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Solutions for Cell Therapy Development

Cell therapy is a groundbreaking approach to treating a variety of diseases by utilizing the regenerative capabilities of living cells. This innovative field has gained momentum, offering hope to patients with previously untreatable conditions. Central to this progress is cell therapy manufacturing, involving the preparation and production of therapeutic cells for clinical use. Cell therapy involves using living cells, often from patients or donors, to restore, repair, or replace damaged tissues, including stem cells, immune cells, and genetically modified cells. It holds promise for conditions like cancer, autoimmune diseases, and neurodegenerative disorders.

To support the development and commercialization of cell therapies, we offer a wide array of high-quality solutions throughout the cell therapy development pipeline. Starting from discovery and development and to the adoption of cells in the clinic, our solutions are designed with flexible enough to support your innovation, grow alongside therapeutic manufacturing, and scale-up when entering commercialization.

Explore Solutions for Cell Therapy

Cell Therapy Solutions

Discovery & Development

  • Discovery & Development
  • Immunization
  • Antibody Screening
  • Vector Construction
  • Modification Detection

Discovery & Development

Discovery_Development
The cellular modification design and development of cell therapy drugs are in the early stages, covering several key aspects. These include the discovery of single-chain antibodies (scFv), the properties of functional components, and the methods of introducing these components into cells. These are crucial for ensuring the safety, specificity, and functionality of the product.
Immunization
Animal immunization is an early stage in drug development, and high-quality immunization antigen proteins are crucial for immunization success.
  • CAR Target Proteins
  • MHC-peptide Complex & Custom Service
Antibody Screening
Screening high-quality single-chain antibody (scFv) candidates can significantly increase the probability of successful development of cell therapy drugs.
  • CAR Target Proteins
  • Biotin-labeled CAR Targets
  • MHC-peptide Complex
Vector Construction
Viral vectors are a critical part of genetically modifying immune cells to express CAR receptors and maximize cell therapy efficacy.
  • GENPower CRISPR/Cas Enzymes
  • GENIUS™Nuclease
Modification Detection
The successful expression of CAR/TCR provides a robust signal for the subsequent CMC (Chemistry, Manufacturing, and Controls) stage of translation, requiring complementary detection tools for confirmation.
  • CAR Proteins for CAR Express Detection
  • MHC-peptide Complex for TCR Express Detection

CMC-Manufacturing

  • CMC-Manufacturing
  • Vector Manufacturing
  • Cell Activation
  • Cell Culturing
  • Large-Scale Manufacturing

CMC-Manufacturing

CMC-Manufacturing
CMC manufacturing is a critical phase in the development and production of cell therapy. It requires adherence to strict quality control and regulatory standards. The process must follow established guidelines, such as Good Manufacturing Practices (GMP), to ensure product safety, efficacy, and consistency. Documentation, data integrity, and traceability are essential aspects of CMC manufacturing to maintain product quality and integrity throughout the entire production process.
Vector Manufacturing
Viral vectors are a critical part of genetically modifying immune cells to express CAR receptors and maximize cell therapy efficacy.
  • GMP GENPower CRISPR/Cas Enzymes
  • GMP GENIUS™ Nuclease
Cell Activation
The use of in vitro-induced activated lymphocytes for adoptive immunotherapy has become a hotspot. Activating agents are commonly employed to simulate the in vivo signaling process and activate cells.
  • ActiveMax® Activation Beads
  • Activation Antibody
Cell Culturing
Cell culturing in cell therapy manufacturing is a vital step. It involves growth factors and other tools to assist with iPSCs, MSC, neural cells, organoids and much more!
  • T Cell Culturing
  • iPSCs Induction and Differentiation Culturing
  • Stem Cell Differentiation Culturing
  • Organoid Culturing
  • Xeno-free Cell Culture Matrix Proteins
Large-Scale Manufacturing
Scale-up your current manufacturing with us! We can scale up our GMP-products in accordance with your needs starting from g to kg of GMP-grade products.
  • GMP-grade Raw Materials
  • Custom GMP Services

CMC- Quality Control

  • CMC- Quality Control
  • CAR & TCR Detection
  • Residual Detection
  • Potency Assay

CMC- Quality Control

CMC-Quality Control
Quality control in cell therapy spans all steps from research and development to clinical applications. Cell quality control places particular emphasis on the stability of preparation processes, multi-batch validation, comprehensive quality control, and adherence to strict Standard Operating Procedures (SOPs). It involves stable quality inspections and release testing standards throughout the entire process.
CAR & TCR Detection
Detection of CAR or TCR expression is critical in evaluating the efficacy of your cell modification. Explore our products designed to help you evaluate CAR & TCR detection expression.
  • Fluorescent Labeled CD19
  • Fluorescent Labeled BCMA
  • Anti-FMC63 Antibodies
  • Star Staining - Fluorescent Labeled Proteins
  • Anti-G4s Linker Antibody
  • MHC-peptide Complex & Custom Service
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Residual Detection
Manufacturing biologics is a complex process that can introduce a wide variety of residues that can compromise the safety of the final therapeutic. Use our resDetectTM kits to detect for residues and ensure that your therapy is ready for the clinical stage.
  • Residual Detection
  • Residual Host Cell DNA / RNA Detection Kits
  • Residual Enzyme Detection Kits
  • Residual Cell Culture Materials Detection Kits
  • Residual Antibiotics Detection Kits
  • resDetect™ Manufacturing Process Residue Detection Solutions
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Potency Assay
Potency assays are a critical part of evaluating therapeutic efficacy against the target it was developed for. Use our kits to quickly study your therapeutic potency.
  • Cytokine Release Assay
  • Multiplexed Cytokine Assays
  • ActiveMax® Target-specific Activation Beads

Preclinical Studies

  • Preclinical Studies
  • Preclinical Model Selection
  • Pharmacokinetic Studies
  • Pharmacodynamic Studies
  • Immunogenicity Studies
  • Toxicity Studies

Preclinical Studies

Preclinical Studies
The objective of a preclinical program for an investigational product is to support a conclusion that it is reasonably safe to administer the product in a clinical trial. Preclinical studies encompass in vitro efficacy research, in vivo efficacy research, tissue distribution studies (pharmacokinetics), in vitro safety studies, and in vivo safety studies, among others.
Preclinical Model Selection
Simulating aspects of the pathogenesis, pathological processes, treatment methods, etc., of human diseases helps in the clinical evaluation of drugs.
  • Organoid Culture Cytokines
Pharmacokinetic Studies
Pharmacokinetics is a major component of evaluating drug efficacy throughout cell-based or animal models. For cell therapies, PK assays are designed to evaluate the presence of CAR cells post-therapeutic delivery.
  • Anti-FMC63 Antibodies
  • Star Staining - Fluorescent Labeled Proteins
  • Anti-idiotypic Antibody Development
Pharmacodynamic Studies
Pharmacodynamics is complementary to pharmacokinetics, which observes the mechanism of action of each therapy. We offer a wide variety of cell-based models and other life science tools to accelerate your PD studies.
  • Cytokine Release Assay
  • Multiplexed Cytokine Assays
  • Organoid Culture Cytokines
Immunogenicity Studies
Even CAR cells are immunogenic, despite its patient-derived origins. Evaluating the immunogenicity of any therapeutic is critical in ensuring safety.
  • Anti-FMC63 Antibody
  • Immunogenicity Anti-FMC63 ELISA kit
  • Anti-idiotypic Antibody Development Service
Toxicity Studies
A big side effect of CAR therapies is cytokine release syndrome. Ensuring that the therapy is not toxic is a priority to any therapy during the preclinical and clinical stages.
  • Cytokine Release Assay
  • Multiplexed Cytokine Assays

Clinical Studies

  • Clinical Studies
  • Efficacy Evaluation
  • Safety Evaluation and Monitoring

Clinical Studies

Clinical Studies
Clinical research is divided into exploratory and confirmatory clinical trials. The exploratory clinical trial phase focuses on the safety and tolerance of cell therapy products. The biological activity range or optimal effective dose of cell therapy products is determined through dose exploration. Another purpose in the exploratory clinical trial phase is to conduct a preliminary evaluation of product activity, such as cell proliferation, survival, and biological distribution in vivo (such as pharmacokinetics), pharmacodynamic activity (such as cytokine levels after product infusion), immunogenicity, and efficacy such as tumor remission or other types of clinical improvement, etc.
Efficacy Evaluation
The evaluation involves assessing the in vivo proliferation, survival, and biological distribution (such as pharmacokinetics) of the drug, as well as pharmacological activity (such as cytokine levels after product infusion).
  • Anti-FMC63 Antibodies
  • Star Staining - Fluorescent Labeled Proteins
  • Cytokine Release Assay
  • Multiplexed Cytokine Assays
  • Organoid Culture Cytokines
Safety Evaluation and Monitoring
Throughout the entire drug development lifecycle, safety assessment and monitoring are crucial steps, serving as key milestones for the drug's progression towards commercialization.
  • Anti-FMC63 antibody
  • Immunogenicity Anti-FMC63 ELISA kit
  • Anti-idiotypic Antibody Development Service
  • Cytokine Release Assay

Resource

Discovery & Development

Developing the Next Cell Therapy

Unveil the transformative world of cell-based treatments. Explore the latest innovations, practical guidelines, and regulatory insights in this comprehensive guide to cutting-edge medical solutions.

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Resource Center

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  • Background
  • Discovery & Development
  • CMC-Manufacturing
  • CMC- Quality Control
  • Preclinical Studies
  • Clinical Studies
  • Resource