Paras Bio­phar­ma Sets New Bench­mark with PCZ-505

Paras Bio­phar­ma­ceu­ti­cals Fin­land Oy, based in Oulu, has announced the devel­op­ment of a new biosim­i­lar can­di­date, PCZ-505, a tech­no­log­i­cal­ly advanced alter­na­tive to Cer­tolizum­ab pegol (Cimzia®). This marks a major mile­stone in biosim­i­lar pro­duc­tion, com­bin­ing sci­en­tif­ic inno­va­tion with scal­able, cost-effi­cient man­u­fac­tur­ing.

Built on Paras Biopharma’s pro­pri­etary E. coli expres­sion sys­tem, PCZ-505 deliv­ers high yields and low pro­duc­tion costs, paving the way for broad­er access to biosim­i­lar ther­a­pies. The process has been test­ed with five suc­cess­ful batch­es at 15L scale, con­firm­ing robust­ness and repro­ducibil­i­ty.

Key tech­no­log­i­cal high­lights of PCZ-505 include:

• Inde­pen­dent expres­sion opti­miza­tion using cus­tomized E. coli strains
• Effi­cient scale-up from lab to pro­duc­tion (15L to 750L) with in-house stain­less-steel biore­ac­tors
• Inte­gra­tion of Paras’ Dia­brid™ and Noble­Cleav™ tech­nolo­gies for high struc­tur­al fideli­ty
• Stream­lined three-step purifi­ca­tion process to ensure prod­uct puri­ty and con­sis­ten­cy
• Low cost of goods with high-through­put man­u­fac­tur­ing

Advanced ana­lyt­i­cal tools such as HPLC and LCMS QTOF are used to ensure that PCZ-505 meets strict biosim­i­lar stan­dards.

Paras Bio­phar­ma is cur­rent­ly invit­ing co-devel­op­ment and com­mer­cial­iza­tion dis­cus­sions for PCZ-505 with inter­est­ed part­ners.

About Paras Bio­phar­ma­ceu­ti­cals

Paras Bio­phar­ma­ceu­ti­cals Fin­land Oy spe­cial­izes in biosim­i­lars and micro­bial bio­log­ics man­u­fac­tur­ing. The com­pa­ny com­bines pro­pri­etary expres­sion tech­nolo­gies with proven scal­a­bil­i­ty to sup­port part­ners in glob­al bio­phar­ma mar­kets.

Con­tact per­son:
Mark Jack­son, Admin­is­tra­tion Lead
mark.jackson@parasbiopharma.com

Source: Paras Bio­phar­ma­ceu­ti­cals