Novasign at a Glance

 

We love to model processes!

Accelerating the development of bioprocesses ensures both, earlier and more affordable treatments.

 

Problem statement

​New drugs can take 10-14 years and cost on average $1.8 bn to develop before it enters the market. Consecutively, the net effect is that the price per dose easily exceeds $10,000.

The pressure downstream on the patients, the healthcare systems and insurance is intense with an aging and growing population.

This is why we need novel biopharmaceuticals earlier, and therefore cheaper, on the market!

 

Drug life cycle

We believe that every day & dollar saved, and every data insight gained, benefits the society and business.

We achieve a reduced time to market by an accelerated bioprocess development.

The gap

 

In this three-stage model of discovery, process development and commercialization we illustrate the under-investment in process development and the poor knowledge and generated understanding of bioprocesses.

Almost all resources are invested in drug discovery and commercialization. We believe that this resource 'gap' at the process side has to be tackled, to enable early and affordable bioprocess improvements that yield disproportionate rewards.

Advantages of increased process understanding

 
  • An earlier market entry

  • A higher return of investment

  • Fewer required experiments, i.e., saving on experimental time, energy and materials

  • Deeper process understanding of how critical process parameters impact the products' critical quality attributes in a time-resolved manner

  • Higher transparency for regulatory bodies

  • Straightforward process know-how transfer between different products

We are meeting your needs if you

 
  • are under pressure to reduce development timelines for new drugs, biosimilars and other biologically derived molecules (in red and white biotech)

  • have growing needs for tools to better understand processes with the goal of achieving higher yields or a more stable process

  • are seeking to fulfill the FDA’s QbD and PAT guidelines in a timely and cost-effective manner

Solutions

Developing advanced bioprocess models to accelerate process development

Tackling QbD & PAT, enabling a better design space description and real-time monitoring

 

Building long-lasting knowledge within your company

Advanced modeling toolboxes to support your staff

 
  • Time-resolved hybrid models of your processes

  • Simple export of the developed model as .dll to implement the model for soft-sensor applications and process control

  • Monitor your own progress anytime and anywhere by using the Novasign Portal

About us

linkedin.png
mail.png