Ausun Pharmaceutical Contract Development and Manufacturing (CDMO)
Ausun Pharmaceutical provides contract development and manufacturing (CDMO) services for registered starting materials, intermediates and active pharmaceutical ingredients from grams to multi-tons to support clinical development and commercial supply.
Key services include:
- Route design
- Process design
- Process development
- Analytical Development and Product characterization
- IP protection
- Small-scale kilo lab (1-20L) and pilot-scale (20-200L) production
- Small scale (100-1000L) manufacturing
- Large scale (500-5000L) manufacturing
- Qualification and validation services.
Ausun provides its customers with exclusive custom manufacturing services. The research and development efforts are optimized to allow for flexible and fast responses to customers’ needs. A streamlined decision-making process, the ability to scale up production quickly and state-of-the-art plants and equipment, operated by highly-trained employees, allow Ausun to achieve its customers’ ambitious targets. Manufacturing capacity utilization is ~ 50 – 65% and once manufacturing capacity utilization exceeds 70%, investment in additional production capacity is implemented.
We are specialized in effectively transferring R&D and lab-processes into industrial production workshop within the promised timeline and achieving the expected quality. Our capabilities in R&D are replicated in manufacture, with our global standard quality system,we could offer our worldwide partners efficient, flexible and high-quality solutions for intermediate or Active Pharmaceutical Ingredients (APIs) and finished dosage forms from preclinical to commercial.Become your trusted global partner for pharmaceutical development and manufacturing from preclinical to commercial.
Our manufacturing facility located in Taizhou City, Zhejiang Provnice with a total reactor capacity exceeding 500 m3. In addition there are 5 new workshops under construction, and we will expand our reactor capacity up to 1000 m3
With reactor volume from 20 L to 5 000L, operating in ranges from -50°C to +200 °C and pressure up to 10 bar we can accommodate a broad range of chemical processes. Highly automated units for reaction parameters monitoring and control.
Segregated clean areas with different type of equipment for isolation, drying, milling，micronization and also spray drying to adapt particle size distribution to meet customer requirement.
Flow chemistry/Continuous processing capabilities
Ausun are always looking for new opportunities to expand our manufacture capabilities and Flow chemistry/continuous processing has therefore become an essential tool for the organic chemistry. The advantages of continuous flow chemistry are Improve safety,Reduce cycle time, Increase quality and yield, allows for rapid analysis and scale-up of a chemical reaction.
Ausun has invested in flow chemistry technology,and designed the reactors together with equipment manufacturer. we established an continuous processing platform that can offering process development, pilot-scale production services to our customer.
Ausun bases its operations on well-established and proven project management processes that are consistent with a sound quality management system.
R&D Project Leaders are entrusted with the technical lead of the projects, while Commercial Managers take care of all commercial matters. Project governance is achieved by a Steering Committee, that involves the CEO (also Head of R&D) and Senior Management, that regularly monitors and controls the progress of each project in order to ensure both seamless project execution and that challenging customer requirements and high-quality standards are met. This project governance structure, in combination with highly skilled and experienced specialists, ensures the safe and reliable achievements of project objectives.
Characteristics and benefits of Ausun's Project Management
- Dedicated technical project leaders and commercial managers for project scale-up and life-cycle products
- One-site concept to ensure high flexibility and fast decision making
- Successful scale-up of > 200 process steps in 8 years
Ausun has a culture of continuous improvement with focus on improving the quality and efficiency of the production process based on the experience it has gained from close exclusive interaction with customers and the long-term relationships it has established
Sustainability is an imperative. It's the right thing to do — for people, the planet and our business. Sustainability is an engine for innovation. Integrating sustainability into everything that we do future-proofs our business to be resilient in challenging times, helping ensure we can help our customers to continue to deliver life-changing medicines to patients. With this in mind, we seek to integrate sustainability into every aspect of our business. We have the following practices in place to embed a sustainability mindset across Ausun:
- Environmental Protection
- Ethics and transparency; underpinned by Ausun’s company values of trust, respect, transparency and a win-win mind-set
- Risk Management
- Workforce engagement
- Investor relations
Quality Management – Inspection history
Ausun has a very strong Quality and Regulatory department.
At the establishment of the company our CEO hired a former FDA inspector to design the processes and the workshops with Quality in mind. The result is a clean track-record with inspections by the health authorities and high quality business processes from process development, technology transfer and manufacturing process, resulting in high quality product.
We manufacture as well the ISO-steps in a GMP environment, with a GMP mindset, the only difference being lower involvement of QA, ensure process robustness and stability without a formal process validation.
Ausun has been inspected by EU health authorities, Japanese PMDA, Russian FDA and the US FDA.
The last inspection by the US FDA in May 2018 resulted in a clean inspection-record with no 483-observatoin and a NAI rating.