Avonex Manufacturing Update: New Liquid Fill-Finish Process Validated
This article was originally published in The Pink Sheet Daily
Biogen Idec has completed validation of a new fill-finish process for the liquid formulation of Avonex.
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The company will have almost 200 MS sales reps by the time Antegren is expected to launch in early 2005. Partner Elan also will contribute specialty reps for the hospital outpatient setting. Biogen Idec's pre-launch efforts are focusing on reimbursement and neurologists' capacities for I.V. administration.
An April 29 Dear Health Care Professional letter says Biogen Idec “may experience” a shortage of the liquid formulation of the MS therapy due to manufacturing impurity issues.
Pre-filled syringe process is experiencing a "technical issue" on the fill-finish side. Biogen has the option to ramp up production of Avonex' original lyophilized powder formulation to make up for shortages on the liquid side.