Biomedical Engineering Reference
In-Depth Information
the approval process quickly and at reduced expense when compared to
building new stainless steel facilities. One trend that is expected to drive
the implementation of single-use technologies is the rise of specific drugs
for smaller patient populations and personalized medicines. Combining
this with the trend for higher upstream yields of an unpurified drug, a
2,000 L bioreactor could easily become the manufacturing tool of choice.
In this way, single-use technologies are closing the gap between develop-
ment, clinical trials, and commercial-scale manufacturing.
The Bio-Process System Alliance (BPSA) is an excellent support portal for
newcomers to disposable systems and also for seasoned practitioners. The
BPSA was formed in 2005 as an industry-led corporate member trade asso-
ciation dedicated to encouraging and accelerating the adoption of single-use
manufacturing technologies in the production of biopharmaceuticals and
vaccines. BPSA facilitates education, sharing of best practices, development
of consensus guides, and business-to-business networking opportunities
among its member companies.
Given in the following is an FAQ derived from BPSA archives:
What makes up a “typical”
Single-Use System (SUS)?
SUSs consist of fluid path components to replace reusable
stainless steel components. The most typical systems are
made up of bag chambers, connectors, tubing, and filter
capsules. For more complex unit operations such as
cross-flow filtration or cell culture, the SUSs will include
other functional components such as agitation systems and
single-use sensors.
What are the primary benefits
of SUSs?
SUSs boast improved productivity, cost structure, and a
reduced environmental footprint compared to traditional
stainless steel facilities. This is driven by the demanding
cleanliness and sanitization standards in the
biopharmaceutical industry. Productivity: Workers spend
much less time changing out disposable systems, then they
do cleaning and sanitizing a traditional stainless steel
system. Cost: Without reusable parts to clean, there are no
chemicals, water, steam, or other utilities used in the
cleaning/sanitizing process. Also, a facility engineered for
disposables is simplified, using less space, so the total
energy consumption is reduced. Environmental footprint:
While the plastics in the SUSs are usually incinerated, the
footprint contributed by this is less than then that
contributed by wastewater, chemicals, and energy used for
cleaning traditional stainless steel systems.
Cost-effectiveness:
Single-use bioprocessing can reduce
capital cost for building and retrofitting biopharmaceutical
manufacturing facilities.
Manufacturing efficiencies:
SUSs
can achieve significant reductions in labor, faster batch
turnaround, and product changeover; SUS modularity
facilitates scale-up, speeds of integration, and accelerates
batch changeovers and retrofits.
