Process Development

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 multi-parametric 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
  • 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 BioBLU® c SUBS at either 3, 10 or even 50 L scale ((DoE) process modulation, development and transfer)
  • 10×10 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 utlize our know-how, state-of-the-art equipment and proprietary technologies to deliver a process optimized for your therapeutic.

Biosimilars

Cell Line Development

We take a different approach to other companies when developing biosimilar cell lines, we focus on delivering high titer cell lines and then tailoring modulation to match the given quality target product profile.

Biosimilars

Biosimilar Cell Lines

Ready to go, high expressing manufacturing biosimilar cell lines ready for development. Includes fusion proteins, enzymes and monoclonal antibodies which are available for out-licensing.

Biosimilars

Analytics & Bioassays

We have the most extensive bioanalytical and bioassay toolbox to ensure and test biosimilarity with originator therapeutics.

Biosimilars

Manufacturing

We provide Drug Substance and Drug Product manufacturing for clinical and commercial supply at our cGMP facilities, including fill & finish.