Biologics Production / Manufacturing

Paras Biopharmaceuticals Finland Oy (Paras) offers optimized scale-up biologic and manufacturing technologies whilst specialising in microbial fermentation based recombinant productions. Paras’ aim is the commercial production of biologics APIs (Active Pharmaceutical Ingredients) with our core competence geared towards scale-up and GMP manufacturing. In addition, through our partnering network, we offer integrated services for final fill and finish.

Production Facility Technical Features-

Biologics Manufacturing Premises

Total floor area 2300 m2

Classified cleanroom 400 m2

Production area in A/B, C and D classes Operators’ rooms in key areas,

Modern R&D Laboratory Facilities

Paras process development capabilities stem from solid scientific knowledge and an excellent laboratory infrastructure at our facilities in Oulu, Finland. Built in 2001, it includes modern labs which are fully equipped with the most advanced analytical equipment, Bioreactors and protein purification equipment (AKTA Exploter 100, AKTA pilot and Axichrom columns etc).

Analytical Laboratory Facilities

Production facilities in Oulu, Finland are fully equipped with modern analytical equipment:

  • HPLC (Agilent 1100)
  • GC (Agilent 6890)
  • CE (Hewlett Packard 3D CE)
  • Toledotitrators DL53 and DL38 (KF)
  • MettlerToledorefractometer RE40D
  • FT-IR Spectrometer (PerkinElmer Spectrum One)
  • SDS-Polarimeter (Jasco P-1020)
  • UV/ Vis Spectrophotometer (Shimadzu UV-2401 PC)
  • TOC Analyzer (Shimadzu TOC-5000A)

Production Support Systems

Production facilities possess support systems in four key areas: air handling, waste decontamination, alarm management and validation.

Support Systems – Air Handling

  • Live area: two fresh air units, no circulation, exhaust secured with double fans
  • Purification suite, media and buffer preparation area and final filtration / freeze-drying area: three fresh air units with circulation
  • All the units are connected to building’s own standby power system

HVAC and SCADA Control System

Production facilities are fully equipped with modern process utilities, HVAC system and SCADA controls allow flexible production capabilities for biologic-products. Together with state-of-the art clean room technology and production equipment, a range of capacities in fermentation and downstream processes are available.

Support Systems – Waste Decontamination