Search Suggestions Antibody/fusion Protein Cell/gene Therapy Gmp Production Commercial Manufacturing Plasmid Virus Cell
Focusing on customers, helping customers develop
affordable and high-quality biopharmaceuticals to
patients across the world.
Focusing on customers,
helping customers
develop
affordable and
high-quality
biopharmaceuticals to
patients across the world.
Nine months from DNA sequence to
clinical sample.
One-stop Monoclonal
Antibody/Recombinent
Protein & Cellular
Gene Therapy CDMO
Service.
Share, Help, Achieve, Win-win
Nine months from
DNA sequence
to clinical sample.
Fully integrated Monoclonal
Antibody/Recombinant Protein & Cellular
Gene Therapy CDMO Services.
Share,
Help, Achieve,
Win-win
Altruist Biologics is the CDMO with the largest number of batches commercially produced in China, focusing on the development and commercial manufacturing of biopharmaceuticals including antibodies, fusion proteins, ADCs, cell and gene therapies products. Altruist Biologics is committed to "helping customers develop high-quality biopharmaceuticals that are affordable to ordinary people around the world" and is your trustworthy strategic partner.
We provide customized process development and manufacturing services, from DNA sequence construction to commercial production, to help our customers successfully overcome the challenges of CMC regulatory compliance. We have accumulated a wealth of successful experience in the fields of Antibodies/Fusion Proteins and Cell and Gene Therapy and we are committed to providing best-in-class, cost-effective and reliable services by applying our expertise and utilizing our international standard facilities to meet our client's requirements.
We have broad capabilities, professional technical team, and advanced facilities that enable us to provide support in every stage of drug development lifecycle. Whether you would like to work together on a complete gene to IND development program, or a complete BLA program including commercial manufacturing, we have the expertise to help you achieve your goals. Our service offerings can help solve potential CMC issue and accelerate the implementation of your strategy
Continuous and stable
manufacture operation
capability
4 commercialized antibody products launched domesticly and globally
700+ batches consistently manufactured
100% commercial production success rate
Sufficient manufacture
capacity
60KL in operation: 6*1KL SUB, 3KL SSB
50 L perfusion production line, 500 L perfusion production line is under construction
172KL under construction: 6*2KL SUB, 20KL SSB
Drug product filling capacity: 45,000K vials per year, 15,000K pre-filled syringes per year
Quality system of
international standards
Compliant to FDA, EMA and NMPA quality standards.
Successfully passed 40+ national and international audits
MNC
NMPA
FDA BLA RIE
EMA QP
Superior product
development capabilities
DS: Titer ~10g/L and yield ~80%
DP: Vial ( Liquid & Lyo), PFS, AIMNC
Extensive experience in China and global registration filings
NMPA IND: 30+, FDA IND / EMA IMPD: 10+,TGA EC: 3+
NMPA NDA: 10, FDA BLA: 1
Post-approved changes: 10
Industry-leading project
management system
Management of 100+ projects at different development stages
Enabled to accelerated marketing authorization of 8 products
Completion from DNA sequence to clinical sample preparation within 9 months
Continuous and stable
manufacture operation
capability
Sufficient manufacture
capacity
Quality system of
international standards
Superior product
development capabilities
Extensive experience in China and global registration filings
Industry-leading project
management system
2023-08-31
2023-01-09
Altruist provides high-quality services to global biopharmaceutical companies and drug R&D institutions. We are actively working with strategic partners and industry experts to explore more possibilities in the medicine field. Through our joint efforts, we will accelerate the pace of future medical breakthroughs that will transform the lives of patients and create a better future together.
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