DRUG SUBSTANCE MANUFACTURING
Capacity That Scales With You
Altruist Biologics operates cGMP facilities for clinical- and commercial-scale drug substance manufacturing. Our bioreactor capacity ranges from 1,000 L to 20,000 L, including both single-use and stainless steel options, enabling flexible biologics manufacturing tailored to your diverse project needs.
At a Glance
2,000+
Largest Number of Manufactured Batches in China
>99.8%
Batch Success Rate
180+
Global Regulatory Approvals from IND to NDA/BLA to PAC
232 kL
Premier Capacity by 2026
Preclinical Through Commercial
Our preclinical to clinical drug substance manufacturing services offer scales of 1 kL-20 kL and non-GMP pilot scales from 50 L to 500 L.
Our mammalian late clinical to commercial manufacturing services offer scales of 1,000 L to 20,000 L with both single-use reactors up to 2,000 L scale and stainless-steel technologies from 3,000 L to 20,000 L.
Tailored BLA Support
We support the preparation of your BLA/MAA and provide integrated post-launch lifecycle management, efficiently addressing CMC requirements.
Optimized Tech Transfer
We offer reliable technology transfer services to facilitate the seamless transfer of manufacturing processes from development to commercial-scale production.
Our Facilities
We operate multiple state-of-the-art facilities equipped with scalable bioreactors to support early to late-stage clinical and commercial biologics manufacturing.
Suzhou
Capacity: 60,000 L
1,000 L x 6 single-use bioreactors
Includes two seed trains and one downstream production line equipped with chromatography systems and columns, UF/DF systems, depth filtration systems, viral filtration system, intermediate hold mixers for single-use bags, and media/buffer holders for single-use bags.
3,000 L x 6 stainless steel bioreactors
3,000 L x 12 stainless steel bioreactors
Each 3,000 L stainless steel production line consists of three 3,000 L bioreactors with one seed train and one downstream production line equipped with chromatography systems and columns, UF/DF systems, depth filtration systems, viral filtration system, the intermediate/media/buffer hold tanks.
The batch production is conducted through validated recipes in the integrated automation system.
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Quality System: Passed inspections from multiple global regulatory agencies including the FDA, EMA, PMDA, and NMPA
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On-site warehousing, QC, MSAT and other supporting functions
Hangzhou
Capacity: 172,000 L
20,000 L x 4 stainless steel bioreactors
Each 20,000L stainless steel production line consists of two 20,000 L bioreactors with one seed train and two downstream production lines equipped with different scales of equipment fit for both 20,000L harvest and N-1 harvest (4,500 L), in terms of chromatography systems and columns, UF/DF systems, depth filtration systems, and viral filtration systems.
Stainless steel intermediate/media/buffer hold tanks are equipped for 20KL harvest with production control through validated recipes in the integrated automation system, while smaller-sized systems and single-use holders are equipped for N-1 harvest.
Under Construction
20,000 L x 4 stainless steel bioreactors
2,000 L x 6 single-use
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Quality System: Designed to meet FDA, EMA, PMDA, and NMPA standards
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On-site warehousing, QC, MSAT and other supporting functions
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Scaling Up? We’ve Got You.
Learn how we can support your manufacturing goals at every scale.
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