Optimized Process Development for Viral-Based Therapies
Accelerate your viral vector therapy with our proven process development expertise.
Smart & Agile Process Development Strategy
Exothera’s multidisciplinary team merges upstream and downstream viral vector expertise with a Quality by Design (QbD) approach to create cost-effective, high-performance manufacturing processes tailored to your therapy’s specific needs.
With more than 20 years of experience within the team, we optimize every step of development—from small-scale proof of concept to full clinical trials—using the latest analytical methods and bioproduction technologies.
Our Services Include:
Plasmid Design & Production (via preferred 3rd partner)
Upstream (USP) & Downstream (DSP) Process Optimization & Development
Analytical Transfer, Bridging & Development
Cell Line & Media Optimization / Re-selection
Manufacturing of Non-GMP & Toxicology Materials
Process Scale-up & Optimization
Formulation Development & Feasibility Studies
Dispensing into Vials, Storage & Product Delivery
Viral Vector Process Development Workflow
Upstream Process (USP) Development
We develop and optimize both adherent and suspension cell culture processes, ensuring high-yield and scalable viral vector production.
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, to optimize the number of experiments and boost the statistical value of the data.
We can adapt your existing process and design a cost-effective scale-up thanks to our experience with scale-X™ platform by Univercells Technologies.
Scale-X™ Platform
(Univercells Technologies)
(for seamless scale-up from 2.4m² to 30m²)
DASGIP® Parallel
Bioreactor Systems
(for suspension screening & optimization)
Biostat® RM
(Wave Bioreactor)
(for early-stage development from 10L)
Downstream Process (DSP) Development
We provide advanced purification strategies tailored to your therapy, leveraging best-in-class clarification, filtration, chromatography, and formulation technologies.
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.
PendoTECH Filter Screening System™
(for filtration optimization)
(for concentration & formulation development)
ÄKTA avant (Cytiva)
(for chromatography screening & process refinement)
Contichrom CUBE 100 (ChromaCon)
(for continuous chromatography & process intensification)
Quality by Design (QbD) & Design of Experiment (DoE)
We implement a Quality by Design (QbD) approach, ensuring that process development aligns with predefined clinical performance and product quality standards.
Our Design of Experiment (DoE) Methodology
We provide advanced purification strategies tailored to your therapy, leveraging best-in-class clarification, filtration, chromatography, and formulation technologies.
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.
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
By applying statistical methodologies, we reduce the number of experiments needed while maximizing data insights—delivering a robust and efficient development pathway for your viral vector therapy.
Why Partner with Exothera for Viral Vector Process Development?
- Viral Vector Expertise: Backed by team members with 20+ years of hands-on expertise in AAV, adenovirus, lentivirus, and other viral vectors
- End-to-End Support: From early-stage feasibility studies to full-scale clinical manufacturing.
- Innovative Technologies: Access to industry-leading USP & DSP platforms.
- Regulatory-Ready: Development strategies aligned with global GMP & regulatory standards.
- Cost-Effective Solutions: Optimized scale-up strategies to reduce costs & accelerate timelines.
- Award-Winning Recognition: Winner of the ViE Award for “Best Production/Process Development” at the World Vaccine Congress 2025. Industry-validated excellence you can trust.
Looking for more information?
Let’s discuss how Exothera’s viral vector process development capabilities can drive your therapy’s success.