Page 43 - Imprint-magazine june-Issue

Qualification support

The XDR bioreactor systems are designed
for use in environments that require 21
CFR Part 11 and GAMP™ 5. The systems are
delivered with an operating manual, system
specification, drawings to support qualifica-
tion, and major component documentation.
Industry standard installation and operation DELIVER MORE, FASTER
qualification (IQ/OQ) packages are available
as an option. Increase throughput:
Applications more programs, more molecules

XDR cell culture bioreactor systems have Increase productivity:
successfully been used to cultivate a wide
range of cell types and organisms including
CHO cells, Vero cells, HEK293, and MDCK more product per batch
cells. In addition, a fermentor system is
available for microbial applications includ- Increase capacity:
ing E. coli, Pseudomonas spp., and yeast.
XDR bioreactor systems can be operated in more batches per facility
batch, fed batch, and perfusion (or chemo-
stat) modes. Bioreactor bag design can be EXECUTE HIGH ROI BUSINESS
process dependent, requiring customization DECISIONS
for proper use and performance.

Repligen Reduce bioreactor size up to 10
fold
Introduces from 10,000 L to 1,000 L

XCell ATF®

Technology Accelerate your program

with smaller, flexible intensified processes

Pilot and process scale systems Re-think facility expansion
support robust, linear scale-up lower cost, lower risk, faster results

studies.

Intensification delivers more cells,
more product, faster.

XCell ATF® technology helps develop fast and simple
intensified upstream processes that deliver more
product, faster. Intensified processes achieve higher
cell densities, require smaller bioreactors and con-
sume less suite time. Increase throughput, produc-
tivity, and capacity in both clinical and commercial
manufacturing towards maximizing your facility
utilization, accelerating program advancement and
transforming your business decisions.

High impact upstream applications include N-1
perfusion, high productivity harvest, long-term
perfusion and seed train intensification.

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