Process Development

With Polpharma Biologics, you have found your biopharmaceutical one-stop-shop providing all elements required to advance your biopharmaceutical program.

Our cell lines, processes and analytical platforms are fully aligned with cGMP manufacturing capabilities to secure seamless process transfer and scale-up.

We understand that titer matters – let us drive the productivity of your biological process.

 

01

CELL LINE DEVELOPMENT

Our clients benefit from more than 25 years of success in generating high-yield production cell lines for both biosimilars and innovative proteins. Specifically, our competence lies in tailor-made modulation to match the given quality target product profile.

Our proprietary CHOBC® expression platform allows rapid generation of high-quality cell lines with a completely animal component-free (ACF) process. High-throughput technologies are deployed to increase productivity and achieve the highest titers possible, while minimizing undesired species and achieving fingerprint-like biosimilarity, if required.

CHOBC® cells are grown in chemically defined media, and resulting research cell banks are rigorously tested for the absence of viral elements in accordance with ICH guidelines. CHOBC® cell lines have already been successfully scaled-up to 1,000 L and used to produce drug substance for clinical trial supply.

02

Upstream and Downstream Process Development

At Polpharma Biologics, we utilize a number of advanced techniques to quickly establish processes that will yield the optimal outcome at the highest level of efficiency. We apply quality-by-design (QbD) principles to guarantee the quality, safety and efficacy of your products.

Upstream Process Development – Mammalian Systems

We run multiparametric experiments in parallel using ambr® high-throughput systems to optimize media and culture conditions for scalability. Required USP process characterization is performed based on qualified scale-down models and is supported by high-throughput analytical instrumentation.

Our upstream process development capabilities for mammalian cell culture include:

  • Two ambr systems with 48 and 24 parallel 15 ml microbioreactors, respectively
  • 9×1 L Biostat Q mini bioreactors coupled with Novaflex bioanalyzer
  • 10×10 L Biostat bioreactors for process transfer and characterization
  • 1×50 L single-use bioreactor for process transfer and toxicity testing

Upstream Process Development – Microbial Systems

For microbial processes, we have established separate laboratories with dedicated staff to match our capabilities in mammalian development.


Downstream Process Development – Mammalian & Microbial Systems

We leverage a panel of state-of-the-art separation technologies and follow DoE principles to achieve maximum recovery and purity of target proteins. Required DSP process characterization is performed based on qualified scale-down models and is supported by high-throughput analytical instrumentation.

Our downstream process development capabilities for mammalian cell culture include:

  • Allegro™ Single-Use Tangential Flow Filtration
  • ÄKTA™ chromatography systems
  • Automated systems for filtration optimization
03

Analytical Method Development

All required physico-chemical and bioanalytical methods are established and qualified in-house to fully characterize relevant target protein quality attributes, including in-depth analysis of post-translational modifications.

Platform Methods for Physical-Chemical Properties

  • UPLC methods (LC-UV, LC-SEC, LC-IEX)
  • Mass spectrometry (LC-ESI-MS)
  • UV / VIS methods
  • Chip electrophoresis
  • IEF / 2D EF
  • Capillary Gel EF

Platform Methods for Biological Properties

  • Cell-based methods
  • ELISA
  • Radionuclide-based assays
  • Luminescence-based assays
  • FACS
  • PCR

CDMO | DS

Drug Substance Manufacturing

Once process development is complete, we can conduct a smooth and efficient tech transfer to continue on your journey to market.