Supporting your viral vector vaccine or gene therapy development
- Industry leading titers from pre-clinical to commercial GMP manufacturing
- From the inventors of the iCellis and Scale-X, experience our deep expertise in AAV,
Adenovirus, VLP, MVA, Lentivirus, baculovirus and other viral vectors
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 two GMP facilities cover 92,548 square feet (8,600 square meters) allowing us to produce custom GMP products from pre-clinical to commercial.
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: up to 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
- ECan work with HQ Grade or GMP Plasmid
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