April, 3 2020 Molecular medicine in demand worldwide

BianoGMP starts production of active ingredients for molecular medicine in Gera

Just one year ago, Thuringia’s Min­is­ter of Eco­nom­ics and Sci­ence Wolf­gang Tiefensee opened the expanded lab­o­ra­to­ries and the ultra-mod­ern clean room of BianoGMP GmbH in Gera at the Leum­nitz air­field. He thus her­alded the pilot phase of the pro­duc­tion facil­ity for mol­e­c­u­lar bio­log­i­cal active ingre­di­ents, which is now start­ing reg­u­lar pro­duc­tion oper­a­tions. These active sub­stances enable com­pletely new types of drugs, for exam­ple, which mute and repair over­ac­tive genes or acti­vate the immune sys­tem specif­i­cally against viruses or tumours. «Within a short period of time, we suc­ceeded in estab­lish­ing the com­plex infra­struc­ture, estab­lish­ing the processes for the pro­duc­tion of active ingre­di­ents on an indus­trial scale and obtain­ing the impor­tant GMP cer­tifi­cate. This cer­tifi­cate of «Good Man­u­fac­tur­ing Prac­tice» cer­ti­fies that we work in accor­dance with the strict reg­u­la­tory pro­duc­tion require­ments» explains the expe­ri­enced biol­o­gist and Man­ag­ing Direc­tor Dr. Tobias Pöhlmann. Indus­trial scale means just a few 100 grams of highly pure sub­stance, because the oligonu­cleotides used in mol­e­c­u­lar med­i­cine are extremely effec­tive». Orders for the Gera-based biotech­nol­ogy com­pany come from biotech­nol­ogy start-ups and inno­v­a­tive phar­ma­ceu­ti­cal com­pa­nies from Europe and Asia that use the active sub­stances in their clin­i­cal stud­ies. «The fact that we were able to start pro­duc­tion so quickly is mainly due to our employ­ees who have already done an excel­lent job in the pilot phase — but also to the excel­lent coöper­a­tion with the state author­i­ties and sup­port­ing com­pa­nies from the region,» empha­sizes Dr. Rolf Gün­ther, sec­ond man­ag­ing direc­tor of BianoGMP. «We now hope that the new active ingre­di­ents will be used quickly despite the corona cri­sis — by the way, also for viral infec­tions such as COVID-19».