Key Chal­lenges for the Bio­phar­ma­ceu­ti­cal In­dus­try

BioSpectrum (India) - - BIO ANALYSIS -

● Build Man­u­fac­tur­ing fa­cil­i­ties con­form­ing to USFDA & EU reg­u­la­tory re­quire­ments

● Build GLP Cer­ti­fied pro­tein char­ac­ter­i­za­tion fa­cil­i­ties

● Es­tab­lish An­i­mal test­ing and breed­ing fa­cil­i­ties

● Es­tab­lish Ex­ten­sive Vi­ral Test­ing Fa­cil­i­ties

● Con­fi­den­tial­ity and IP pro­tec­tion

● Short­age of Skilled man­power

● Re­im­burse­ment and in­surance poli­cies for bio­pharma drugs

● In­ad­e­quate fa­cil­i­ties

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