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Home Focus Pharmaceuticals

Laboratory competence in R&D

26. September 2018
in Pharmaceuticals
With the Xelum R&D, Bosch allows pharmaceutical manufacturers an ideal start to continuous manufacturing. Picture: Bosch

With the Xelum R&D, Bosch allows pharmaceutical manufacturers an ideal start to continuous manufacturing. (Picture: Bosch)

At the lead­ing phar­ma­ceu­ti­cal trade show CPhI world­wide in Madrid, Bosch Pack­ag­ing Tech­nol­o­gy, sup­pli­er of process and pack­ag­ing tech­nol­o­gy, show­cas­es its lab­o­ra­to­ry exper­tise for oral sol­id dosage (OSD) forms. The new lab­o­ra­to­ry device Xelum R&D for con­tin­u­ous man­u­fac­tur­ing is on open dis­play for the first time. More­over, vis­i­tors can see how the Bosch Phar­ma Ser­vice and Indus­try 4.0 solu­tions sup­port phar­ma­ceu­ti­cal man­u­fac­tur­ers in increas­ing trans­paren­cy and effi­cien­cy of their lab­o­ra­to­ry process­es. “With our wide range of lab­o­ra­to­ry solu­tions, we offer our cus­tomers an ide­al start­ing posi­tion for a fast time-to-mar­ket of their phar­ma­ceu­ti­cals,“ says Fritz-Mar­tin Scholz, prod­uct man­ag­er at the Bosch sub­sidiary Hüttlin.

Reduced development time

The Xelum R&D offers phar­ma­ceu­ti­cal man­u­fac­tur­ers an ide­al start to con­tin­u­ous OSD pro­duc­tion. “The Xelum R&D is the first R&D machine to com­bine charg­ing, dos­ing of sev­er­al ingre­di­ents and blend­ing with gran­u­la­tion, dry­ing and dis­charg­ing in one unit,” Fritz-Mar­tin Scholz explains. In con­trast to con­tin­u­al mass flow, the Xelum R&D dos­es excip­i­ents and active ingre­di­ents as a dis­crete mass. This way, cus­tomers can dose even small­est amounts of APIs of less than one per­cent. Indi­vid­ual pack­ages, so-called X‑keys, con­tin­u­ous­ly run through the process chain and are removed suc­ces­sive­ly from the machine as pack­ages into bins.

Customer support starts with the formulation

Bosch’s lab­o­ra­to­ry port­fo­lio sup­ports cus­tomers in all devel­op­ment and pro­duc­tion phas­es of OSD forms. Every year, rough­ly 1,000 exper­i­ments with sub­stances for var­i­ous indi­ca­tions are con­duct­ed at the company’s com­pe­tence cen­ter in Schopfheim, Ger­many. “The key to achiev­ing a fast time-to-mar­ket while meet­ing the high­est qual­i­ty stan­dards is exten­sive expe­ri­ence and know-how,” says Dr Mar­cus Knoell, Head of Phar­ma Ser­vice Sol­id at Hüt­tlin. “We offer cus­tomers every­thing from a sin­gle source: from for­mu­la­tion and ana­lyt­i­cal devel­op­ment, to sta­bil­i­ty tests and bioe­quiv­a­lence stud­ies and dossier prepa­ra­tion.” A spe­cif­ic focus is on scale-up and tech­nol­o­gy trans­fer: every prod­uct that is devel­oped at the Bosch lab­o­ra­to­ry is tai­lored to the customer’s machines, so that they can lat­er man­u­fac­ture the prod­uct in-house.

Seizing the data treasure

At CPhI world­wide, Bosch also show­cas­es its new data min­ing ser­vice which eval­u­ates exist­ing machine data more effec­tive­ly to iden­ti­fy and elim­i­nate root caus­es. “Machine devi­a­tions are often clas­si­fied as ‘human error’ due to mis­in­ter­pre­ta­tions or miss­ing infor­ma­tion,” Dr Marc Michaelis, expert for con­tin­u­ous pro­duc­tion and process ver­i­fi­ca­tion at Hüt­tlin, explains. “Yet we assume that this is true for no more than ten per­cent.” Bosch’s new data min­ing tool makes it pos­si­ble to exam­ine large amounts of data for the small­est effects using sta­tis­ti­cal meth­ods. “This way we can rec­og­nize hid­den con­nec­tions and elim­i­nate fail­ure caus­es. Large invest­ments are not required. What it takes is tech­ni­cal exper­tise and exten­sive process know-how,” Dr Michaelis says. “Our experts can sup­port phar­ma­ceu­ti­cal man­u­fac­tur­ers all over the world to make the most of their exist­ing data.”

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