SAFC Commercial, the custom manufacturing services business
), said that it is expanding two U.S. production facilities to
help drug makers in launching new targeted and cytotoxic
therapies in the market.
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SAFC will expand a commercial-scale antibody drug conjugates
(ADC) manufacturing facility in St. Louis, MO, and boost the
high-potency active pharmaceutical ingredient (HPAPI) production
and storage capacity at the Verona facility near Madison, WI.
These initiatives mirror SAFC's commitment to support customers'
continuity in drug development and commercialization programs.
SAFC expects to complete the expansion of the St. Louis plant by
mid-2015. There will be separate areas for high-potent solids
handling, manufacturing and aseptic bulk filling of products at
the renovated facility. The plant will then be capable of
manufacturing batches of up to 600 Liter per 3 kg under ISO 7
classification and will be ideal for HPAPI containment for
SafeBridge Category 4 compounds.
The expanded plant will have an additional commercial-scale
manufacturing capacity. The capacity will facilitate meeting any
increase in demand for ADC production in future. The expansion
will also allow the ADC production to seamlessly transition from
preclinical to clinical phases and into commercial-scale
production. ADC technologies are highly suitable for target
therapies for chronic diseases like cancer.
The renovated Verona facility, which will be specially designed
with HPAPI handling and containment standards (3), will provide
an ideal set-up to produce the high-potency toxins and linkers
that are used by the St. Louis site to conjugate biological
molecules and develop ADCs.
The expanded Verona facility will have three new cGMP production
areas and a new warehouse with raw materials storage capacity by
mid-2014. Two of the three new cGMP manufacturing areas will be
used for smaller lab-scale manufacturing and the remaining one
for larger-scale manufacturing of up to 800 liters. The expansion
of the Verona facility will also create space for expansion of
SAFC's product stability sample storage and testing service, and
for a process scale-up lab for GMP production.
Sigma-Aldrich is among the leading players in the specialty
chemical space along with
American Pacific Corp.
American Vanguard Corp.
). It is a leading life sciences and high technology company. It
develops, manufactures and distributes various biochemicals and
The SAFC Commercial unit is focused on biochemical production and
manufacturing of complex organic compounds. The division
manufactures and distributes bulk quantities of organic chemicals
and biochemicals used by pharmaceutical, biotechnology,
industrial, and diagnostic companies to develop and produce
Sigma-Aldrich carries a Zacks Rank #2 (Buy).
), with a Zacks Rank #1 (Strong Buy), is a good option for
investment in the specialty chemical industry.