Altruist's Suzhou consists of a gene/cell therapy plant and a multiproduct antibody manufacturing plant. The total capacity for the antibody manufacturing plant is 60,000 liters, Altruist is the CDMO offering the largest number of commercial production batches. The facilities are designed in compliance with FDA, EMA and NMPA standards. Gene Therapy/Cell Therapy Industrialization Service 1,000m2 Development and analytical platform 1,000m2 GMP manufacturing platform Plasmid Process Development Platform Virus vector process development platform Cell Process Development Platform Analytical method development With mature plasmid process development and GMP production capacity, we are available to help customers shorten the development cycle and quickly match IND/BLA. Specific host strains can be selected according to the characteristics of different plasmid products, and the preparation and verification of seed banks can be completed following regulation requirements. We have development experiences in plenty of projects, master cutting-edge technologies, which ensures the continuous and stable supply of production materials, and helps customers establish high-level plasmid preparation technology. We can provide technology transfer and GMP production for smooth and efficient large-scale manufacturing. Our teams have mature experience in providing lentivirus process development and GMP production services to help customers shorten the development cycle and quickly match IND/BLA requirements. We also support the preparation and verification of cell bank. We offer suspension-based processes or adherent processes at various scales with downstream purification to meet versatile requirements. We can provide technology transfer and GMP production for smooth and efficient large-scale manufacturing. Based on Quality-by-Design (QbD) concept , our process development platform includes not only cell-selection, cell-stimulation, cell-transduction, cell-expansion, cell-formulation services, but also process development services. We can support the development and commercial production of CAR-T autologous product, NK cell therapeutic product and antibody combinational cell therapeutic product. Support cell banking and characterization on bank-typed cell therapy products. We provide full-stack assay method development and validation service for plasmids, viruses, cell therapy and gene therapy products, including batch release, stability studies, and product characterization, meeting customer filing needs and regulatory requirements. We develop Critical Quality Attributes (CQA) for products based on Quality-by-Design (QbD) and provide comprehensive product quality research services for cell therapy and gene therapy. Well-established platform of analytical method development and validation were built for plasmids, viruses, cell therapy and gene therapy products. Lab and Factory Facilities Lab We provide state-of-the-art P2 BSL-2 lab with dynamic cytotoxicity monitoring system (RTCA) for immune-therapy research and open lab with FACS platform and QC lab. Factory Facilities We also provide flexible and scalable manufacturing platform for GMP manufacturing (including plasmid, lentivirus and cell products). Manufacturing Scale 50 L E.coli culturing for plasmid manufacturing 25 L culturing scale for virus manufacturing At least 15 batches per month for cell therapy manufacturing

We have an industry leading project management team to support your project with timelines. We will assign a dedicated project manager to customers, and can tailor our products and services to your specific needs, budget and timelines. Services we provide Process & Method Development Cell line development, process development and validation Analytical method development and qualification QbD Quality Study and CQA Assessment Specification setting and product testing Commercial Scale Production DS GMP production 200 L, 1,000 L SUT 150 L, 500 L, 750 L, 900 L (on construction), 3,000 L, 4,500 L (on construction), 20,000 L (on construction) SST Fed-batch & continuous process DP GMP production Aseptic filling for Vials (including lyophilization) and PFS/AI Manual and automatic visual inspection, automatic packaging Quality Management System Complete quality systems Compliant with NMPA/FDA/EMA GMP requirement CMC document management cGMP training Project Management and others Project Management Process/method tech transfer IND/NDA/BLA filing Dossier preparation

Check the spelling of words
Reduce the number of queries, please try again