Thermo Fisher Scientific and Agere Pharmaceuticals Collaborate to Offer GMP Hot Melt Extrusion
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Thermo Fisher Scientific Inc., has announced a cooperation agreement with Agere Pharmaceuticals Inc., which will enable customers to accelerate formulation development of pharmaceutical compounds.
The partnership is intended to reduce time and cost during proof of concept studies by means of hot melt extrusion and granulation. The two companies also possess a deep know-how in solid dispersions of poorly soluble compounds.
Thermo Fisher will install its Thermo Scientific Pharma 16 HME twin-screw extruder at the Agere GMP facility located in Bend, Oregon.
Agere can provide in-depth knowledge of solid dispersions and Thermo Fisher offers outstanding experience in hot melt extrusion, which will provide customers the ability to access process or formulation development, scale-up and GMP manufacturing at just one site.
Customers will also be able to evaluate formulations using novel testing methodologies and rank formulations with respect to anticipated bioavailability.
“To more quickly develop new formulations, our hot melt extruders offer the latest technology to efficiently produce solid solutions or dispersions in pharmaceutical applications,” said Karl Gerhard Hoppmann, vice president and general manager, Thermo Fisher Scientific Material Characterization.
Hoppmann continued, “We are excited to combine our hot melt extrusion portfolio with Agere’s experience in formulation development. This will provide our customers with easy access to our instruments and it also offers them a complete hot melt extrusion solution for individual pharmaceutical applications.”
“Twin-screw melt extrusion is an enabling technology for many critical formulation challenges in the pharmaceutical industry,” said Dan Smithey, Chief Scientific Officer, Agere.
Smithey continued, “We look forward to offering this exciting Thermo Scientific technology to our customers and to demonstrate its utility in our cGMP manufacturing facilities.”
Thermo Fisher Scientific, one of the pioneers in rheology, successfully supports a wide range of industries with its comprehensive Thermo Scientific material characterization solutions.
Material characterization solutions analyze and measure viscosity, elasticity, processability and temperature-related mechanical changes of plastics, food, cosmetics, pharmaceuticals and coatings, chemical or petrochemical products, plus a wide variety of liquids or solids.