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Development

Minaris Regenerative Medicine’s development services for cell and gene therapies help you design and implement efficient and robust manufacturing processes and analytical testing methods. With commercial deployment in mind, we improve the commercial viability of your ATMP products beyond your current GMP needs. We recognize the four critical drivers of successful commercial cell therapy manufacturing: quality, scalability, sustainability, and cost of goods – and therefore support you in de-risking your cell and gene therapy program.

Process Development

Process development for cell and gene therapies is complex and requires tailored solutions for each product as we focus on meeting your regulatory requirements and future commercial production. Successful process development therefore depends on experience and expertise in all aspects of GMP manufacturing of cell and gene therapy products.

Minaris Regenerative Medicine’s dedicated team of experts supports development and/or partial optimization of your process.

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Development of a GMP-compliant, robust and efficient process 

  • Selection of GMP-compliant materials
  • Standardization and closing of process steps
  • GTP/GMP documentation and batch record development
  • Process and product characterization
  • Comparability or comparative studies
  • Non-GMP Stability studies

Our process development services include:

  • Thawing (e.g., automated replacement for water bath)
    • DMSO removal •    Automated and closed washing of cell populations
    • Media exchange
    • Volume reduction
  • Automated isolation of target cell population by enrichment or depletion
  • Genetic modification 
    • Viral vector transduction
    • Electroporation (e.g., CRISPR/Cas)
  • Automated and closed cell manufacturing platform (e.g., CliniMACS Prodigy®) for isolation, buffer exchange, culture, harvest, and final formulation of cells
  • Culture of suspension and adherent cells in different culture systems (e.g., CellStack systems, culture bags, G-Rex® system)
  • Scale up to bioreactor systems (e.g., multiplate bioreactor, wave bioreactor) 
  • Formulation of cells
    • Automated concentration of cells and final formulation
    • Filling of different primary packages (cryovials, cryobags) including automated filling in cryobags
  • Cryopreservation protocols for controlled-rate freezers
This list of Minaris' capabilities is not extensive. Services may differ in different Minaris regions.

Analytical Development

Minaris Regenerative Medicine’s analytical development team works with you to develop and validate testing methods that meet the needs of your regulatory submissions and future commercial production. We help you identify the critical quality attributes (CQA) to ensure highest product quality. To do this, we offer assay development, optimization and prequalification services in preparation of validation to confirm your product’s identity, purity, potency (with multiple surrogate assays) and safety. 

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Development of IPC (in-process controls) or Release assays to address:

  • Identity
  • Purity
  • Impurity
  • Potency
  • Safety

Our analytical development portfolio includes: 

  • Supportive assays for release of starting materials
  • Cell count and viability assays
  • Expression of surface and intracellular markers with Flow Cytometry (FC)
    • Selection from internally pre-defined and easy-to-validate assays (e.g., ISHAGE, T-cells, HSPC subtypes, Residual cell types)
  • Colony-Forming Unit (CFU) assays
  • Cytokine release assays by ELISA (quantitative and qualitative) or FC
  • Cell-based potency assays
    • e.g., Treg suppression assay, cytotoxicity assays
  • Transduction efficiency by FC or single cell ddPCR
  • Vector copy number (VCN)
    Promotor activity (mRNA expression)
  • Residual virus testing for lentivector-based ATMPs

Assay Prequalification

  • Testing of validation parameters, such as robustness, specificity and/or accuracy, to show the suitability of the assay for its intended purpose.
  • Preparation of method transfer into the GMP environment and subsequent validation (GMP).

Stability

  • Stability testing of drug products according to ICH guidelines.

Material Evaluation

  • ID testing for critical raw materials (in-house and at external contract laboratories).  
  • Risk-based approach to determine use of material in GMP.
  • Use of high-quality materials during development to ensure a smooth tech transfer into the GMP environment.
This list of Minaris' capabilities is not extensive. Services may differ in different Minaris regions.

Technology transfer from non-GMP to GMP

We reduce development time and accelerate tech transfer by leveraging our knowledge and designing analytical methods and processes with GMP and commercialization in mind.

 

We offer a portfolio of platform assays (e.g., ISHAGE for CD34+ enumeration and flow cytometry-based panels for specific cell types) to accelerate your development and meet health authority requirements.

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  • To facilitate tech transfer of cell therapy processes into GMP, the equipment (non-GMP) used in process and analytical development are coordinated and aligned with our Quality Assurance and GMP Manufacturing Units.
  • We help you to establish a phase-appropriate manufacturing process and analytical method development that take into account future commercialization requirements.

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