We can provide comprehensive mammalian cell line development services, including a full range of services from the selection of high-productivity, high-quality and stable clonal cell lines, to the generation and characterization of PCB, MCB, and WCB. Cell line development platform Host cell lines, including CHO K1, CHO-S and CHO K1 GS-KO. 3~4 months from DNA sequence to PCB generation. Completed 50+ cell lines development, with molecular types including monoclonal antibodies, bispecific antibodies, trispecific antibodies, fusion proteins, etc., and the highest expression amount can reach 10 g/L product titers. High-throughput platform to select cell lines fitting for either fed-batch or perfusion process. Rapid development of recombinant cell lines with clonality guarantee equipped with single-cell imager and high-throughput detector.

We have a well-established cell culture laboratory, a non-GMP pilot facility for tox batch production, and a GMP pilot facility for clinical batch production, focusing on cell culture process development, scale-up, sample preparation for tox studies, sample preparation for early-phase clinical trials, process characterization, and validation, etc. Cell culture technology platform Titer can reach 10 g/L per batch using different types of bench-scale bioreactors ranging from 2 L to 10 L. Multiple sets of DeltaV-based perfusion systems, which can support the perfusion process development. The productivity can reach 7g/L/day with stable quality profiles. The pilot facility has 20L wave bioreactor, 50L and 200L single-use bioreactors, 500L stainless steel bioreactor, a 50L perfusion production line and a 500L GMP perfusion production line (under construction) and a wide variety of advanced high-throughput process analytical technologies, available to support IND registration and early-stage clinical material manufacturing. Our in-house developed cell culture media with proprietary IP can significantly reduce production cost and potential supply risks, possessing a well-established capability for in-house media development and optimization. Following QbD principle, we accomplished process development, process characterization, technology transfer and process validation for multiple commercialized antibody projects.

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

We have built an integrated CDMO platform of plasmids, viruses, and cells, providing services from early development, new drug clinical trial application (IND), registered clinical trial samples production, and commercial manufacturing services, using advanced biotechnology to efficiently help our clients accelerate the process of translational pharmaceutical research. Services we provide: Plasmid manufacturing and quality control Plasmid manufacturing Plasmid quality control Seed preparation Fermentation Cell lysis and condense Purification platform Encapsulation, cryopreservation Safety testing Physicochemical property Concentration and purity testing Sequence identification Residual impurity LentiVirus manufacturing and quality control LentiVirus manufacturing LentiVirus quality control Stable cell line development Thawing, expansion and packaging Suspension/adherent culture Transfection, purification and encapsulation Physico-chemical testing Sequence identification Biological/physical titer Purity testing Residual impurity Safety testing Cell manufacturing and quality control Cell manufacturing Cell quality control Magnetic cell sorting and activation Virus transduction and cell expansion Harvest and packaging Automation equipment and integrated process Cell quality control Cell viability assay Purity Analysis Safety test Physiochemical identification Cell function identification