中文

AUSTAR has extensive experience in biotechnology and provides full life cycle products and services to leading biopharmaceutical enterprises and research institutes worldwide. Whatever stage your product or project life cycle is at, AUSTAR can provide you with an integrated solution of consultancy, design and production process systems, from R&D, clinical to commercial scale and from project evaluation, implementation to continuous operation. With its capabilities for design and manufacturing of both stainless steel systems and single-use systems, AUSTAR can provide customized integrated solutions for stainless steel system, single-use system or Hybrid system according to users' production and process requirements to the greatest extent, so as to achieve the perfect balance of process flexibility and investment cost. We specialize in serving the fields of recombinant protein drugs, antibody drugs, vaccines and blood products etc.Based on our deep understanding of regulatory requirements and practice guidelines of pharmaceutical industry, AUSTAR conducts compliance review and control at each phase of the project from design, manufacturing to verification. AUSTAR also follows good engineering practice (GEP) and good documentation practices (GDP) during the entire project, forms a complete set of project engineering documents and quality documents to satisfy the end users’ GMP compliance requirements. 

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Consultancy & Services

At different stages of planning, implementation and operation of bioprocess system, AUSTAR provides process technology consulting, project feasibility study, investment budget and operation cost analysis, process concept design, process basis design, detailed design, validation and verification of process system, life cycle management and other comprehensive technical services. Combined with GMP compliance consulting and auditing, we can ensure that process requirements are met in an economical and compliant manner. For application of single-use system, we provide comprehensive and professional consulting and services from system risk assessment consulting to compatibility verification and testing.

System Solutions

With the ability of designing and manufacturing both stainless steel and single use systems, we can offer the most flexible 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.