ISAR Bioscience expands its man­u­fac­tur­ing license and GMP certificate

Planegg, Decem­ber 7, 2025 – ISAR Bioscience has expan­ded its man­u­fac­tur­ing license for its premises in Planegg near Munich fol­low­ing another detailed inspec­tion. This license applies to bio­lo­gical drugs (e.g., anti­bod­ies), and has now been exten­ded to thera­peutic cells (“Advanced Medi­cinal Ther­apy Products,” ATMP) and mRNA lipid nan­o­particles (LNPs, cur­rently part of the approval for gene ther­apies). To this end, the facil­it­ies were again suc­cess­fully inspected.

The man­u­fac­tur­ing author­iz­a­tion under the Ger­man Medi­cines Act (§13 AMG) includes cer­ti­fic­a­tion to work in accord­ance with Good Man­u­fac­tur­ing Prac­tice (GMP), which ensures the high qual­ity of invest­ig­a­tional medi­cinal products through­out the entire man­u­fac­tur­ing pro­cess in accord­ance with European Clin­ical Tri­als Reg­u­la­tion No. 536/2014, European GMP guidelines (espe­cially for novel ther­apy forms, part IV), and those of the Inter­na­tional Coun­cil for Har­mon­isa­tion of Tech­nical Require­ments for Phar­ma­ceut­ic­als for Human Use (ICH – in par­tic­u­lar Q9 and Q10).

As a res­ult, ISAR Bioscience is registered as a fully-fledged drug man­u­fac­turer for these dif­fer­ent products. Rel­ev­ant steps in drug pro­duc­tion can be covered intern­ally by the Qual­ity Assur­ance (QA)/GMP team. Qual­ity-con­trolled pro­duc­tion cell lines have already been estab­lished, which are used to gen­er­ate mas­ter cell banks (MCB) for fur­ther GMP pro­duc­tion of bio­lo­gical drugs. In addi­tion, GMP-com­pli­ant immune cells are pro­duced from human indu­cible pluri­po­tent stem cells (hiPSC). Moreover, vari­ous mRNA-LNPs are syn­thes­ized and for­mu­lated in-house (batch sizes of sev­eral hun­dred mil­li­grams), ini­tially for use in pre­clin­ical studies.

This addi­tional cer­ti­ficata­tion is another mile­stone for ISAR Bioscience. The new man­u­fac­tur­ing author­iz­a­tion and GMP cer­ti­fic­a­tion enable the Qual­i­fied Per­son Suz­ana Levacic-Schulz to per­form GMP-com­pli­ant qual­ity con­trol and batch release for cell thera­peut­ics, such as vari­ous immune cells express­ing chi­meric (auto-)antigen recept­ors (C(A)AR), as well as for mRNA-LNP products.