Capabilities
Process Development
Optimizing Bioproduction for Scalable Viral Vector Manufacturing
Our Process Development Unit is focused on designing and optimizing upstream and downstream workflows to ensure scalable, cost-effective, and GMP-ready manufacturing of viral vectors.
Upstream Process Development
ReiThera’s upstream platform supports efficient vector production using both adherent and suspension-adapted cell lines across multiple bioreactor technologies.
Bioreactor Systems
- Fixed-bed bioreactors (Scale X Hydro and Carbo bioreactors; iCellis Nano; Wave bioreactors)
- Stirred-tank bioreactors (2L to 50L)
- Orbital Shaker Systems
This versatile setup enables rapid Proof-of-Concept (PoC) studies and early-stage process development, with a seamless path to clinical-scale manufacturing.
Smart Scalability and Intensification
Our team integrates process intensification strategies—including ATF-based perfusion systems—to boost biomass and viral yield, ensuring scalability without compromising robustness.
We apply advanced cell culture technologies and bioprocess optimization, fine-tuning key parameters such as:
- Cell line selection
- Media formulation
- Bioreactor control (pH, DO, temperature)
This precision approach minimizes timelines and production costs, while maximizing yield and process reproducibility.
Seamless Transition to GMP Manufacturing
Upstream and downstream development activities are closely aligned with GMP manufacturing requirements from early stages to enable an efficient technology transfer.
The platform supports reliable scale-up from small-scale development to large-scale clinical manufacturing, ensuring process consistency and operational robustness.
This approach facilitates a smooth transition from development to GMP manufacturing, supporting accelerated progression from laboratory to clinical production.
Tailored Purification for Every Platform
We design robust, scalable purification processes for each viral vector platform—ensuring process reliability and product consistency across applications.
Technologies & Techniques:
- Ion exchange chromatography
- Affinity chromatography
- Size-exclusion chromatography
Each method is selected and optimized based on the unique biophysical properties of the vector, supporting effective impurity clearance and high recovery yields.
Integrated with GMP Manufacturing
Following process development and optimization, both upstream and downstream processes are transferred to the GMP manufacturing facility at the appropriate scale.
The facility supports this transition through:
- Scalable bioreactor capacity up to 2000 L
- Dedicated, state-of-the-art manufacturing and purification suites
- Full capabilities for clinical and commercial vector production
This integrated approach ensures alignment between development and manufacturing, facilitating a smooth scale-up while reducing technology transfer risk and enabling efficient progression toward clinical and commercial supply.
Downstream Process Development
Purification Strategies for Safe, Effective, and Scalable Viral Vector Products
At ReiThera, downstream process development is central to delivering clinical- and commercial-grade viral vectors with uncompromised quality, purity, and efficacy.
Process Characterization & Regulatory Readiness
To enhance process understanding and support regulatory compliance, our teams conduct:
Identification and control of Critical Process Parameters (CPPs)
Definition and monitoring of Critical Quality Attributes (CQAs)
These activities support the development of robust and reproducible processes, aligned with regulatory expectations and suitable for clinical and commercial manufacturing.
Data-Driven Optimization with DoE
A cornerstone of our approach is the Design of Experiments (DoE) methodology. By applying DoE, we:
- Systematically evaluate key process variables
- Optimize purification conditions with scientific precision
- Define a robust design space for scalable tech transfer
This empowers us to deliver downstream processes that are not only efficient and high-yielding—but also validated, controllable, and GMP-ready.
