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With the ability of designing and manufacturing both stainless steel and single use systems, we can offer a variety of flexible solutions, with provision of stainless steel, single use or hybrid systems to meet the actual user process and production requirements, which combine the technical and economic benefits of both stainless steel and single use systems, and meet relevant industry standards such as ISO9001, ASME BPE, etc. 

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Cell Culture & Fermentation Process Solutions

AUSTAR provides users with professional services in the aspect of engineering design, manufacturing, project management, validation and after-sales service etc. Meanwhile, the company provides biological pharmaceutical companies in the field of vaccines, mono-antibody drugs and recombinant protein drugs with customized mammalian cell culture bioreactor and innovated integrated engineering solution in full range from lab to pilot and to commercial scale production.

AUSTAR has the technical advantage of in-house process vessel manufacturing. Combining this advantage with the biological pharmaceutical technology and automation technology, AUSTAR is capable of providing biological pharmaceutical users with a full series of microbial culture fermentation tanks from laboratory research and development to pilot scale and to commercial scale production as well as providing the customized engineering solutions.

Ultrafiltration/Depth Filtration/Virus Removal Process Solutions

AUSTAR provides biopharmaceutical users with engineering solutions related to membrane technology. Ultrafiltration /depth filtration/virus removal equipment can be compatible with Pall and Millipore membrane/cassette. The system is designed with good compatibility and its design can be customized according to user requirements. The design follows ASME-BPE specification and minimizes drug solution residue.

In addition to flexible filtration system design and implementation, AUSTAR also integrates buffer preparation and distribution systems to achieve a fully integrated downstream purification system solution.

Medium Preparation & Distribution Solutions

AUSTAR provides biopharmaceutical enterprises with solutions for the preparation and distribution of media solutions that meet various user requirements. These solutions, including dispensing/preparation module, filtration module and distribution & storage module, can provide sterile media for the growth of cells or microorganisms in either seeding or production bioreactors in upstream bioprocessing.

  • The highly integrated modular stainless steel preparation and distribution system includes various tanks, agitators and sterile filtration etc. Operating platform of the system is with stairs and all instruments and pipes required to meet the user requirements. The system can complete CIP and SIP, medium preparation and distribution management.

  • For research & development, pilot and production scale, modular stainless steel medium preparation systems are available and optimized according to user requirements and layout. 

  • In addition to the stainless steel system, AUSTAR can also provide single-use or Hybrid (stainless steel and single-use) solution to increase the flexibility of the production line and reduce the investment according to different process requirements. 


Buffer Preparation & Distribution Solutions

AUSTAR provides biopharmaceutical enterprises with buffer preparation and distribution solutions that meet various user requirements. The solutions, including preparation module, filtration module and allocation & storage module, can provide buffer of corresponding type and volume for each biopharmaceutical downstream purification steps.

  • The highly integrated modular stainless steel preparation and distribution system includes various tanks, agitators and sterile filtration etc. Operating platform of the system is with stairs and all instruments and pipes required to meet the user requirements. The system can complete CIP and SIP, medium preparation and distribution management.

  • In addition to the stainless steel system, AUSTAR can also provide single-use or Hybrid (stainless steel and single-use) solution to increase the flexibility of the production line and reduce the investment according to different process requirements. 

  • By using the advanced PAT based inline dilution/preparation system, AUSTAR can provide users with a continuous buffer preparation solution, which can effectively reduce the footprint and investment of buffer preparation and distribution system.

Formulation Preparation & Filling Solutions

AUSTAR provides GMP-compliant formulation preparation and filling solutions for biopharmaceutical industry.

  • The highly integrated modular stainless steel preparation and distribution system includes various tanks, agitators and sterile filtration etc. Operating platform of the system is with stairs and all instruments and pipes required to meet the user requirements. The system can complete CIP and SIP and realize sterile connection between preparation and filling.

  • In addition to the stainless steel system, AUSTAR can also provide single-use or Hybrid (stainless steel and single-use) solution to increase the flexibility of the production line and reduce the investment according to different process requirements.

  • For small-scale research and development, pilot scale and production scale, AUSTAR can provide single-use formulation preparation, sterile filtration, sterile storage and transfer, and integrate single-use filling manifold and sterile connections there between. 

Solutions for PAT & QbD based Continuous Manufacturing

In biopharmaceutical industry, PAT technology is mainly applied in continuous manufacturing process, and this is the inevitable trend of biopharmaceutical process development. The continuous manufacturing process reduces labor cost with high process integration and high automation level; it can be monitored in real time, making products more reliable and reducing waste. Continuous manufacturing can achieve equipment miniaturization, which reduces the capital investment, and it is easy to adjust, which is easy to adapt to the shifting of market demand. By implementing Raman technology and PAT management system into the bioreactor platform and implementing QbD concept, AUSTAR realizes the online real-time control of biopharmaceutical process via PAT management system and automatic control system. In addition, AUSTAR invited a number of world-class experts in the field of QbD/PAT to provide clients with QbD concept consulting service and on-site technical support covering full life cycle from R&D to commercialization, so as to help users to improve their quality management system and ensure the production quality of drugs and the safety of patients.