Process Development

Creating Scalable Upstream and Downstream Processes

We utilize a number of advanced techniques to quickly establish processes that will yield the optimal outcome at the highest level of efficiency for both upstream and downstream processes.

Upstream Process Development

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 x 1 L Biostat Q mini bioreactors coupled with Novaflex bioanalyzer
  • 4 x Labfors 5 systems from Infors HT, that use Mobius® 3L SUBs ((DoE) process modulation and development)
  • 12 x BioFlo® 320 systems from Eppendorf, that use BioBL c SUBS at either 3, 10 or even 50 L scale ((DoE) process modulation, development and transfer)
  • 10 x 10 L Biostat bioreactors for process transfer and characterization
  • Multiple HyPerforma® 50 L SUBs from Thermo Scientific™ with a HyPerforma G3Pro Controller (process development and transfer)

Downstream Process Development

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

We can support any projects process development and utilize our know-how, state-of-the-art equipment and proprietary technologies to deliver a process optimized for your therapeutic.

Solutions

Discovery & Optimization

Our early stage antibody discovery and humanization platforms are designed to get you a high affinity antibody with the desired binding properties that is ready for the next stage of your project.

Solutions

Cell Line Development

Polpharma Biologics have over 25 years of success in generating high-yield production cell lines for innovative proteins.

Solutions

Analytical Development

We can establish and qualify all required physico-chemical and bioanalytical methods in-house to fully characterize relevant target protein quality attributes.

Solutions

Manufacturing

Our drug substance process development and manufacturing services are fully integrated across our site network for seamless process transfer, scale-up and end-to-end supply chain efficiency.