The new SAFC biopharma manufacturing facility in St. Louis enables the production of plant- and animal-based proteins for drug development. The $18 million facility was created by retrofitting an existing building and contains some of the largest extraction and purification suites. It addresses customer concerns about cross-contamination by having completely separate operations for plant and animal production. The flexible facility can support multiple custom projects simultaneously while meeting strict quality standards on time and under budget.

1. Science and Technology
Highlights
McCarthy Builds World-Class Biopharma Manufacturing Center
Summer 2008
®
The new facility enables SAFC to ensure protein purity for the Biopharma industry
“
Proteins derived from natural tion, completely eliminating the
plant- and animal-based sources are potential for cross-contamination. The $18-million facility,
becoming increasingly important obtained by retrofitting and
components in the manufacture A platform for growth
of key biologic drugs. However, expanding a unit built in
The $18-million facility, obtained
there are often concerns about the by retrofitting and expanding a unit the early 1990s, contains
potential for cross-contamination. built in the early 1990s, contains
SAFC, the custom development
some of the largest
some of the largest extraction and
and manufacturing services unit of purification suites of their kind, extraction and purification
”
Sigma-Aldrich, recently started up capable of supporting products suites of their kind…
a facility at its St. Louis site that is from pre-clinical development to
among the first commercial-scale full commercialization.
unit of its kind to have completely Kunkel, director of production
segregated operations for plant- “A new, larger-capacity facility was for Sigma-Aldrich Manufacturing.
and animal-based protein produc- just a logical extension of what we “One of the company’s goals is
were already doing,” said Lance to grow its contract manufactur-
ing business in this area,” said
Kunkel. “To do so, it needed a
world-class facility that met the
industry’s strict Current Good
Manufacturing Practices (cGMP)
to showcase the company’s unique
expertise and capabilities in biolog-
ics manufacturing.”
That meant SAFC also needed to
address the concerns that prospec-
tive customers might bring to the
table, such as:
Customer Issue #1: Fears of
cross-contamination
“One of the first things potential
Buffer Prep Area customers look for in such a facility
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2. is the potential for cross contamina-
tion between the animal and plant
sides of the operation,” said Dick
Kalin, Sigma-Aldrich’s project
manager for design and construc-
tion. With these products, there
is potential for animal protein
virus to migrate to another source.
“Customers don’t want to see
workers—or anything else—moving
from one area to another,” explained
Kalin. “That’s why one doesn’t
typically find adjoining facilities for
both plant and animal sources.”
SAFC’s facility has been designed
“ Potential customers
appreciate hearing about
a contract manufacturing
”
facility’s flexibility.
and constructed to segregate the
two sides into two totally indepen-
dent operations. As a result, the
Clarification Area
animal and plant protein opera-
tions share electrical power, drain-
age systems, fire systems and an contamination in the exhaust and “We have done everything we can
external façade—but not much else. intake systems, strobic fans have to eliminate possible causes for
Each maintains its own separate been installed on exhaust systems, concern,” Kalin said.
entrances, exits, locker rooms and preventing exhaust air from re-
HVAC systems. entering the building. Customer Issue #2: Can you
Once inside, efforts to eliminate meet MY needs?
Workday duties are also restricted
the potential of cross-contam- by facility. Employees of the plant- Potential customers appreciate
ination are visible everywhere. source facility wear green uni- hearing about a contract manufac-
Equipment and raw materials forms when involved in the initial turing facility’s flexibility. But, what
enter and leave through separate plant protein extraction process, they really want to know is: can it
entrances and exits on each side of and blue uniforms when working handle their product? Given the
the facility. The USP water dis- in the plant protein purification sheer variety of products poten-
tribution systems are segregated suites. Employees who work in tially processed there, the project
by facility as well, as is the storage animal protein processing areas team went to great pains to ensure
space for equipment, tools, raw wear maroon. that the answer to that question
materials and consumable supplies. will almost always be, “Yes.”
To reduce the impact of cross-

3. ent products from many different tems as practical,” said Rich Corey,
sources, and they’ll constantly be McCarthy project manager on the
changing. So, they needed a facil- Sigma project.
ity that would be flexible enough to
“SAFC had identified a market need
accommodate custom projects of
and a set amount of funds to invest
almost any scale, and also possess
in serving it,” said Corey. “The
the ability to change over to new
project team’s job was to find a way
products quickly.”
to enable them to achieve their
Such criteria were central to goals,” he said.
the facility’s design. As a result,
“McCarthy drove much of the
processing equipment in the facil-
reuse activities,” said Unrau. “They
ity, which includes Class 100,000
found ways to re-use everything
(ISO 8) and Class 10,000 (ISO 7)
from the electrical and air handling
cleanrooms and a Class 10,000
systems, to HEPA filters and light
(ISO 7) lyophilization suite, can
fixtures and wiring,” he said.
be set up in multiple configura-
tions and arranged to minimize However, not all items that could
flow as well as ease operations be reused were reused, due to
between the extraction, separation concerns about cross contamina-
and purification processes. tion. “In some cases,” said Corey,
“we were required to eliminate
Equipment selection also takes into
account the numerous potential
product sources. The plant-source
facility, for example, is equipped to
process a variety of plant materials,
ranging from milled grains, such
as flour, to chopped leaves, such as
tobacco. Isolated manufacturing
suites make it possible for the com-
“
pany to process up to four different
McCarthy found ways products at once.
to re-use everything
from the electrical and Customer Issue #3: Can you
meet my budget?
air handling systems, to
The stringent requirements for
HEPA filters and light operational flexibility and cross-
”
fixtures and wiring. contamination control could have
wreaked havoc with the project’s
budget—and made it cost-pro-
hibitive both for SAFC and its
“Typically, you design a process and
potential customers. “Capital costs
then build the facility around it,”
were kept in check by renovating
explained Eric Unrau, project man-
and repurposing an existing, aging
ager for CRB Consulting Engineers,
Brownfield site and making judi-
who served as engineer for the
cious reuse of as much of the facil-
project. “But, in this case, SAFC
ity’s existing equipment and sys- CIP Room
will be working with many differ-

4. Extraction Area
“
some otherwise good systems and budget targets, but also supported
put in new ones.” This was accom- the company’s desire to minimize It took a world-class team
plished while working around unnecessary waste and support to produce a world-class
existing operations and, one by one, sustainability efforts.
addressing the myriad challenges project. We’ve received
By the time the 16-month project
associated with upgrading a cen- nothing but compliments
”
was complete, SAFC had 2,500 m2
tury-old building to meet the FDA
of world-class biopharma manu- from our customers…
and EU standards needed for 21st
facturing space, capable of produc-
century biopharma manufacturing.
ing up to 1,000 kg of product per “It took a world-class team to
Ultimately, the recycling, reuse year for a total finished cost of $18 produce a world-class project,” said
and value engineering efforts not million—significantly more cost- Kunkel. “We’ve received nothing
only enabled SAFC to meet its effective per kg of output than but compliments from customers,
more traditional therapeutic pro- which include both large and small
tein facilities, according to Unrau. pharma companies. The commit-
Today, SAFC has achieved what ment to quality, as well as the equip-
it set out to do: demonstrate to ment, support systems and fabrica-
its customers that it can handle tion techniques, are all consistent
multiple types of custom processes with the highest level of protein
and support a full-range of cGMP extraction and purification facilities.”
biologics manufacturing for both
plant and animal sources. And, it
did it on a tight schedule with an
Plant 100K Clean Room
even tighter budget.
For more information contact: Jim Contratto
jcontratto@mccarthy.com
1341 North Rock Hill Road
St. Louis, MO 63124
(314) 919-2343
Science and Technology Highlights is a publication of McCarthy Building Companies, Inc. www.mccarthy.com