Biomedical Engineering Reference
In-Depth Information
subgram yield; today it is hovering around 10 g/L, which reduces the size
required to about 5% of what it was in the past. A 5 g/L monoclonal cell line
would easily produce 100 kg of material (enough for a generic launch of the
product), with 20,000 L per year or ten batches from a 2,000 L bioreactor: a
size that is currently available for disposable systems.
In the future, manufacturers would not insist on larger bioreactors but bet-
ter cell lines and connecting the bioreactors in a daisy chain to produce CFR
21-compliant variable size batches. See www.mayabio.com .
Integrity
The integrity of large-size bags (1 to 3,000 L) is often questioned; these sizes
are needed to hold media, buffer solutions, and other intermediate prod-
ucts. It is true that flexible bags do not have the strength to hold such large
weights, but they can always be supported by a cage around them to distrib-
ute the weight on the seams and body of the bags. In the future, one will see
engineered dimensions of bags that would eliminate any limitation on the
size of fluids that could be held inside a flexible bag.
Flexibility
Future manufacturing will need to be flexible to handle multiple products,
different production volumes for each product, and rapid changes in market
demand at lower costs. However, many of today's facilities are built to supply
blockbuster-like products with high volume and steady demand. The fixed
configuration is usually product specific or process specific. Introducing new
products into such facilities often requires modifications that can be expen-
sive with long lead times. It is especially challenging to scale production up
or down to market demand as both directions incur financial consequences,
either with significant capital investment or facility charges for idle capacity.
Modular disposable systems would solve all of these constraints.
There is somewhere between 1.1 million and 1.2 million liters of excess
capacity in the stainless steel cell culture and fermentation industry; the
majority of which is represented by reactors exceeding 2,000 L. With
increasing yields, smaller budgets for development, and increase in the
diversity of development projects, the future of bioprocessing rests on
the adoption of smaller-size bioreactors that would be scalable but also
flexible in their size, capabilities, and regulatory compliance. The cost of
operating a 10,000 L bioreactor is well established; unfortunately, it is not
 
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