Contract Manufacturing for Microbial Biologics

Paras Biopharmaceuticals has acquired and fully own a microbial production facility in Finland which was constructed in 2003 as a contract manufacturing site for microbial production of recombinant products in microbial strains. With a total floor area of 25,000 ft2 and a classified cleanroom of 4,300 ft2, other features include media and buffer preparation, live area (fermentation and harvest & extraction), purification suite (three separate rooms, incl. +4°C cold room), final filtration and freeze-drying. Production area in A/B, C and D classes including Operators’ rooms in key areas. Our team has strong experience in carrying out microbial biologics production.

Timelines

GMP manufacturing site established: 2001 to 2003

Contract manufacturing: 2003 to 2009

Internal R&D: 2009 - 2012

Paras Biopharmaceuticals’ Technology development: 2012 onwards

Contact manufacturing: Open

Upstream Development

Paras Biopharmaceuticals’ process development capabilities stem from solid scientific knowledge and an excellent infrastructure. We offer a microbial platform at our production facility in Oulu, Finland where the laboratory is fully configurable to specific client needs.

Process Development:

Our expertise in the development of robust bioprocesses allows the client’s project to be efficiently and effectively integrated into a commercially viable manufacturing process.

Our scales of operation are:

Fermenters: 10L, 150L and 750L (Sartorius) stainless steel bioreactors

Disposable, scalable bioreactor technologies

Process Optimization:

Fermentation processes are optimized to maximize expression and enhance process reproducibility.



Downstream Development

Paras Biopharmceuticals’ core expertise covers all aspect of downstream development. This includes the purification team who are able to automate most of the purification process, whilst our scientists have extensive experience in process optimization to provide the highest product recovery at a small scale. We also provide a full understanding of the scale up parameters to reach a robust production scale process to meet our clients’ needs and high standards.

Process Development:

Paras Biopharmaceuticals provides a complete purification solution including:

Primary separation

Centrifugation / cell disruption

Ultra- and diafiltration using hallow fibre and cassette filters

Liquid chromatography-based purification utilizing leading chromatography systems:

ÄKTA Pilot (GE Healthcare), ÄKTA Process, ÄKTA Explorer 100

AxiChrom 300, AxiChrom 200, AxiChrom 150, AxiChrom 100, AxiChrom 70, AxiChrom 50. (15 columns in total)

Our competence include chromatographic techniques such as ion exchange, hydrophobic interaction, expanded bed, affinity and gel filtration.

Process optimization:

Besides our focus on developing robust bioprocesses with high yield and purity, we employ extensive in-process analytical testing to identify and control process-related impurities. This also includes the monitoring of post-translational modifications of our products such as glycosylation. We deliver a full bio-comparability testing profile for your product.



Technical Features

FACILITY

MEDIA & BUFFER PREPARATION

Constructed in 2003 as a contract manufacturing site for microbial production of recombinant products in microbial strains.

Facility designed by Kvaerner UK (now Aker Solutions) and Elomatic Finland.

 


FREEZE DRYING / LYOPHILISATION STUDIES

  • Total floor area of 25,000 ft2.
  • Classified cleanroom of 4,300 ft2.
  • Media and buffer preparation.
  • Live area (fermentation and harvest & extraction).
  • Purification suite (3 separate rooms, incl. +4°C cold room).

HIGH-PRESSURE LIQUID CHROMATOGRAPHY HPLC-BASED PURIFICATION AT LARGE SCALE

AXICHROM COLUMNS

  • ÄKTA Pilot (GE Healthcare), ÄKTA Avant, ÄKTA Process, ÄKTA Explorer 100.
  • AxiChrom 300, AxiChrom 200, AxiChrom 150, AxiChrom 100, AxiChrom 70, AxiChrom 50. (15 columns in total).

 

Our competence include chromatographic techniques such as ion exchange, hydrophobic interaction, expanded bed, affinity and gel filtration.

High-pressure Liquid chromatography
HPLC-based purification



Microbial Biologics Production

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