Novasign at a Glance

 
Novasign accelerates bioprocess development and optimization by the application of hybrid modeling software solutions to reduce time to market for new drugs and biosimilars

We love to model processes!

value proposition of Novasign GmbH

Accelerating the development of bioprocesses ensures reduced development timelines and a better process understanding

 

Problem statement

Novasign vision is to reduced time to market and increase treatment availability

​New drugs can take 10-14 years and cost on average $1.8 bn to develop before entering 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

 
process development is done with few recourses and process understanding

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

 
novasign combines the advantages of deep process understanding with process data with hybrid models to build digital twins
  • Faster development timelines

  • 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

 
novasign is looking for customers that want to comply to QbD and PAT guideline, increase their yields and speed up process development for new drugs and biosimilars
  • 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

novasign offers bioprocess modeling consulting and contract modeling

Bioprocess development contract research with powerful equipment due to the proximity to BOKU core facilities (cultivations and purification from HT Screening until Pilot Plant). Also full analytical method spectrum (including SPR, MS...). Combining process and modeling expertise.

novasign builds bioprocessing models for process monitoring and advanced process control

We create process models and thereby process understanding based on the data we receive. For best results, preferably starting projects before data creation.

 

Advanced hybrid modeling toolbox for process modeling. Together with model-based and intensified Design of Experiments processes development timelines can be reduced significantly

 

novasign offers training for the hybrid modeling toolbox for companies and academia

We also build the (hybrid) modeling knowledge within your company.

 
  • Time-resolved hybrid models of your processes

  • Including Digital Twin, model-based and intensified DoE functionalities to speed up your bioprocess developemnt

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

About us

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