Process development for Biosimilars

Creating scalable upstream and downstream processes

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.

Creating scalable upstream and downstream processes for biosimilars

Our biosimilar process development focuses on quality and reducing cost. We know that it is critical to reduce overall cost of goods and the way we design our processes increases titer without increasing media and feed requirements. We carefully monitor all our process changes with our enhanced bioanalytical capabilities to ensure we don’t affect biosimilarity.

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 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 downstream process development capabilities for mammalian cell culture include:

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

Working with our process development team

“We are committed to positive outcomes and delivering projects on time to specification”

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.

Contact us

Let’s collaborate and create quality biologics together.

Get in touch for more information.