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

Manufacturing

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Manufacturing

Tech transfer, process development, process optimization & cGMP manufacturing

CDMO Cell Therapy Manufacturing Solutions

At Bramble Bio, we specialize in offering comprehensive Contract Development and Manufacturing Organization (CDMO) services tailored to meet the evolving demands of the cell therapy industry. With extensive expertise in Advanced Therapy Medicinal Products (ATMP) and Advanced Therapeutic Investigational Medicinal Products (ATIMP) manufacturing, we are your trusted partner from preclinical development to clinical trial supply and eventual commercialization.

Our Expertise

Clinical-Grade Manufacturing Our state-of-the-art facilities ensure the highest standards for GMP-compliant production:
  • Autologous and Allogeneic Manufacturing: Customized solutions to fit personalized therapies and scalable production for larger patient batches.
  • Multi-product Capabilities: Flexibility to handle different cell types and genetic modifications within a single facility.
  • Continuous Improvement: Leveraging advanced analytics and process monitoring to drive efficiency and product consistency.

Process Development

We accelerate your path to clinical and commercial success by providing:
  • Process Optimization: Enhanced efficiency, yield, and product stability.
  • Scalable Solutions: From lab-scale proof-of-concept to GMP-compliant commercial production.
  • Tech Transfer Expertise: Smooth and seamless transition from development to manufacturing.
  • Custom Protocol Development: Tailored processes for unique product characteristics.

GMP Manufacturing

  • Bramble Bio has been at the forefront of cell therapy advancements in Europe for over two decades. With extensive expertise in GMP-compliant manufacturing.
  • Produced material for up to Phase II clinical trials.
  • Released over 2100 of GMP batches

Cryopreservation and Storage Solutions

Preserving the viability and functionality of cell therapy products is critical:
  • Controlled-Rate Freezing (CRF): Preserves cellular integrity during freezing.
  • Ultra-Low Temperature Storage: Ensures long-term product stability.
  • Cold Chain Management: Comprehensive solutions to maintain product integrity throughout global distribution.

Stability Testing Throughout Shelf Life

  • Comprehensive evaluation to ensure product quality and efficacy are maintained until the end of its expiry date.

Analytical and Quality Control Services

Analytical
Ensuring product safety, potency, and compliance is our top priority:
  • Flow Cytometry: Detailed phenotypic analysis of cell populations.
  • Potency Assays: Tailored to specific product requirements.
  • Viability and Functionality Testing: Ensures cell health and therapeutic potential.
  • Microbial Testing: Sterility and mycoplasma detection using validated methods.
  • Endotoxin Testing: Ensures products meet safety thresholds.

Regulatory Support

Guidance
Our experienced regulatory team provides comprehensive support:
  • Regulatory Strategy Development: Ensures compliance with EMA and ICH guidelines.
  • Clinical Trial Applications (CTAs) and IND Submissions: Expertly prepared and meticulously documented.
  • Quality Documentation: Detailed records to support audits and regulatory submissions.
  • Gap Analysis and Risk Mitigation: Proactive identification and resolution of regulatory challenges.

Technical Capabilities

Manufacturing Infrastructure
  • Cleanroom Facilities: 16 Grade B cleanrooms.
  • Flexible Production Suites: Capable of accommodating a range of cell types and production volumes.
  • Advanced Monitoring Systems: Real-time data capture for enhanced in-process control.

Cell Types Supported

We specialize in a broad range of cell types, including but not limited to:
  • Mesenchymal Stromal Cells (MSCs)
  • Hematopoietic Stem Cells (HSCs)
  • Natural Killer (NK) Cells
  • Dendritic Cells
  • Genetically Modified Cells: Including CAR-T and TCR-T cell therapies.

Why Choose Us?

Customized Solutions

Every cell therapy product has unique characteristics and challenges. Our tailored approach ensures that your specific needs are met at every stage of development and manufacturing.

Regulatory Compliance

We maintain rigorous adherence to global regulatory standards, helping you navigate complex compliance landscapes with confidence.

History

We have a proven track record of manufacturing for more than 20 clinical trials and serving over 7,000 patients over the past two decades.

State-of-the-Art Facilities ​

Our cutting-edge manufacturing and quality control facilities are equipped with:

  • Modular Cleanrooms: Allow for flexibility in product manufacturing.
  • Advanced Equipment: Reduces batch variability and enhances reproducibility on a larger scale.
  • Advanced Environmental Monitoring Systems and procedures: Maintains product quality and compliance.
Comprehensive Project Management

Our dedicated project managers provide seamless coordination, ensuring transparency and timely communication throughout your product’s development journey.

End-to-End Support

From initial process development to clinical trial support and eventual commercial-scale manufacturing, we stand by your side to help bring transformative cell therapy products to patients worldwide.

Partner With Us

Discover how Bramble Bio can accelerate the success of your cell therapy innovations. Let us be your trusted partner in transforming groundbreaking science into life-changing therapies.
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