University Hospitals of Geneva (CH) are using the AT-Closed Vial® and the Crystal® M1 Filling Station for aseptic filling of products for hospital use. This R&D project for cyto products stability testing started in 2014 in collaboration with the University of Lille II (FR). 
Midatech Pharma (ES) is using the AT-Closed Vial® Technology for preclinical studies of a nanomedicine product. This project was kicked-off in 2016, starting with rental of a manual Crystal® M1 Filling Station and has been rapidly scaled-up to automated process with Crystal®L1.
ReNeuron (UK), a clinical-stage biotech company developing allogeneic cell-based therapies, is using the AT-Closed Vial® Technology. The automated solution for aseptic filling Crystal® L1 is selected for scaling-up.
Celgene (US) switched to the AT-Closed Vial® Technology in 2010, after using cryobags for their autologous cell therapy products. Today Celgene is equipped with 3 units of Crystal® M1 and in 2015 they have initiated development of the automated thawing system ThawSTAR® AT6 by Biocision (US).
Secure manual aseptic filling with typical capacity of 180 vials/hour. For installation in common Biosafety Cabinet (BSC). All product path systems are disposable. For R&D or small cGMP batches.
Biologicals
Our solutions have been developed to meet latest challenges of biopharmaceutical manufacturing, optimizing aseptic fill&finish processing and ensuring uncompromised level of sterility.
Our solutions present specific advantages for monoclonal antibodies (mAbs) aseptic filling:
Product loss minimization
During all product path: from liquid transfer and aseptic filling to transportation of filled batches
Increased sterility assurance level
Contamination risks elimination by environment isolation
Easy-to-launch processing
Only 8 weeks between your decision and small scale cGMP aseptic filling start-up
Reduction of validation time
Less steps – less risks: get your ready-to-use devices accompanied with all validation data
Integrated solutions
Small footprint filling equipment, barrier systems, ready-to-use devices and vials for timesaving operations
During all product path: from liquid transfer and aseptic filling to transportation of filled batches
Increased sterility assurance level
Contamination risks elimination by environment isolation
Easy-to-launch processing
Only 8 weeks between your decision and small scale cGMP aseptic filling start-up
Reduction of validation time
Less steps – less risks: get your ready-to-use devices accompanied with all validation data
Integrated solutions
Small footprint filling equipment, barrier systems, ready-to-use devices and vials for timesaving operations
"One out of hundred stories"
UCB Pharma (BE) is using the AT-Closed Vial® Technology since 2015 for several R&D projects focused on mAbs. Stability batches were filled using Crystal® M1 Filling Station installed in biosafety cabinet.
Our solutions present specific advantages for RNA/DNA based products aseptic filling:
RNase-free, DNase-free
Ready-to-use AT-Closed Vial® and devices
Product loss minimization during process
From liquid transfer and aseptic filling to transportation of filled batches
Product loss minimization during administration
More efficient product withdrawal thanks to stopper design
Minimizing risks of contamination
And cross-contamination with single-use devices and isolation of environment
Easy-to-launch processing
Only 8 weeks between your decision and small scale cGMP aseptic filling start-up
Reduction of validation time
Less steps – less risks, get your ready-to-use devices accompanied with all validation data
Ready-to-use AT-Closed Vial® and devices
Product loss minimization during process
From liquid transfer and aseptic filling to transportation of filled batches
Product loss minimization during administration
More efficient product withdrawal thanks to stopper design
Minimizing risks of contamination
And cross-contamination with single-use devices and isolation of environment
Easy-to-launch processing
Only 8 weeks between your decision and small scale cGMP aseptic filling start-up
Reduction of validation time
Less steps – less risks, get your ready-to-use devices accompanied with all validation data
"One out of hundred stories"
eTheRNA Immunotherapies (BE), a VUB university spin-off, is using the AT-Closed Vial® Technology since 2011 for their RNA-based products. Today eTheRNA wishes to capitalize on its mRNA-production experience built over the last years by offering CMO activities.
Our solutions present specific advantages for vaccines aseptic filling:
Product loss minimization
During all product path: from liquid transfer and aseptic filling to transportation of filled batches
No WFI, no wet utilities
Disposable devices for all product path for lean manufacturing
Flexibility
Multicontainer filling equipment, multiple-use disposable aseptic connector for bulk transfer
Seamless scaling-up
Same process from R&D to industrial scale
Reduction of validation time
Less steps – less risks, get your ready-to-use devices accompanied with all validation data
Increased sterility assurance level
Contamination risks elimination by environment isolation
During all product path: from liquid transfer and aseptic filling to transportation of filled batches
No WFI, no wet utilities
Disposable devices for all product path for lean manufacturing
Flexibility
Multicontainer filling equipment, multiple-use disposable aseptic connector for bulk transfer
Seamless scaling-up
Same process from R&D to industrial scale
Reduction of validation time
Less steps – less risks, get your ready-to-use devices accompanied with all validation data
Increased sterility assurance level
Contamination risks elimination by environment isolation
"One out of hundred stories"
Today, 80% of vaccines manufactured by GSK worldwide are passing through our aseptic connection system.
