Analytical Development Service

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

Introduction

The era of precision medicine has ushered in promising therapies like Chimeric Antigen Receptor T-cell (CART) therapy, revolutionizing the landscape of cancer treatment. At Creative Biolabs, we have been at the forefront of this transformative shift for over 20 years, bringing a wealth of expertise in analytical development to support CART CDMO services. Our focus on robust analytical methodologies ensures that our partners can navigate the complex regulatory environment with confidence, minimizing time-to-market and maximizing therapeutic efficacy.

Analytical Development for CART CDMO

Analytical development in CART CDMO is crucial for ensuring the safety, efficacy, and quality of cell-based therapies. At Creative Biolabs, we focus on analytical development and validation to meet strict regulatory requirements. Our methodologies are designed to be robust and reproducible, facilitating a seamless transition from preclinical development to clinical manufacturing.

By implementing state-of-the-art analytical techniques, we can accurately characterize CART products, ensuring they meet all regulatory and quality specifications. This comprehensive approach supports our partners in achieving reliable and consistent product performance, which is vital for successful regulatory submissions and commercialization.

Service Content

Creative Biolabs offers an extensive suite of analytical development services specifically tailored for CART CDMO. These include:

Method Development

We develop robust and reproducible analytical methods to assess the quality of CART products. Our methods are tailored to meet the specific requirements of regulatory authorities .

Characterization

Detailed characterization of CART cells is essential for understanding their behavior, potency, and safety. We utilize state-of-the-art techniques like flow cytometry, qPCR, and ELISA to provide comprehensive characterization data.

Safety Testing

Ensuring the safety of CART products is paramount. Our safety testing protocols include assessments for cytotoxicity, sterility, endotoxin levels, and the presence of replication-competent viruses.

Validation

We validate analytical methods to ensure that they are appropriate for intended purpose. Our validation processes comply with ICH Q2 (R1) and other regulatory guidelines.

Release Testing

Before releasing CART products for clinical use, we perform rigorous testing to confirm their identity, potency, purity, and safety.

GMP Release and Stability Testing

We conduct stability studies under GMP conditions to ensure that our CART products maintain their efficacy over time.

Comparability Studies

Comparability studies are essential when making changes to the manufacturing process. We ensure that the products produced by the new process are comparable in quality to the original products.

Our Analytical Development Capabilities

Creative Biolabs employs a team of highly skilled scientists with decades of experience in analytical development. Our capabilities include:

Qualified Standard Assays

We employ qualified assays to quantify the potency, purity, cell number, and viability of CART cells. These assays are essential to ensure the consistency and quality of the final product.

Custom Assay Development

We develop custom assays for viral vectors and immunotherapies, ensuring that our analytical methods are tailored to meet the specific needs of each project.

Automated Platforms

Our high-throughput development and screening platforms allow us to perform rapid and accurate analytical testing, reducing time and cost.

Advanced Characterization Techniques

We utilize advanced techniques such as flow cytometry, qPCR, RT-qPCR, ELISA techniques to provide detailed characterization data.

Safety and Efficacy Testing

We perform a comprehensive panel of safety tests, including cytotoxicity, sterility, endotoxin levels, and the detection of replication-competent viruses.

Frequently Asked Questions

Q1: What are the Key Challenges in Analytical Development for CART CDMO?

A1: One of the primary challenges is ensuring that analytical methods are robust and reproducible across different production batches. Additionally, meeting stringent regulatory requirements while optimizing the manufacturing process can be complex.

Q2: What safety tests do you perform on CART products?

A2: We perform cytotoxicity tests, sterility tests, endotoxin level assessments, and tests for replication-competent viruses to ensure the safety of our CART products.

Partner with Us

By choosing Creative Biolabs as your partner, you can be confident in the quality, safety, and efficacy of your CART therapies, backed by our extensive expertise and commitment to excellence.

Expertise: Over decades of experience in analytical development and CART CDMO services.
Comprehensive Services: From method development to validation and GMP release testing, we offer end-to-end solutions.
Regulatory Compliance: Our methods are designed to meet all regulatory requirements, ensuring a smooth path to market.
Cost-Efficiency: Optimized processes and robust methods reduce time-to-market and overall costs.