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Custom Engineering of Your Master Cell Lines! Applied StemCell is one of the longstanding, premier providers of CRISPR/Cas9 service. and a leader in genome engineering technologies. With our experience in having engineered >1300 unique cell line models in >200 distinct mammalian cell lines, for researchers worldwide, we can genetically modify any mammalian cell line using proprietary multi-approach designing and optimized protocols to your specifications:
- Customized deliverables (heterozygous/ homozygous mutations, footprint-free genome editing)
- Variety of mutations: gene knockout/ knock-in (point mutation, reporter knock-in, promoter modifications, conditional gene expression, fusion gene and more
- Generate master cell lines and isogenic cell lines
- Most comprehensive start-to-finish stem cell technology platform
Our custom service also includes high quality service with dedicated project management for timely notifications and reports.
Cell Lines Categories: Cancer, Immortalized, Stem Cell (iPSCs, ESCs) lines; CHO cells; and even Primary cells
Applications: Immuno-oncology, antibody validation, antibody discovery, antibody screening, protein screening/ evolution, isogenic master cell line generation, disease modeling, drug target discovery and toxicity screening.
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Cell Therapy Manufacturing - iPSCs & MSCs
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GMP & GMP-Like Plasmid Manufacturing
GMP-Grade GMP-Like Research-Grade Lower the cost and expedite your project timeline with Applied StemCell's complete GMP/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! 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
- From RUO to Commercial stage
- Competitive Pricing
- Research, GMP-like & GMP Grade
- pDNA formats: frozen glycerol stock or stabs for cultures
- Inquire about pDNA formats we accept
- Fully customizable service
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GMP-Grade Cell Banking
GMP iPS Cell Expansion and Banking
GMP iPSC expansion and banking refer to the process of manufacturing iPSCs (induced pluripotent stem cells) using good manufacturing practices (GMP) standards. This process involves expanding iPSCs in a controlled environment under GMP conditions to ensure the highest quality and consistency of the final product. The expanded iPSCs are then stored in a GMP-compliant cell bank for future use in research or clinical applications.
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.
The GMP iPSC expansion and banking process typically involves rigorous quality control measures, including monitoring of the cell growth rate, viability, and genetic stability. The final iPSC product is also tested to confirm that it meets the required specifications for identity, purity, and potency.
GMP iPSC expansion and banking is an important step in the development of iPSC-based therapies, as it ensures that the cells used for research or clinical applications are of the highest quality and consistency, minimizing the risk of adverse effects or treatment failure.
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
- Master Cell Bank
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Cell Therapy Manufacturing - iPSCs & MSCs
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 two comprehensive iPSC & MSC manufacturing service platforms. We provide custom iPSC and MSC manufacturing service options such as cell banking and cell product development (e.g., gene editing, differentiation, and generation). At ASC, we have the capacity to support commercial manufacturing with our safe and efficient scale-up processes.
Cell 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.
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GMP-Grade Cell Batch Testing
GMP Grade Cell Batch Testing
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.
GMP-grade cell batch testing refers to a set of quality control tests that are performed on a batch of cells intended for use in human clinical trials or commercial production. GMP (Good Manufacturing Practice) is a set of guidelines and regulations that ensure the quality, safety, and efficacy of pharmaceutical products, including cell-based therapies.
GMP-grade cell batch testing involves a series of assays and tests to confirm the identity, purity, potency, and safety of the cells. These tests include tests for sterility, endotoxin levels, mycoplasma contamination, viability, and identity of the cells. In addition, potency assays are performed to confirm the desired biological activity of the cells.
GMP-grade cell batch testing is a critical step in the manufacturing process of cell-based therapies, as it ensures that each batch of cells is of consistent quality and meets the necessary standards for clinical use. GMP-grade cell batch testing is performed by qualified personnel in a GMP-compliant facility, and the results are documented in a batch record, which serves as a record of the testing and manufacturing process.
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Mesenchymal Stem Cell (MSC) Services
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TARGATT™ Master Cell Line Generation Service
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Custom In Vivo Assay Services
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Efficacy Service with HU Models
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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Cell Line Models
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ceBE-X Custom Cell Line Model Generation
New Absolutely Zero-Off Target Base Editing Technology is now part of Applied StemCell’s Gene Editing Platform
If you are looking to edit multiple targets in a single cell with an efficiency similar to editing a single target with no off-target, ceBE-X is your choice. Applied StemCell offers the Custom ceBE-X cell model generation from your samples.
- Knockout, Point Mutation
- Completely Safe with Zero off-targeting
- Proprietary patented technology with full FTO; from RUO to cell drug development
- Novel base editor created by synthetic biology
with the highest editing efficiency on the market - In Vitro/In Vivo case studies includes iPSCs, HEK293s, ESCs, etc.
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IND-Enabling Studies
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
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
As gene editing technologies evolve, the number of potential engineered cell-based treatments continues to increase. With tools such as CRISPR and TARGATTTM, 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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Lentivirus Stable Cell Line Generation
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Virus Packaging & DNA Cloning
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Immortalization Service
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Cell Line Irridation Service