Kiadis Pharma to receive GMP man­u­fac­tur­ing license and GMP cer­tifi­cate

Amsterdam, The Netherlands, July 23, 2013 – Kiadis Pharma B.V., a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing treat­ments for blood can­cers, announced today that its Quality Control (QC) lab­o­ra­to­ry and the asso­ci­at­ed Quality sys­tem has been inspect­ed for good-man­u­fac­tur­ing-prac­tice (GMP) by the Dutch Health Care Inspectorate (IGZ) and has ful­ly met the EU GMP stan­dards. As a result, Kiadis Pharma will receive a GMP man­u­fac­tur­ing license and GMP cer­tifi­cate for its QC lab­o­ra­to­ry from the Dutch Ministry of Health, Welfare and Sport.
GMP licens­ing and cer­ti­fi­ca­tion enables Kiadis Pharma to per­form QC release-assays for the clin­i­cal tri­al man­u­fac­tur­ing of the Company’s lead prod­uct ATIR™, a cel­lu­lar ther­a­peu­tic that will enable par­tial­ly mis­matched donor stem cell trans­plants from fam­i­ly mem­bers in blood can­cer patients.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “This is an impor­tant mile­stone for Kiadis Pharma as we are com­mit­ted to the high­est stan­dards of man­u­fac­tur­ing. We are delight­ed that our QC lab­o­ra­to­ry and the asso­ci­at­ed Quality sys­tem will receive a GMP man­u­fac­tur­ing license and GMP cer­tifi­cate. This not only attests to the qual­i­ty that we have estab­lished at Kiadis Pharma, but secures the path­way to take ATIR™ to the next stage of devel­op­ment. ATIR™ is cur­rent­ly in an ongo­ing Phase II study to con­firm and extend some excit­ing data. We expect the Phase II results in H1 2014.”

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