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Biobank Cold Storage Consulting – Ultra Low Temperature Storage for Biologicals

cLinical services

Bioservices

Excellence to serve your highly-valuable biological materials

Cold and ultra-cold expertise

Patient safety is a top priority, relying on both the highest levels of product integrity and security at every step. With our outstanding expertise in cold-chain management and cryopreservation, Myonex handles biostorage and operations for biological materials needing low or ultra-low temperatures. From vaccines and biomedicines (including Cell & Gene Therapies) to biological samples and starting materials used in bioproduction, we ensure every product integrity is maintained throughout clinical trials and beyond once in the market.

Clinical Services

ATMP supply chain

Partnering with Myonex you benefit from an utmost controlled and efficient supply chain for your Advanced Therapy Medicinal Products (ATMPs). Our state-of-the art and dedicated GMP French site manages import, storage, pharmaceutical packaging, QP Release, and distribution of ATMPs.

By combining comprehensive traceability with a risk-based approach, we ensure the effective and secure management of Cell & Gene Therapy products, thereby contributing to ensuring broader patient access to these new-generation medicines.

Cell and Gene Therapy Logistics – GMP Biostorage

Cell & Gene Therapy

Cell & Gene Therapy

A specific and integrated supply chain adapted to Cell and Gene therapy requirements: from importation to ultra-low temperature storage, packaging, and distribution.

  • Serving your clinical trials – and later your commercial supply
  • Full traceability, at any stage
  • With its state-of-the art infrastructure, Myonex Bailly-Romainvilliers is compliant with GMP and GDP, and authorized for the import, storage, packaging and labeling, QP Release, and distribution of both experimental and commercial Advanced Therapy Medicinal Products (ATMPs). Biosafety Level 2 products (BSL-2) and class 1 & 2 Genetically Modified Organisms (GMOs) can be handled. 
  • Security and safety, for staff and products: redundancy of security systems, communication systems, product handling and control accessories.
  • Expertise in cold-chain management to serve complex operations such as secondary packaging and labeling in vapor-phase nitrogen.
  • A secure online platform for product inventory and real-time storage temperature
Biorepository – Biobank for biospecimens, pharmaceuticals, cell and gene therapies

Biorepository

Biorepository

A secure online platform for access to your product inventory and your real-time storage temperatures

Starting materials – Bioproduction/Biomanufacturing

  • Pharmaceutical raw materials (Master Cell Banks, Working Cell Banks, Intermediate Cell Therapy Product), Drug Substances, Drug Products
  • GMP-compliant storage, at any temperature
  • Centre of Biological Resources certified ISO 9001 and ISO 20387

Immunotherapy and Vaccines

  • Adjuvant Drug Conjugate (ADC) and other immunotherapies, prophylactic, and therapeutic vaccines
  • Storage options: -80°C gas nitrogen tank (Vario technology) or -80°C mechanical freezer

Tissues and Cells

  • In addition to being a Pharmaceutical Company, our site in Bailly-Romainvilliers is authorized by the French ANSM for storage of tissues & cells, under the article L.1243-2 of the French Public Health Code (CSP)

Cell & Gene Therapies

  • Advanced Therapy Medicinal Products (ATMPs): Gene Therapy and Cell Therapy Products including CAR-T cells and NK cells, and tissue-engineered medicines
  • From -80°C to -196°C
  • Authorized for the import, storage, packaging, QP Release, and distribution
Qualified Person QP services – Bioservices for Clinical Trials

Qualified Person Services

Qualified Person Services

  • A skilled team of pharmacists to support you
  • An efficient Batch Record to release ATMPs in urgent situations
  • Batch release/QA release
  • EU QP release
  • UK QP oversight

Pharmaceutical release is undoubtedly a high value-added service for biotech companies that do not have the status of a Pharmaceutical Establishment and entrust this responsibility to their partner.
Ultra Cold Packaging – Cell & Gene Therapy Cold Chain

Ultra-cold Packaging

Ultra-cold Packaging

  • Processes which ensure maintaining the cold chain of Cell & Gene Therapy products
  • A packaging design adapted to the product’s format and dispensing
  • Secondary packaging and labeling operations carried out under very strict temperature conditions, using specific equipment: Operators work in cold rooms, on a bed of dry ice, or in gaseous nitrogen containers, depending on the product’s requirements.
  • Ultra-cold-resistant materials
  • Controlling the risk of thermal shock between the product and the packaging material during packaging operations
Ultra Cold Logistics – Clinical Trial and Pharma Cold Chain Logistics

Ultra-cold Logistics

Ultra-cold Logistics

  • Logistics adapted to Advanced Therapies, which relies on a true chain of expertise
  • From storage facilities to clinical trial sites
  • Specialized and qualified 3PLs under the watchful eye of Myonex’s experts, trained in regulations governing road transport (ADR) or air transport (IATA)
  • Traceability and permanent temperature monitoring
Disaster Recovery for Clinical Trial Biostorage

Disaster Plan

Disaster Plan

  • Anticipate, address & mitigate: Benefit from support and advice to set up or upgrade your disaster plan
  • Mirror site: leverage the Myonex biobank as your mirror site
  • In case of emergency: Thanks to preparedness and emergency responsiveness we ensure your business continuity – 365/24/7. We receive your biological materials and secure each of them
Ultra Cold Chain Consulting for Pharma and Clinical Trials

Ultra-Cold Chain Consulting

Ultra-Cold Chain Consulting

Take advantage of our ultra-cold chain consultants’ expertise to secure your biotherapies through:

  • Consulting
  • Audits
  • Training

Know more about the Myonex ultra-cold chain consulting services.

Sample Management

Myonex is your trusted partner for the management of your biological samples used in preclinical and clinical research. Our comprehensive offerings include kit assembly and logistics, sample pick-up all over the world, biostorage from ambient to -196°C, and shipments to central or specialized labs. Partnering with Myonex, you benefit from a secure online platform that gives you access to your product inventory and your real-time storage temperatures.

  • Biobanking – Sample storage for clinical trials – GMP and Non-GMP Biostorage

    Biobanking

    Biobanking

    Preserve whatever the temperature: solutions from ambient to -196°C

      • Pre-clinical and clinical research samples
      • Mid-term to long-term storage
      • Acting as your main storage facility, as well as your mirror site
      • State-of-the-art facilities, dedicated to off-line storage of your valuable biological products
      • Wide capacity of GMP storage and non-GMP storage, for Research and Development purpose, both including Biosafety Level 2 (BSL-2): Cold-rooms, freezers, LN2 tanks
      • Sample integrity: Ultimate security solution for high-value specimens
      • Within the Myonex biobank global network

     
  • Clinical Kitting Services – Clinical Trial Kit Assembly and Packaging

    Kitting

    Kitting

    Kit Assembly – For the highest quality biological samples and their traceability:

    • Sampling kit design: Advised by our specialists from the choice of your sampling materials, while focusing on patient-centricity, traceability, and cost-effectiveness
    • Purchase and expiry date management
    • Production/Kitting: Secondary and tertiary packaging operations
    • Label design and printing
    • Documents: Instructions, lab manual, requisition form, etc.
    • Distribution: Shipments of your sample collection kits, worldwide
  • Disaster Recovery for Clinical Trial Biostorage

    Disaster Plan

    Disaster Plan

    • Anticipate, address & mitigate: Benefit from support and advice to set up or upgrade your disaster plan
    • Mirror site: Leverage the Myonex biobank as your mirror site
    • In case of emergency: Thanks to preparedness and emergency responsiveness we ensure your business continuity – 365/24/7. We receive your biological materials and secure each of them

Optimizing complex supply chains

Managing a closed-loop product flow means orchestrating every critical step from pick-up at hospital of the collected apheresis bag to return of the drug to the patient after preparation and manufacturing, packaging and labeling, and quality control, requiring storage, and transport multiple times. All in record time!

Your success relies on our product flow knowledge, scheduling, anticipation and security at every stage of clinical trials and beyond. Together, we contribute to accelerating access to innovative treatments for patients.