing the Power of Life Sciences
Knowledge about the genetic contribution to
common disorders such as cancer, heart disease,
and inherited diseases is increasing rapidly. Gene
therapy aims to use this knowledge to target certain
genes whose expression can be modified to
treat, cure, or ultimately prevent disease. To interact
with the faulty genes, therapeutic genes are
transferred into the cells of living organisms, usually
using a biological or molecular vector to ensure
efficient delivery.
Plasmid DNA is increasingly being used as the
vector system of choice for gene therapy due to its
increased safety and reduced manufacturing costs
in comparison to viral vectors. The FDA and other
regulatory agencies require that plasmid DNA
intended for use in humans is manufactured to
cGMP-grade (current Good Manufacturing Practice
grade) and is endotoxin-free. pAlliance, a strategic
alliance between QIAGEN, DSM Biologics, a unit
of DSM N.V., and Valentis, provides contract
manufacturing of bulk quantity plasmid DNA under
full cGMP conditions. The service includes contract
manufacturing of products for any scale, from
preclinical toxicology studies to commercial
products. pAlliance is today considered the
world’s leading consortium for contract cGMP
manufacturing services, thanks to the excellent
technology, infrastructure, and marketing strength
of the alliance members.
QIAGEN today serves a number of leading
pharmaceutical companies. The first mover position
and the long-standing expertise of QIAGEN as the
supplier of consumables and pAlliance as the
service provider ensure QIAGEN’s strong position
in the gene therapy market, supplying customers
who test gene therapy drug candidates in clinical
trials. Ultimately, QIAGEN and pAlliance intend to
supply customers who manufacture and sell genetic
vaccination and gene therapy products as validated
and approved products.
QIAGEN products and
services targeting the
gene therapy market
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In 2001, pAlliance announced that it would
manufacture plasmid DNA-based materials for
vaccines, for use in clinical trials run by the
Wyeth-Lederle Vaccines business unit of Wyeth.
This is one of the largest agreements made by
pAlliance since its initiation in early 1999.