Honkanen says, “This room has fire protection system that’s quite
THE FUTURE OF HIGH POTENCY COMPOUNDS
advanced and robust, there are fire protective pipes throughout the
racking systems. If an event should occur, the area can be easily
isolated. We also just implemented electronic inventory controls,
giving us the ability to track inventory down to the exact location.”
SAFC personnel are also kept safe by foot-thick, damage-limiting
concrete walls, specially designed for the high hazard risk environ-
ment that comes with producing active pharmaceuticals with highly
The highly complex side of pharma is only becoming more and
more tailored with more and more growth potential. “In the highly
active/highly complex sector, anti-body drug conjugates are probably the most exciting in the industry right now, and is a growth sector where we have a substantial piece,” says Hanson.
Antibody-drug conjugation technology uses monoclonal antibodies or other biologics to deliver conjugated Highly-Active
Pharmaceutical Ingredients (HAPIs) to targeted cells. In conjugated
form, the HAPI exhibits more selective cytotoxicity, thereby sparing non-target cells from many of the toxic effects. Customers are
quickly adapting these complex technologies and employing them
to develop new oncology products that are more targeted and exponentially more powerful.
“We’re a part of commercial supply chains for the linker payload
portion, and having SAFC St. Louis available to do the commercial
part of the conjugation is a great step in our supply chain,” Klipstine
“SAFC Madison has been in that game on the synthetic side for
a long time, and now, coupled with the growing conjugation capabilities in St. Louis, it’s a great place to be because that business is
growing everywhere,” says Hanson.
ON THE HORIZON FOR SAFC MADISON/VERONA
SAFC has invested a substantial amount into the Madison business with the last two expansions and they will provide quite a
bit of capacity for the time being. The excitement of the Verona
expansion is now finished; the facility is open and the remaining
validation will happen later this year. The company will continue to
evolve in the original facility as well – the Madison site will continue
to be the R&D core.
As we look out onto yet untouched prairie land, Hanson says, “On
the site here in Verona, we’ve only built on about half the acreage,
so there are eight acres left to grow on to. From a strategy stand-
point we are continuing to define what that might look like. The
business has been robust and we consider ourselves a leader in
the area. I think there are a lot of opportunities, but it’s hard to say
what they will look like.”
“There are a lot of factors that will determine the direction of our
growth in the future. And a lot of that depends on our collaboration
with our customers and the success of how they move through pre-
clinical to commercial,” says Klipstine.
“Ten years ago I couldn’t have imagined this, it’s amazing how it
has changed,” says Hanson. ■
Honkanen explains, “The first control is containment, and then
the reach back system, local ventilation, and then PPE. Even though
the systems are enclosed, we do surrogate testing to ensure that
when we’re manipulating materials that our equipment is contained/
sealed. We actually have our operators in secondary PPE – more
than is necessary – to ensure safety.”
The Safebridge methodology allows SAFC to perform highly complex chemistry in any one of the eight kilo labs on the Madison site,
by simply using the appropriate portable equipment and very precise labeling procedures. Process safety is also ensured by the efforts of the process development chemists, who not only find proof
of efficacy, but also confirm the procedures necessary to accommodate the thermodynamics as a process is scaled up.
The core of the Verona expansion includes a vast storage area
protected by a whole host of explosion protection measures.