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A
wide cross-section of leading companies have already
scaled up their operations with Cellmate.
Instead of increasing labour or redeveloping the
process technology they have chosen automation. |
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| |
Cellmates
are the industry standard. They supply cells and
proteins to screening and other drug discovery research
activities in the majority of the world’s
top 20 pharmaceutical companies.
For
example: |
| |
High
throughput screening
Pfizer chose Cellmate to prepare large, uniform
batches of many recombinant cell lines to help increase
the speed and scale of their drug discovery efforts. |
 |
| |
Around 50
Cellmates have been installed in GMP.
Applications include: |
| |
Human
vaccines
Merck
chose Cellmate for production of their FDA approved
varicella vaccine, Varivax™. |
| |
Gene
therapy
Avigen
chose Cellmate to help manufacture an adeno-associated
viral vectored gene therapy product to be used in
clinical trials. |
| |
Biotherapeutics
Serono chose Cellmate
to automate production of their recombinant human
growth hormone, Saizen™. |
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Veterinary
vaccines
Novartis
Animal Health chose Cellmate to automate
the production of a range of animal vaccines. |
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Process
development
Amgen
chose Cellmate for aspects of their cell culture
process development work. |
| |
Tissue
Engineering
Smith
& Nephew chose Cellmate to propagate
cells for their lead product Dermagraft™,
used in the treatment of burns and ulcers. |
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(1)
Cellmate for GMP applications |
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It is a
requirement of GMP that manufacturers of medicinal
products identify what validation work must be performed
to prove control of the critical aspects of their
particular operations. A key element is the requirement
to demonstrate that production equipment is designed
and manufactured to suit its intended purpose, and
to ensure that the equipment will not present a
hazard to the products, for example to confirm that
product contact parts are not reactive, additive
or absorptive. |
| TAP designs
and manufactures Cellmate with GMP requirements
in mind. The TAP Quality System, manages the design,
manufacture and IQ/OQ qualification of Cellmate
and has been subjected to a number of customer audits. |
| TAP recently
underwent a successful audit by a GMP manufacturer
who has chosen to implement Cellmate systems for
part of their viral vaccine production process.
Cellmates are used in a variety of production applications,
as well as for the supply of cells for drug discovery
research. |
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