Biomedical Engineering Reference
In-Depth Information
the largest dedicated biopharmaceutical development and manufacturing
investment in the world.
Wyeth invested US$1.8 B in its Grange Castle facility, where site develop-
ment work began in October 2002. The campus comprises three separate
facilities: a drug development unit, a drug substance unit, and a drug pro-
duction facility. These facilities went into production on a phased basis by
2009. Products that are manufactured at the new biotech facility include
Enbrel (etanercept), Prevenar (pneumococcal conjugate vaccine), antihe-
mophilic factor VIII, recombinant human bone morphogenetic protein
(rhBMP-2), Tygacil (tigecycline IV), and Relistor (methylnaltrexone bro-
mide). Construction required more than 15,000 tons of structural steel,
160,000 ft of process piping, 2,400 items of equipment, 7,587 engineering
drawings, and 1,200 specific validation protocols. Zenith Technology was
responsible for the validation of all automated systems. This new facility
is the largest fully integrated facility ever built in a single phase. In March
2007, the Wyeth Corporation announced a further $32 million investment
at the Grange Castle site, which would include the construction of an addi-
tional 6,000 m² of R&D laboratory space. This will then take the total labo-
ratory space available at the site to 8,500 m².
The examples given earlier show the complexity of recombinant manufac-
turing projects. The high cost of these facilities is well reflected in the price
of these drugs in the market and, as long as new molecules keep getting
approved, the trend to construct bigger and bigger facilities would continue.
However, a new phenomenon is happening in the industry with the rise
of biogeneric or biosimilar drugs that would inevitably put pressure on Big
Pharma and, unless they adopt a more cost-effective method of manufactur-
ing, they will be priced out of the markets. Unfortunately, the huge infra-
structure that Big Pharma needs to support would make it difficult to cut
the cost down and, as a result, there is a new type of partnership developing
whereby Big Pharma would outsource the manufacturing of its existing or
even new Active Pharmaceutical Ingredients (APIs) to smaller companies
who are better prepared to adopt the newer technology such as the use of
disposable systems.
One way to look at the value of disposable system is to make compari-
sons of the time it takes to complete a batch. For example, it takes about 50
hours for a batch of a monoclonal antibody to reach from the end of the
upstream stage to purification; using disposable systems, this time can be
reduced by at least 50% by using the GE ReadyToProcess system, an inte-
grated system of disposable components. Similar systems are offered by
Sartorius-Stedim, Pall, and EMD Millipore, the details of which are pro-
vided in Appendix I.
Another advantage of disposable technologies is their portability. The floor
plan of a disposables-based facility can be changed much more easily than
that of a traditional facility. Different process requirements can easily be
addressed by moving equipment into or out of a production suite. Because of
