CSL Behring Monograph Berinert - page 10

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CSL Behring is a global organization that unites its
experience and knowledge of research, development and
production in Australia, Germany, Switzerland, and the
United States (Figure 1). With its full vertical integration,
fromplasma collection to product distribution, the company
sets and meets the highest quality and safety standards.
CSL Behring has been fractionating human plasma for more
than 60 years since 1946 and has developed a highly controlled
system of plasma collection, manufacturing, and distribution
of plasma concentrates to ensure that these products meet
the highest standards of quality from donor to patient.
CSL Behring operates CSL Plasma, one of the world’s
largest plasma collection organizations. Headquartered in
Boca Raton, Florida, USA, CSL Plasma operates more than
70 collection centers in Germany and the United States. Its
quality assurance systems and controls are among the most
rigorous and powerful in the industry.
CSL Behring employs a highly qualified expert team
of virologists to ensure that the most advanced and
appropriate processes are used to help ensure the safety
of CSL Behring products.
CSL Behring is also certified through the QSEAL (Quality
Standards of Excellence, Assurance Leadership) program, a
plasma therapeutics industry (PPTA) certification program.
CSL Behring was one of the first companies to meet QSEAL
certification requirements, which include regular audits
by an independent inspector to assess the company’s
adherence to global industry standards. CSL Plasma is
recognized by the International Quality Plasma Program
for its plasma collection safety and quality standards. This
program established plasma collection standards that meet
and exceed regulations around the world, and each plasma
collection center must meet these standards individually to
become certified.
1.2 A Proven Record of Quality for Clinical Use
Figure 1 – CSL Behring’s Production Facility in Marburg, Germany
CSL Behring
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