As of the end of 2023, Aton possesses experience in over 750 batches of commercial production and more than 140 batches toxic and clinical production.
Based on years of extensive experience in technology transfer, clinical production, and registration of projects such as monoclonal antibodies, bispecific antibodies, and fused proteins, Aton can help clients in efficiently completing scale-up of manufacturing processes, production of non-clinical and clinical study drug products, and IND applications with lower investment, less time, and higher fault tolerance.
By combining single-use manufacturing technology with stainless steel production equipment, Aton has established an efficient and stable production platform. For shared equipment, effective cleaning procedures and cleaning monitoring assessments can control the risk of pollution in the co-line production of different products.

• The drug substance line accommodates multiple scales of 200 L / 500 L / 2000 L
• Using a single-use bioreactor, with an efficient and stable manufacturing strategy, production can be conducted in multiple batches and scales simultaneously in stages.
• Fed-batch manufacture and end-to-end intelligent continuous manufacture, offering efficient and flexible options for different production methods.
• Rich experience, successful manufacture of 750+ commercial batches and 140+ toxic and clinical batches.

Aton possesses multiple filling lines to support the diverse formulation manufacturing needs for lyophilized, and liquid vials. It strictly adheres to cGMP aseptic drug product manufacturing requirements, providing formulation manufacturing services from development to commercialization stages.

• Possesses the capability for liquid and lyophilized vials in sizes of 2R, 6R, 10R, 20R, and 50R.
• 1ml pre-filled syringe aseptic filling capacity
• Successfully completed manufacture for 5+ commercialized finished products
• Accumulated experience in the manufacture of 500+ batches liquid finished product and 300+ batches lyophilized finished product.

Aton has established a lifecycle quality system spanning from research and development to commercial production, adhering to the fundamental principle of "quality first." This system is formulated with reference to relevant laws and regulations of major markets (China, EMA, US-FDA) and other quality guidance for drug product research and manufacture, such as those from WHO, ICH, and PDA. It aims to meet the drug approve requirements of clients with high standards across multiple terminal markets.
Aton's quality strategy is a progressive quality control, implementing varying degrees of cGMP control requirements at different stages of drug product manufacture.
Starting from the research and development phase, it gradually enhances, fully complying with cGMP control requirements by Phase III clinical trials. This progressive quality control achieves product security controls while avoiding excessive quality cost investment in the early stages, ensuring cost optimization.