Cell Therapy Manufacturing

• GMP-Like Plasmid Manufacturing

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  Research Grade

  GMP-Like

  GMP Grade

  Lower the cost and expedite your project timeline with Applied StemCell's complete GMP-like plasmid DNA development platform. At ASC, our team can design and optimize your vector, provide expansion and banking services (working and master cell banks), and perform comprehensive QC checks prior to product delivery. 

  Whether you need plasmid DNA for your drug discovery research or pre-clinical studies, ASC has you covered! Our team of experts integrate major GMP production elements and customize your GMP-like plasmid projects, so you receive a high-quality plasmid that is similar to a GMP-grade plasmid product. If you would like to learn more about how you can start building your unique plasmid DNA, contact us today to schedule your free consultation.

  Advantages

  • Tech transfer,  optimization, cell banking with 24/7 monitoring, and adequate QC checks
  • Inquire about pDNA formats we accept
  • Fully customizable service
  • Related Services: GMP-grade and Research-grade plasmid DNA development services are also available - Inquire

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• GMP-Grade Cell Banking

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  GMP iPS Cell Expansion and Banking

  GMP cell expansion and banking services are now available. If you are looking for a secure, safe storage space for your unique cells, Applied StemCell offers cell banking with 24/7 monitoring in a state-of-the-art facility. Whether you are looking for master cell bank or working cell bank services, we can customize your service to address your project requirements.

  1. iPSC expansion from ASC's control lines (GMP- and Research-Grade)

  2. Cell banking with 24/7 monitoring. 

  • Master Cell Bank
    • Number of Vials: 50-200
    • Cell Count: 1x10^6 cells/vial
    • QC/CoA provided
  • Working Cell Bank
    • Number of Vials: 50-200
    • Cell Count: 1x10^6 cells/vial
    • QC/CoA

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• GMP Cell Manufacturing

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  iPSC Manufacturing Services For Cell Therapy

  Are you looking for an experienced, flexible GMP service provider that can help you with the development of your gene or cell therapy? As a gene and cell therapy CDMO, Applied StemCell offers a complete GMP cell manufacturing service platform for the development of allogeneic products. We provide custom service options such as cell blanking and cell product manufacturing (e.g., iPSC gene editing, differentiation, and generation). At ASC, we can produce GMP-grade cells for pre-clinical and commercial purposes, and we have the capacity to support commercial manufacturing with our safe and efficient scale-up processes.

  iPSC manufacturing is complex. You can encounter several challenges in the process of generating your cell/gene therapy, but you are not alone. ASC’s GMP manufacturing experts can work with you every step of the way. We can assist in the development of your project outline, and we guarantee detailed updates as we carry out your project until it is complete and your final product is delivered.

  Would you like to get started? Contact us today to schedule your free consultation.

  GMP Service Options

  

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  Why Applied StemCell?

  • Comprehensive GMP Manufacturing Service Platform 
    • iPSC generation, gene editing, differentiation
    • GMP-grade. off-the-shelf iPSC Line and GMP-compliant TARGATT^TM iPS Cell Line
  • Working Cell Bank and Master Cell Bank Service
  • Scale-up Services
  • ASC complies with cell processing GMP facility regulations
  • Quality control protocols based on ICH-Q5A/D guidelines 
  • ISO Class 5 and 7 (Class 10,000 and 100) clean room

  GMP iPS Cell Expansion and Banking >>

  GMP iPSC Genome Editing and Expansion

  We offer two gene editing technologies for genome editing, TARGATT^TM and CRiSPR.

  • CRISPR/Cas9 Gene Editing
    • Customer needs to obtain CRISPR license
    • ASC performs fee-for-service gene editing
  • TARGATT™ Gene Editing
    • License terms are already in place
  •  In-Process QC: Reagent QC (plasmid map/sequence), Validation (cell, gRNA, integrase), Transfection pool genotyping, and Clone genotyping

  ASC also offers GMP-like plasmid production for gene editing (QC: purity, sequence, residual host DNA/protein/RNA test, etc)

  GMP iPS Differentiation 

  At ASC, we have completed many iPSC differentiation projects, and we have the expertise to further differentiate your control or genetically modified iPSCs to committed somatic lineages (e.g., neural progenitor cells, dopaminergic cells, astrocytes RPEs, photoreceptor cells, natural killer cells, and more).

  • iPSC differentiation with a customer provides protocol
    
    • Service includes: tech transfer, engineering run and scale-up
  • iPSC differentiation with ASC SOPs
    • engineering run and scale-up
    • cGMP production 

  GMP iPSC Generation and Expansion From Customer-Requested Tissue Sample Type

  With over 13 years of stem cell and gene editing expertise, we can generate iPSCs from various human tissue types using an episomal reprogramming method.

  • Seed Bank:
    • 3 clones
    • 10 vials
    • 1x10^6 cells/vial
    • QC Characterization and CoA

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• GMP-Grade Cell Batch Testing

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  Need quality control (QC) testing for your potential cell or gene therapies? Applied StemCell offers GMP-grade cell batch testing. As a CDMO, we have well-established QC procedures. Leverage our QC capabilities and allow our team of experts to safely and efficiently conduct your safety testing. Contact us today to schedule your free consultation.

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TARGATT™ Master Cell Line Generation Service

Custom In Vivo Assay Services

• Efficacy Service with HU Models

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  Based on our world-class animal model genetic engineering technologies, Applied StemCell offers a comprehensive suite of downstream assays in mouse and rat models to validate your animal models and for drug screening. We have a multidisciplinary team of expert scientists who can design a comprehensive project plan to fit any requirement/stage of your research pipeline and for drug discovery and screening.

  • Designing and engineering research animal disease models
  • Adoptive transfers/transplantation
  • In vivo functional screening assays
  • End-of-study in vitro assays
  • Antibody efficacy testing studies for immunotherapy for cancer and autoimmune disorders

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• Dose Ranging/Biodistribution

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Cell-Based Assays

• IND-Enabling Studies

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  Cell and Gene Therapy (CGT) drugs have their unique mechanism of action and require a more tailor-made approach for drug development and regulatory approval. Starting from custom cell line and animal model generation for the targeted disease, ASC’s multidisciplinary team of experts can develop preclinical assays to determine efficacy, pharmacodynamic, dose-ranging studies, biodistribution, and develop other IND-enabling assays to measure potency (AAV potency, DNA/ RNA/ protein levels) and toxicity of the drug in multiple species samples including NHPs, immunogenicity of the drug, and more. We will work with you every step of the way including pre-IND meetings with the FDA/ respective regulatory bodies to develop the right assay matrix for your CGT candidates.

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• Drug Toxicity and Efficacy Testing

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  Make Informed Go-No-Go Decisions Early in Your Drug Development Process!

  Leverage Applied StemCell’s unique expertise in CRISPR/Cas9 and induced pluripotent stem cell (iPSC) technologies to engineer predictive and reliable in vitro disease models as an alternative to animal models for preliminary drug screening.

  Our ISO:9001 certified service platform offers full flexibility in choosing assay modules with a wide range of functional endpoints for early-stage in vitro screening of preclinical drug candidates. We have a comprehensive cell-based test battery from which you can choose assays for efficacy, safety or target discovery that suit your therapeutic pipeline. We provide the scientific expertise, accurate and efficient screening to help you make informed decisions about your small/ large molecules early in your drug development process.

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• iPSC based CAR-NK & CAR-T Assay Services

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  As gene editing technologies evolve, the number of potential engineered cell-based treatments continues to increase. With tools such as CRISPR and TARGATT^TM, it is easier than ever before to insert chimeric antigen receptor (CAR) genes into iPSCs that can be further differentiated into natural killer (NK) or T cells. While there is still plenty of cancer immunotherapy research to be done, CAR-iNK and CAR-iT cell engineering provides a great opportunity for the development of therapeutics that could potentially target and eliminate various forms of cancer. These new cell therapies could be revolutionary, but before entering clinical trials, it is important to ensure these candidates are effective and safe.

  Whether you are looking to start your in vitro experiments or in vivo preclinical studies, Applied StemCell can help you design the right efficacy, safety, or toxicity assay for your cancer immunotherapy research. ASC offers a series of customizable iPSC-based CAR-NK and CAR-T cell assay services. Our team has several years of experience working with iPSCs and iPSC-derived products, so we guarantee we can create assays that capture all your requirements and deliver detailed intermediate and final reports with essential quantitative data for your preclinical studies.

  • Fully Customizable
  • In vivo and in vitro efficacy, safety, and toxicity preclinical studies
  • In vitro Assays: humanized mouse models engineered in the U.S.A.
  • Fast & Affordable

  As a leading iPSC CRO/CDMO, we also offer iPSC differentiation services to NK and T cells from your healthy/disease iPSCs or our well-characterized control lines. Our experts can even use our proprietary knock-in technology, TARGATT™ to integrate your CAR gene(s) onto your iPSCs prior to the differentiation process. Additionally, we can assist in the optimization of your CAR design to increase expression. If you would like to learn more, contact us today or visit our TARGATT™ iPSC-iNK Platform page for more details.

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• Cellular Viability and Proliferation

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• Migration Studies

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• ELISA/ELISpot

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Lentivirus Stable Cell Line Generation

Virus Packaging & DNA Cloning

Immortalization Service

Cell Line Irridation Service