Facility
A state-of-the-art site
ReiThera’s facility is a state-of-the-art site designed for the development and GMP manufacturing of viral vectors and biologics. Spanning over 3,470 m², it includes 870 m² of cGMP production suites, 400 m² of quality control laboratories, and more than 700 m² dedicated to GMP and research support services. A newly validated 1,500 m² area is fully dedicated to large-scale manufacturing and includes a clean cell room, a media preparation room, and a production area equipped with 1,000L and 2,000L bioreactors.
The facility houses four independent EC Class B/C cGMP viral manufacturing suites, two non-viral cell culture suites, a Class C media preparation suite, and a Class B aseptic filling suite—all designed to meet the highest cGMP standards. The design enables the segregation of operations through physical and temporal separation, following rigorous procedures and dedicated signage to ensure full compliance and contamination control. All open product operations are performed in certified Class II-A2 exhausting biosafety cabinets to maintain aseptic conditions.
ReiThera has extensive experience in the development and manufacturing of a wide range of viral vectors—from wild-type strains and transgene engineering to full GMP production of both Drug Substance (BDS) and Drug Product (DP). Viral production activities are supported in four independently controlled HVAC zones, each allowing parallel GMP manufacturing campaigns up to a 3,000L scale.
3,470 m²
Total Area
870
m²
GMP production suites
400
m²
Quality control (QC) laboratories
700+
m²
GMP and research support services
1,500
m²
Newly validated expansion area
The upstream process for BDS manufacturing utilizes a range of technologies including WAVE bioreactors (up to 100L) and stirred tank bioreactors with working volumes of 200L, 1,000L, and 2,000L. Fixed-bed bioreactors with a cultivation surface area of up to 30 m² are also employed, offering flexibility across different production platforms. Downstream purification relies on industry-leading GE Life Sciences ÄKTA chromatography systems and tangential flow filtration (TFF) units.
Fill-finish operations are carried out in a dedicated EC Class B suite equipped with an oRABS isolator and a Watson-Marlow Flexicon FCP50W fully automated aseptic filling machine. The system is validated for GMP filling of up to 3,500 vials per batch, with manual filling options available for small-volume or small-batch production.
Non-viral cell culture processes are handled in three independent, dedicated suites for maintenance and expansion, supporting research and clinical programs with the same quality standards applied to viral vector manufacturing.
Bioreactor Capacities
Stirred-tank bioreactors:
- 200L, 1,000L, and 2,000L
WAVE bioreactors:
- Up to 100L
Fixed-bed bioreactors:
- Cultivation area up to 30 m²
Downstream Purification Technologies
GE ÄKTA chromatography systems
Tangential Flow Filtration (TFF) platforms
Fill-Finish Capabilities
Automated filling system:
- Watson-Marlow Flexicon FCP50W
- Located in EC Class B suite with oRABS isolator
Maximum filling capacity:
- Up to 3,500 vials per batch
Manual filling:
- Available for small-scale or early-phase production