Products
PKII Ultracentrifuge -
Process Development and Small Scale Production
The PKII Ultracentrifuge uses linear scale technology to revolutionize your
downstream process with linear scale-up. Process development begins at a small
scale and rapidly moves to manufacturing scale. To meet your needs for rapid
and efficient scale-up the new series of ‘scale rotors’ can match the volume you need to process.
The PKII fits into
the laboratory environment with its low sample volume; however, the same
centrifuge enables you to do both experimental lots and production
lots. This is made possible by increasing the volume while retaining the
purification profile using the unique linear scale-up core design. Scale-up
is rapid because
the resolution of the product and impurity are identical at all operational
volumes. Allowing for commercial scale production modeled at the laboratory
scale; thereby, enabling rapid bioprocess scale up.
Linear scale experiments
significantly reduce process development time and costs as there is no need
for revalidation of the protocol.
The benefits are:
• Scale-up rotor volume from 0.2 to 1.6 L without protocol modification
• Direct comparison of all results
• No loss of product resolution
• No loss of yield with scale
• Equal process times ensures stability of the product is not lost on scale-up
• Full validation and traceability of data
• Conformity to CSA, CE, 21 CFR Part 11,
GAMP 4 and more
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PKII
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