SINGLE USE VERSUS TAINLESS TEEL The transition from processing systems mainly constructed from stainless steel materials to ne composed of single-use/ disposable equipment has been a process that has been going on for some time. We asked our equipment vendors to talk about this transition. “I don’ think we will see a complete re- placement,” says Charter’s Clarke, “but more
and more hybrid solutions are giving the
pharmaceutical industry more flexibility.”
“It (replacing stainless steel with dispos-
ables) is taking place now. There are 100
percent single-use facilities on line now,”
As time progresses and materials and equipment become proven and accepted the use
of the product is sure to grow. As far as
what the short term outlook is for these
technologies in the industry our experts offer their opinions.
"I see a continued adoption for small to
medium sized biopharm and CMO manufac-
turing facilities with equipment changeover
costs as well as re-validation costs being
the major limiting factor for the larger man-
ufacturing facilities,” says Cates.
PUSH VERSUS PULL
Developing new technology and tools for
manufacturing biopharmaceuticals can be
tricky. Sometimes the manufacturers are ahead
of the curve and sometimes the vendors are
– and sometimes they even work together.
“This is joint effort,” says Davis.
“Originally it was being pushed just by
the vendors but now end-users are joining
groups like BPSA and BPE support the shift
Cates offers his view on this dynamic, “We
feel that this is being driven from both sides.
Vendors who want to provide novel as well as
increasing sales, of course, and industry who
are looking for improved process efficiency
with greater product efficacy (yield) with
cost/batch savings to justify the new process.”
“Definitely the industry!” says Clarke.
“The vendors have limited resources and
even the large marketing driven companies
are listening to their customer needs to de-
velop new products.”