SAFC takes on transgenics and India
recent CPhI in Paris with announcements regarding its expansion
activities in transgenic manufacturing and India.
First of all, the company said its Pharma business segment is expanding its cGMP protein purification capacity "to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials."
"Our new facility will be one of the only cGMP transgenic manufacturing facilities in the world and also one of the largest," SAFC spokesperson Amanda Halford told a press conference.
"The market is moving away from purely animal-based products and we want to make sure we are well positioned to move with the market," she said.
The new operations will be added to the firm's St. Louis, Missouri manufacturing campus and will feature completely separate plant and animal protein processing facilities to eliminate potential cross-contamination.
The natural and recombinant (transgenic) plant proteins facility will occupy 22,000 sq. ft. for its upstream and downstream processing operations.
"This is a huge capacity which is important when you consider how much plant matter you need to use in production," said Halford.
The animal-sourced proteins facility will encompass over 20,000 sq. ft. for upstream processing and be supported by an area that contains over 300,000 sq. ft. of total capacity.
SAFC said it is working closely with numerous transgenic plant platform companies to develop commercial-scale processes for proteins previously available only from animal-sourced materials and for therapeutic proteins and monoclonal antibodies.
The company said it is also experiencing strong demand for cGMP proteins from animal-sourced materials for use in medical device applications and active pharmaceutical ingredients (APIs).
"Recent successes in the transgenic plant market combined with advancements of several of our natural APIs derived from plants have provided impetus to expand our capacity," said SAFC President, Frank Wicks.
"We have several projects moving into late-stage clinical trials and commercial manufacturing and are expanding to meet growing customer demand."
Meanwhile, SAFC also chose the CPhI to announce that its Pharma business segment's 139,000 sq. ft. medicinal chemistry facility located in Bangalore, India, is now ready for operation.
The facility features over 60,000 sq. ft. of production and R&D laboratory space, including manufacturing suites for chemical development and production to 50L scale and an on-site warehouse, said the firm.
"The operation offers a complete range of pre-clinical, process development and scale-up services combined with access to the favourable economics of India."
SAFC said the $12m (€9.6m) facility is part of its "build or acquire" strategy, put in place to meet the increased demands for its medicinal chemistry and cGMP manufacturing services.
Other recent SAFC capacity and technology expansions include the purchase of the SAFC Arklow, Ireland facility - a large-scale API manufacturing site with 90,000L of cGMP capacity; the acquisition of SAFC Pharmorphix, a Cambridge, UK based solid-state research studies company; and an $18m expansion of the SAFC Madison high-potency chemistry facility.
"We are particulary trying to build up or acquire new capacity and capabilities in low-cost areas such as India," said Halford.
"All our staff at the new Indian plant have been fully trained at our existing facilities in Manchester and Swizerland," she told In-PharmaTechnologist.com.
In addition, Halford said that 24 hour workshift extensions are being introduced at the company's Gillingham API manufacturing and Manchester medicinal chemistry and development facilities in the UK in order to further cope with demand.
In other developments, SAFC said it has just been chosen by medical innovations company BTG to provide chemical development services relating to BGC20-1259, a potential treatment for Alzheimer's disease.
Under the terms of the deal, SAFC will conduct process research and development studies on the synthesis of BGC20-1259 at its Manchester facility in order to determine a suitable process for the manufacture of sufficient clinical trial quantities of the compound.
SAFC is hoping it will then be given the honour of manufacturing of the drug during its journey through clinical trials and into commercialisation.
