AB BioTechnologies’ new 23,000 square foot state-of-the-art cGMP facility is dedicated to contract development and manufacturing of clinical and small-scale commercial material. Our team brings extensive expertise to assist clients in developing flexible, scalable solutions for liquid or lyophilized products, both large and small molecule. Finished product presentation offerings includes vial, syringe or cartridge.
The facility features the Vanrx Workcell cluster, consisting of the SA25 Aseptic Filling Workcell, Accumulator Workcell, and Lyophilizer Loader Workcell (online in 2019). The SA25 is a completely enclosed gloveless robotic vaporized hydrogen peroxide (VHP) isolator with automated movements to transfer, fill, weigh, and seal units within an ISO 5 environment. This innovative design not only reduces product risk, but also requires fewer resources to operate. In addition, its compact design utilizes a single use sterile product flow path and allows for quick changeovers.
AB will be the first CDMO in the U.S. to marry the Vanrx Workcell cluster with an SP Scientific Hull freeze-dryer. The freeze dryer will be outfitted with SP’s patented, Control-Lyo™ Nucleation on Demand Technology, thus fully leveraging our core competency in lyophilization.
With the addition of our new facilty, expanded laboratories, and growing capabilities, AB has the expertise to take your project from concept to clinic, and beyond.
- GLP Pre-Clinical Manufacturing to Support Tox Studies
- Clinical & Small-Scale Commercial
- Phase I
- Phase II
- Phase III
- Small-Scale Commercial / Orphan Drug
- Vial, Syringe & Cartridge
- Vial Filling (2R-30R)
- Syringe Filling (1-3 ml)
- Cartridge Filling
- Liquid & Lyophilized
- Large & Small Molecule