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IND Development Services for CAR-T Cell Therapy

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All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.

Background Services Highlights

Empowered by extensive experience and state-of-the-art equipment, Creative Biolabs has been a world-leading custom manufacturer in the area of antibody discovery and immunotherapy. Now, we are proud to introduce our full package service of investigational new drug (IND) development for chimeric antigen receptor (CAR) T cell therapy.

Background

Cell-based immunotherapies using CAR-T cells have demonstrated high response rates in patients with B cell malignancies. Currently, this therapy is being investigated in both hematologic and solid tumor types. As more and more CAR-T cell therapies aim to move into clinical trials and become promising treatment options for more patients, IND development is required and becomes a topic for extensive discussion. However, it is challenging from the experiment design, project management, to the file preparation of each module based on regulations from Food and Drug Administration (FDA) for most scientists who are not expert at them. Therefore, Creative Biolabs, who has been in the field for years, offers the IND development service for CAR-T cell therapy to solve your troubles during the whole IND process.

The procedure of CAR-T cell therapy

Figure 1. The procedure of CAR-T cell therapy.

One-Stop IND Development Service

As an experienced company, Creative Biolabs deeply understands FDA's current requirements on this item. There are two fundamental purposes for FDA to review an IND. The first one is to ensure the safety and rights of subjects in all phases of an investigation. The second is to help ensure that the quality of the scientific evaluation of the drug is sufficient to permit an evaluation of the drug's safety and effectiveness in phases 2 and 3. A full IND development process includes the pre-IND process, the IND study protocol, preparing the initial IND submission, filing the IND, maintaining the IND. The pre-IND process is served in determining if your study qualifies for exemption from an IND. A fully developed clinical protocol is the basis for the initial IND submission. Preparing the initial IND submission includes an IND application form (contains animal pharmacology and toxicology studies, manufacturing information), a cover letter, a ClinicalTrials.gov certification of compliance. Our one-stop IND development service can free up your valuable time, helping you complete the whole IND process from the pre-IND process to maintaining the IND.

Drug development phases from research stage up to marketing.

Figure 2. Drug development phases from research stage up to marketing; NDA = New Drug Application, SNDAs = Supplemental New Drug Application.

Highlight Features of Our Service

  • Abundant Successful Cases
    Leveraging years of experience in immunotherapy, Creative Biolabs has a proven track record of successful CAR-T cell discovery projects for clients worldwide, ensuring high confidence in meeting IND requirements.
  • Time and Labor Savings
    By handling all aspects of the IND process, our one-stop service allows clients to focus on other critical aspects of their research, saving valuable time and resources.
  • Extensive Process Proficiency
    Proficient in every step of IND development, from pre-IND determination, clinical protocol development, initial IND submission, to maintaining the IND, ensuring a streamlined and efficient process.
  • Support from Pre-IND to IND Maintenance
    Comprehensive support throughout the entire IND development process, including preparing IND application forms, cover letters, and certifications of compliance.
  • Comprehensive One-Stop Service
    Offering a full package IND development service that covers everything from the pre-IND process to maintaining the IND, freeing clients from the complexities of lab experiments and regulatory requirements.
  • Customizable Solutions
    Tailored services to meet the specific needs of each client, ensuring that all aspects of the IND development process are aligned with the unique goals and requirements of their CAR-T cell therapy projects.
  • Experienced Staff
    Our team of Ph.D.-level scientists is highly experienced and well-versed in FDA regulations, including all aspects of IND development, providing expert guidance and support throughout the process.
  • Expert Project Management
    Effective project management to handle the intricate details and ensure timely and accurate completion of all IND development stages, reducing the burden on the client's internal team.

We are proficient in every process of IND Development. Choosing Creative Biolabs can certainly increase the possibility of passing. if you are interested in our service, please feel free to contact us for more information. For more details, please click CAR-T safety testing.

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