A smart and agile development strategy

Step by step solution: from proof of concept to clinical scale

Our development approach 

Exothera’s multidisciplinary structure merges upstream and downstream viral vectors expertise with a Quality by Design (QbD) approach to meet your needs. 

From small scale to clinical trials we provide comprehensive quick and cost-effective development solutions, supported by the latest analytical methods

viral vectors development process exothera development approach

Development process flow

viral vectors development process flow

Technologies and expertise 

Our team of experts counts more than 20 years of upstream and downstream development experience. Exothera can work with you to develop the best process for your product, with several solutions for adherent and suspension processes and with the best-in-class purification techniques and systems.  

Upstream Development

Through affordable and rapid proof of concepts, we can perform feasibility studies in shake flasks (suspension) or cell factories (adherent) of your latest discovery.

We perform suspension screening studies with DASGIP® Parallel Bioreactor Systems by Eppendorf, and to optimize the number of experiments and boost the statistical value of the data. 

We can adapt your existing process and design cost-effective scale-up thanks to our experience with scale-X™ platform by Univercells Technologies.

viral vectors development process usp
viral vectors development process hydro device
scale-X™ solution

From 2.4 m² to 30 m²  
viral vectors development process dasgip device
DASGIP® Systems Screening  
Up to 16 conditions  
viral vectors development process RM device
Biostat® RM Development    
From 10 L  

Downstream Development

Our team can meet your requests for an efficient development of a purification strategy, thanks to a deep experience with clarification, concentration, chromatography and formulation. We provide best-in-class systems to perform feasibility studies and screening. 

We can perform filtration screening with PendoTECH Filter Screening System™ by PendoTECH  and chromatography screening with ÄKTA avant by Cytiva to optimize your purification process. We can adapt your traditional chromatography steps to continous chromatography thanks to our experience with Contichrom CUBE by ChromaCon. Our deep knowledge of the market and the latest technologies allows us to select the best devices and consumables for the success of your process development.
viral vectors development process dsp laboratory
viral vectors development process viral pendotech DSP device

PendoTECH Filter Screening System™

Filtration Screening
viral vectors development process Kros flo DSP device
Repligen KrosFlo
Concentration & Formulation
viral vectors development process akta DSP device

ÄKTA avant

Chromatography screening
viral vectors development process contichrom DSP device

Contichrom CUBE 100

Continuous Chromatography 

The Quality by Design Methodology

Exothera follows Quality by Design approach, where process development is strictly associated with a predefined clinical performance and product quality. 

Through the definition of Design Space and the help of statistical methodologies, we can provide a development plan optimized to obtain the best solutions in terms of time and costs, within the quality level our client required.  

viral vectors development process Quality by Design (QbD)

Design of Experiment

At Exothera, we use Design of Experiment (DoE) to manipulate multiple factors and parameters at the same and identify possible interaction between them, otherwise undetectable with a traditional approach, with an impact on the number of experiments to perform. Our data scientists will support development team to define a set of experiment that can provide all the information for a successful characterization and optimization of the final process.


Define the DoE objectives and select the parameters of the study, which lead to select the DoE methodology

viral vectors development process DoE parameters definition


Perform the experiment and collect the factor response

viral vectors development process DoE step 2 experiments


Build the predictive model within the design space

viral vectors development process DoE Step 3 data evaluation