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Vernon, NY 13476
877.229.5248
It’s all about building a
company with one
mission, to fight for
what is essential:
YOUR HEALTH!
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Recombinant Generations
The term generation is a descriptor
used to describe recombinant clotting factor products and the technology
used to create them.
The qualifications to be labeled as
one of the various generations vary with the factor type (VII, VIII
or IX).
Over time new procedures were developed
for the manufacturing of recombinant factors and as the newer processes
became used, the term generation was born. Factor VIII products can
be broken down into three generations. To simplify the manufacturing
process; recombinant factors are no longer extracted factor proteins
from human blood (which is how monoclonal and earlier factor products
were made). Recombinant factor proteins are produced by cloned cells
that were genetically engineered specifically for that purpose. These
cells are grown in large vats where they release the factor protein
as a byproduct. From here the protein is separated off, filtered and
cleaned in its purification steps before moving on to being stabilized
during the formulation process. After being stabilized the factor is
ready to be shipped to people with bleeding disorders.
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First Generation |
Second Generation |
Third Generation |
Culture Process |
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Purification Process |
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Stabilization Process |
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Denotes no blood product is used during
this step:
Denotes blood product usage during process: |
- First Generation Recombinant Factors - are manufactured
using a cloned cell bank to actually create the factor protein rather
than simply extracting it from human plasma. While this generation
no longer derives the factor from plasma ), it does use human blood
products as food for cells during the culture process, as well as
the purification and stabilization processes.
- Second Generation Recombinant Factors - While similar
in production to the first generation recombinant product, second
generation recombinants, stopped using human blood products to stabilize
the final molecule but still use them during the culture process or
both the culture and purification processes.
- Third Generation Recombinant Factors - have removed
human blood from the production process all together.
There are only 1st Generation factor
VII and IX recombinant products available, however the technology used
in their production is equivalent to 3rd generation factor VIII products.
They are termed 1st generation only because the process involved in
their production has not been changed since they first became available
and in no way implies the technology used in the factor VII and IX recombinants
is older or less advanced than that used in 3rd generation recombinant
factor VIII.
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