Injectable Sustained Release Formulations of Therapeutic Proteins

Q Chip Ltd and ARTES Biotech­nol­o­gy GmbH announce that they have signed a Col­lab­o­ra­tive Agree­ment to explore the co-devel­op­ment of a new sus­tained release for­mu­la­tion of inter­fer­on alpha 2a for the treat­ment of chron­ic hepati­tis B and C.

The study is designed to eval­u­ate Q Chip’s Q‑Sphera™ pep­tide and pro­tein deliv­ery plat­form to devel­op a new sus­tained release micros­phere for­mu­la­tion com­posed of bio­com­pat­i­ble poly­mers loaded with inter­fer­on alpha 2a man­u­fac­tured from ARTES´ pro­pri­etary yeast Hansenu­la poly­mor­pha expres­sion system.

Q‑Sphera™ is a high­ly enabling bio-encap­su­la­tion tech­nol­o­gy for the devel­op­ment of poly­mer based sus­tained release sys­tems. No harsh sol­vents or man­u­fac­tur­ing con­di­tions are used in the pro­duc­tion of drug (includ­ing pep­tides and pro­teins) loaded micros­pheres facil­i­tat­ing benign pro­cess­ing of labile molecules.
Hansenu­la based prod­ucts, which are already mar­ket­ed world­wide, are char­ac­ter­ized by safe­ty and cost effi­cien­cy supe­ri­or to oth­er micro­bial tech­nolo­gies. Inter­fer­on alpha 2a man­u­fac­tured from Hansenu­la has proven to be bet­ter tol­er­at­ed than the E. coli reference.

The col­lab­o­ra­tion aims to improve patient com­pli­ance and pro­vide a more con­ve­nient dos­ing sched­ule com­pared with cur­rent mar­ket­ed pegy­lat­ed ther­a­pies through the devel­op­ment of a one month sus­tained release micros­phere for­mu­la­tion. This first phase of the col­lab­o­ra­tion is expect­ed to be com­plet­ed by the end of 2010.