Cell therapy CDMO services from development to commercial.

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ul. Dzialkowa 85, 02-234 Warsaw, Poland info@bramble.bio  +44 7796354 376

Analytical

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Analytical

Development and testing services from routine sterility to advanced potency assays

We specialize in providing cutting-edge analytical testing and method development services to advance the field of cell and gene therapies. Our scientific expertise and state-of-the-art technologies ensure the highest quality standards, enabling our clients to bring innovative therapies to market.

 

Our Analytical Services Unit is at the forefront of analytical testing and method development for advanced cell therapies. Our team works closely with clients to ensure their therapies meet the rigorous standards required for safety, efficacy, and regulatory compliance. We provide customized solutions that accelerate your journey from the laboratory to clinical success for both autologous and allogeneic therapies.

 

Our services are designed to simplify the challenges and complexities of developing advanced cell therapies by providing expert scientific support and leveraging the latest technologies. We tailor our services to meet the specific needs of each project and offer efficient timelines without compromising on quality.

Service list:

Safety testing
  • Sterility
  • Mycoplasma
  • Endotoxins
  • Adventitious virus testing
Characterization – Identity, Purity and Potency
  • Flow cytometry
  • Quantitative PCR
  • Immunoassays
  • Mass spectrometry
  • Physico-chemical testing
  • Cell culture assays

Analytical development:

We provide analytical development services for CMC purposes and according to ICH Q2(R1) and other relevant guidelines. This service consists in the development of new methods, optimization, suitability and validation. Our team works with you to develop robust, scalable, and reliable analytical methods that align with your specific cell therapy product requirements. From early-stage research to clinical trials and commercial production, we offer:
Assay Development

Custom-designed assays that meet the unique needs of your cell therapy.

Method Validation

Ensuring that your methods are reproducible and meet regulatory standards.

Stability Studies

Evaluating the shelf-life and storage conditions of your cell-based products.

Potency testing:

Potency testing is a critical component in the development of cell-based therapies, ensuring that the product delivers the intended therapeutic effect. We specialize in designing, implementing and performing robust potency assays that assess the biological activity of your cell therapy. Our advanced testing methodologies are tailored to meet the unique characteristics of your product, providing reliable, reproducible results that support regulatory submissions and clinical trials. By accurately measuring the potency of your cell-based therapies, we help you validate the therapeutic potential and ensure the safety and efficacy of your product throughout its lifecycle.

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