OUR SERVICES
We support your viral vector vaccine or gene therapy product development
From pre-clinical to cGMP manufacturing
Exoscan
Process Analysis
We carry out an in-depth review of your current process and its clinical and commercial potential within 8 weeks.
The comprehensive development plan identifies areas for optimization that can fast-track the clinical phase, prepare for competitive commercial launch and act as a financial roadmap for fundraising or board endorsement.
- EProcess and data analysis
- ERisk and gap identification
- ETechnology comparison and selection
- ECost modelling
Process Design
& Development
At Exothera, we accelerate the development of new viral vector treatments at every step from process development and optimization to scale-up for manufacturing.
We create custom-made bioproduction programs designed to use the latest technologies for both adherent and suspension cell culture.
Our Design of Experiment (DoE) aims to achieve cost-effectiveness and high performance viral manufacturing that is tailored to the requirements of our customer’s particular therapy.
- EPlasmid design and production*
- EUSP and DSP process optimization and development
- EAnalytical transfer, bridging and development*
- ECell line and media optimization / re-selection*
- EManufacturing of non-GMP and toxicology materials
- EProcess scale-up
- EFormulation development*
- EDispensing into vials
- EStorage and product delivery
GMP Manufacturing
At Exothera, we have extensive GMP, Quality Control (QC) and Quality Assurance (QA) experience. Our 2 GMP commercial-scale factories cover 2,120 m² allowing us to produce tailored and fully supported GMP products.
We partner with you to provide manufacturing capabilities for clinical & commercial needs using a range of scalable platforms to suit your therapeutic.
Get access to bioproduction capacity and expertise to deliver complex projects more quickly and cost-effectively
- EAdherence platform: up to 2 X 600m²
- ESuspension platform: 2 x 2000L
- ECMC support
- EGMP banking: MCB, MVS, WCB and WVS
- EGMP manufacturing, testing and release services
- EFill & finish
- EStorage
- EStability studies on Drug Substance and Drug Product
- EWe take in charge* HQ Grade or GMP Plasmid manufacturing
* supported in whole or in part by partner company
Exoscan
Process Analysis
We carry out an in-depth review of your current process and its clinical and commercial potential within 8 weeks.
The comprehensive development plan identifies areas for optimization that can fast-track the clinical phase, prepare for competitive commercial launch and act as a financial roadmap for fundraising or board endorsement.
- EProcess and data analysis
- ERisk and gap identification
- ETechnology comparison and selection
- ECost modelling
Process Design
& Development
At Exothera, we accelerate the development of new viral vector treatments at every step from process development and optimization to scale-up for manufacturing.
We create custom-made bioproduction programs designed to use the latest technologies for both adherent and suspension cell culture.
Our Design of Experiment (DoE) aims to achieve cost-effectiveness and high performance viral manufacturing that is tailored to the requirements of our customer’s particular therapy.
- EPlasmid design and production*
- EUSP and DSP process optimization and development
- EAnalytical transfer, bridging and development*
- ECell line and media optimization / re-selection*
- EManufacturing of non-GMP and toxicology materials
- EProcess scale-up
- EFormulation development*
- EDispensing into vials
- EStorage and product delivery
GMP Manufacturing
At Exothera, we have extensive GMP, Quality Control (QC) and Quality Assurance (QA) experience. Our 2 GMP commercial-scale factories cover 8,600 m² allowing us to produce tailored and fully supported GMP products.
We partner with you to provide manufacturing capabilities for clinical & commercial needs using a range of scalable platforms to suit your therapeutic.
Get access to bioproduction capacity and expertise to deliver complex projects more quickly and cost-effectively
- EAdherence platform: up to 2 X 600m²
- ESuspension platform: 2 x 2000L
- ECMC support
- EGMP banking: MCB, MVS, WCB and WVS
- EGMP manufacturing, testing and release services
- EFill & finish
- EStorage
- EStability studies on Drug Substance and Drug Product
- EWe take in charge* HQ Grade or GMP Plasmid manufacturing
* supported in whole or in part by partner company