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Analytical Services

Analytical services provide comprehensive testing and evaluation of materials and products to ensure quality, safety, and regulatory compliance.
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Analytical Services

Analytical Services

MRB Next GenTech offers extensive analytical services to support cell and gene therapies. These services ensure product quality, consistency, and regulatory compliance, focusing on the critical attributes of identity, potency, purity, and safety. Our state-of-the-art testing facilities are equipped to handle complex testing requirements across all stages of therapy development, from early research to commercial production.

Benefits:

  • Regulatory Compliance: Our services align with FDA, EMA, and other international standards.
  • Comprehensive Testing: Covering all aspects from early development to commercial manufacturing.
  • Custom Solutions: Tailored analytical strategies to meet unique project needs.
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Key Services:

  1. Analytical Method Development and Validation:
    We offer phase-appropriate method development and validation to ensure the accuracy and reliability of your assays. Our team tailors the methods to meet specific product requirements, supporting both in-process controls and final product release testing.
  2. Stability Testing:
    Conducting real-time, long-term, and accelerated stability studies, we assess the shelf life of your product under various conditions. Stability testing is essential to ensure that your product maintains its efficacy and safety throughout its intended lifespan.
  3. Material Qualification:
    We employ a risk-based approach to qualify raw materials used in the manufacturing process. This ensures that all materials meet the required specifications and are suitable for use in clinical and commercial products.
  4. Microbiological Safety Testing:
    Our microbiological testing services focus on detecting and preventing contamination in cell and gene therapies. We provide sterility testing, endotoxin testing, mycoplasma testing, and other assays to meet stringent regulatory standards.
  5. Potency Assays:
    Potency assays are critical to evaluating the biological activity of your product. We offer customized potency assays designed to measure the therapeutic effect of your cell or gene therapy product, ensuring it meets the required specifications for clinical use.
  6. Genomic Analysis:
    Our genomic analysis services support the genetic characterization of your therapy. We offer assays to confirm genetic modifications, assess integration sites, and ensure the stability of the genetic material throughout the manufacturing process.

Who Should Consider This Service:

  • Biotech and Pharmaceutical Companies: Companies developing cell and gene therapies that require reliable, GMP-compliant analytical support.
  • Research Institutions: Academic and clinical researchers involved in early-stage therapy development who need robust analytical testing to support their studies.
  • Regulatory Bodies: Agencies and organizations looking for precise analytical data to ensure the safety and efficacy of cell and gene therapy products.

Frequently Asked Questions (FAQs)

What types of products do you support with your analytical services?
We support a wide range of cell and gene therapy products, including autologous and allogeneic therapies.
How do you ensure compliance with global regulatory standards?
Our services are designed to meet the requirements of FDA, EMA, and PMDA guidelines, ensuring your product is ready for regulatory submission.
Do you offer customized solutions for unique therapy requirements?
Absolutely. We tailor our analytical services to meet the specific needs of your product, ensuring that you receive the most relevant and accurate data.