DEVELOPMENT

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

Development process flow

Technologies and Experties 

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 solution for adherent and suspension processes and with the best-in-class purification techniques and systems.  

Upstream Development

Though 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 experiment and boost the statistical value of the data. 

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

scale-X™ solution

Scale-up

 

From 2.4 m² to 30 m²

 

DASGIP® Systems

Screening

 

Up to 16 conditions

 

Biostat® RM

Development  

 

From 10 L

 

NevoLine™

Large scale

 

Manufacturing Platform

 

Downstream Development

Our team can meet your requests for an efficient development of a purification strategy, thanks 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 our experience with Contichrom CUBE by ChromaCon.

Our depth knowledge of the market and the latest technologies allows us to select the best devices and consumables for the success of your process development.

PendoTECH Filter Screening System™

Filtration Screening

Repligen KrosFlo

Concentration & Formulation

ÄKTA avant

Chromatography screening

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.  

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.

STEP 1

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

STEP 2

Perform the experiment and collect the factor response

STEP 3

Build the predictive model within the design space