SAFC adds biologics capabilities at 2 plants

When Roche ($RHHBY) announced this week that it will invest nearly $900 million beefing up its biologics manufacturing, it shined a spotlight on the importance of this category of specialized drugs. Contract manufacturers have seen this trend too, and many are boosting their own capacities in various parts of biologics hoping to ride the growing momentum. St. Louis, MO-based Sigma-Aldrich ($SIAL) is among those.

The company's SAFC custom manufacturing business is making investments that will lead to commercial-scale antibody drug conjugates (ADCs) manufacturing at a facility in St. Louis. It is also expanding its high-potency active pharmaceutical ingredient (HPAPI) manufacturing and storage at its Verona facility near Madison, WI, which it said is complementary to the work in St. Louis. The company did not provide any indication of how much the expansions will cost.

It said the addition in St. Louis would provide segregated areas for high-potency solids handling, manufacturing and aseptic bulk filling and that the ADC expansion should be complete by the middle of 2015. ADCs target specific cells for delivery of drugs, often in cancer treatments. By the middle of next year, Sigma-Aldrich said the Verona facility will have a new warehouse with storage capacity for raw materials and three new cGMP manufacturing areas. Two of those will be for smaller lab-scale manufacturing in the kilo range, while the other will accommodate larger-scale manufacturing up to 800 liters. The facility expansion will also provide space for growth of SAFC's product stability sample storage and testing service, as well as a process scale-up lab to support GMP production.

"Verona's HPAPI handling and containment standards enable the site to manufacture the high-potency toxins and linkers that the St. Louis site uses to conjugate biological molecules and develop ADCs," said Dave Bormett, director of operations for SAFC.

The importance of this area of drug manufacturing was made clear when Roche said this week that it will invest 800 million Swiss francs ($881.8 million) and add about 500 jobs over the next 5 years to deepen and broaden its biologics manufacturing network. It will build a new ADC manufacturing facility in Switzerland and expand its biologics manufacturing operations at two plants in California and one in Penzberg, Germany.  

Roche is the leader in sales of biologics, so its needs are large. But many drugmakers will turn to contractors to help them with new biologic products, and so many of the contractors are investing in biologics capabilities as well. Last week, Sweden-based Recipharm said it will spend €32 million ($43.4 million) to expand its lyophilization capabilities at a plant in Germany. Freeze-drying can be used to stabilize compounds in complex biologic drugs until they are reconstituted for injection. Most biologics are injected drugs, leading some contractors to beef up those capacities as well. Vetter, the Germany-based company that specializes in contract aseptic filling, said last week that it will invest $100 million at sites in Germany and the U.S. that will allow it to build capacity and keep pace with "evolving regulatory requirements."

-  here's the release

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