Hic­cup in man­u­fac­tur­ing will cause Gen­Sight to re­peat the process for reti­nal gene ther­a­py; Den­dreon an­nounces col­lab­o­ra­tion with Shore­line Bio­sciences

Four months af­ter a gene ther­a­py Phase III tri­al for reti­nal neu­rode­gen­er­a­tive dis­eases from French biotech Gen­Sight failed de­spite im­prove­ment in vi­sion in pa­tients, the com­pa­ny has an­nounced that it has com­plet­ed three val­i­da­tion batch­es need­ed to gain a mar­ket­ing au­tho­riza­tion ap­pli­ca­tion in Eu­rope for Lumevoq, with a hic­cup that has led to the batch­es to be man­u­fac­tured again.

Man­u­fac­tur­ing large­ly went ac­cord­ing to plan, Gen­Sight said in a press re­lease, as the batch­es were con­sis­tent with­in runs. But a tech­ni­cal is­sue in the fi­nal step of the down­stream process will re­quire the com­pa­ny to do the process all over again, and in­ves­ti­ga­tors have chalked up the er­ror to the op­er­a­tional con­di­tions, not the de­sign of the process.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER