Austar can provide complete bioprocess systems, including process system of cell culture,separation & purification and subpackage of preparations, which are widely used for biopharmaceutical industry, such as recombinant protein,mAb,vaccines and blood products.
Austar can provides integrated solution from drug R&D, pilot to scale-up,in the up stream process system includes:medium preparation system(preparation and store of medium and feeding),fermentation and cell culture system(fermenter and bioreactor),single use system(single use bioreactor);in the downstream process system includes: filtration system(filtration and ultrafiltration),purification system(chromatography),buffer preparation system(stainless steel and single use),virus inactivated system,emulsification system;subpackage of preparations includes: preparation system(stainless steel and single use),freeze-dried system,partial filling system of sterile,and so on.
Austar can provide customized integrated solution for biopharmaceutical industry according to user's requirements.
These process systems include recombinant protein production process solutions,antibody drug production process solutions,blood products production process solutions etc.
Austar not only has professional knowledge in sterile biological applications and industrial biotechnology, but also the ability of mechanical design (tank、 mixer、pipeline), electrical design, automatic control design, especially for the comprehensive capabilities of process、 tanks、 mixer、 auto-control and manufacture.
Our equipment conform to the highest standard of cGMP、ASME BPE, and meet with the requirements of others relative guidelines (CODAP, ASME, AD-MERKBLAT, BRITISH STANDARD),and will be installed and confirmed under the regulations of cGMP、GAMP、FDA21 part11. Moreover,we will provide quality, test procedure, and full documents to support validation.