Capabilities

OVERVIEW

Polpharma Biologics leverages our in-house expertise, technology and capacity to develop high-quality biosimilars for a range of indications. We have fully integrated our biomanufacturing capabilities to facilitate the development of these important therapies,
utilizing our proprietary CHOBC® cell line for optimized output.

  • Cell line development (including proprietary modulation toolbox)
  • Definition and characterization of CQAs for the development of several biosimilars
  • Complete drug substance and drug product process development (phase I, phase III and commercial) for biosimilars
  • State-of-the-art analytical characterization methods available

Our Process

 

Drug Substance

Cell Line Development
  • CHOBC® cell line platform
  • Proprietary modulation toolbox
  • Media optimization
  • High-throughput technologies
Method Development
Physical-Chemical Properties
  • UPLC methods
  • Mass spectrometry
  • UV / VIS methods
  • Chip electrophoresis
  • IEF / 2D EF
  • Capillary Gel EF
Biological Properties
  • Cell-based methods
  • ELISA
  • Radionuclide-based assays
  • Luminescence-based assays
  • FACS
  • PCR
Lab-Scale Process Development
Mammalian
UPSTREAM PROCESSING
  • 2 ambr systems 48 & 24
  • 9×1 L Biostat Q mini bioreactors with Novaflex bioanalyzer
  • 10×10 L Biostat bioreactors
  • 1×50 L single-use bioreactor
DOWNSTREAM PROCESSING
  • GE ÄKTA™ chromatography systems (Äkta Avant 25 and 150, Äkta Purifiers, Äkta Pilot 600 with AxiChrom columns (ordered))
  • Millipore µCogent and Sartorius Sartoflow Smart Tangential Flow Filtration systems.
  • Perkin Elmer JANUS® Automated Workstation for small scale purification, screening and process optimization
  • Sartorius Zero T Automated filterability systems for filtration optimization
Microbial
UPSTREAM PROCESSING
  • 10 L Infors glass bioreactor
  • Panda 2000 Plus homogenizer
  • Akta Flux TFF systemBullet
DOWNSTREAM PROCESSING
  • GE ÄKTA™ chromatography systems (Äkta Avant 25 and 150, Äkta Purifiers, Äkta Pilot 600 with AxiChrom columns (ordered))
  • Millipore µCogent and Sartorius Sartoflow Smart Tangential Flow Filtration systems.
  • Perkin Elmer JANUS® Automated Workstation for small scale purification, screening and process optimization
  • Sartorius Zero T Automated filterability systems for filtration optimization
Pilot Development / Scale-Up
GMP Production
Mammalian
  • Separate production suite operated by dedicated staff
  • cGMP manufacturing 2×1,000 L (nominal volume)
  • Upstream &downstream process in single-use technology
  • Scale up to 50 L, 250 L and 1000 L bioreactor
Microbial
  • Separate production suite operated by dedicated staff
  • cGMP fermentation scale of 500 L / batch (nominal volume)
  • Upstream process including primary recovery in stainless steel technology
  • Downstream process in single-use technology
REGULATORY SUPPORT
  • Regulatory CMC
  • GMP, regulatory & compliance
QUALITY ASSURANCE / QUALITY CONTROL
  • Facilities compliance with EU and US GMP requirements
  • Quality control
    • In-process control testing
    • Product release testing
    • Facility & environment control
    • Stability studies
    • Extractables & leachables

 

Drug Product

Formulation Development
  • High-throughput and automatized equipment for formulation screening and development
  • HIAC and MFI™ equipment for particles counting and characterization
  • Freeslate Junior robotic station
  • Chip electrophoresis
  • IEF / 2D EF
  • Flexicon laboratory-scale filling machine
Method Development
  • Particle detection and morphology
    • DLS
    • SEC-UPLC
    • MFI
    • Light obscuration
    • Visual inspection
  • Conformational change by DSC & FT-IR
  • Chemical stability with an array of UPLC & MS-based methods
Process Development
Aseptic Fill-Finish
  • Liquid fill & finish combi-line for vials, syringes & cartridges
  • Throughput up to 3,000 units per hour
  • Lyophilizer (5 sq m)
  • RABS to secure aseptic filling conditions
REGULATORY SUPPORT
  • Regulatory CMC
  • GMP, regulatory & compliance
QUALITY ASSURANCE / QUALITY CONTROL
  • Facilities compliance with EU and US GMP requirements
  • Quality control
    • In-process control testing
    • Product release testing
    • Facility & environment control
    • Stability studies
    • Extractables & leachables

Biosimilars | CP

Biosimilars Current Programs

We have an expanding portfolio of biosimilars currently in development to treat a wide range of ophthalmologic, autoimmune and oncologic diseases.