CONTRACT development and MANUFACTURING ORGANIZATION (CDMO)
Thanks to our state-of-the-art and fully-equipped facilities, we can satisfy even the highest demand regarding the development, manufacture of viral vectors by using bioreactors at the scale of 200L, 1000L. 2000L.
Reliability and competence for your manufacturing needs
GMP Facility
ReiThera team has extensive experience in the development and manufacture of a number of viral vectors starting from wild-type strains and transgene engineering to GMP BDS/DP vaccine production.
ReiThera’s facility consists of 870 m2 cGMP production suites, 170 m2 quality control laboratories, and more than 700 m2 of GMP and research support service space. The facility contains Four independent EC Class B/C cGMP viral manufacturing suites, two non-viral cell culture suites, Class C media prep suite and a Class B aseptic filling suite with the necessary attendant support spaces to meet cGMP operational requirements. A new area of 1.300 sqm dedicated to large scale production including a clean cell room, a media preparation room and a production area with 1000L and a 2000L bioreactors, will be validated in 2021.
The prevention of cross-contamination during concurrent campaigns is based on physical and temporal segregation of GMP activities following defined procedures and signage. All necessary open product operations are conducted in certified Class II-A2 exhausting biosafety cabinets (BSC) to maintain aseptic conditions. ReiThera produces GMP viral cell culture, up to a 3000L scale, and manufactures in four independent HVAC isolated suites with each suite capable of supporting concomitant GMP activities.
Non-viral cell culture maintenance and expansion is supported in two independent dedicated suites. The upstream cell culture and infection steps for BDS manufacturing rely on a WAVE bioreactor (up to 100L volume) and a state-of-the-art suite which includes stirred tank bioreactors at the working volume of 200L, 1000L and 2000L. Downstream processing counts on GE Life Sciences ÄKTA chromatography and TFF systems.
Fill-finish services for drug product manufacture are supported by a dedicated EC Class B filling suite containing an oRABS isolator with a Watson-Marlow Flexicon FCP50W fully automated aseptic filling machine. Filling operations have been validated and up to 2.000 vials can be accommodated.
Committed to quality
Process Development Unit
ReiThera’s PD team has a strong expertise in the development of processes of upstream cell culture and downstream purification for adenovirus, MVA and AAV production using modern tools and technologies.
The upstream process comprises the production of viruses both from adherent or suspension-adapted cells by using fixed bed bioreactor like cell factory or Carbo-X bioreactor or stirred-tank bioreactors up to a scale of 50L. The downstream process is optimized to meet stringent regulatory demands.
In this context, state-of-the-art chromatography technologies are implemented to reduce contaminant levels and improve product quality. Accurate clarification and concentration steps (based on tangential flow filtration) assure high productivity yields.
Our team’s expertise also includes the development of novel analytical methods based on customer needs.
