Manufacturing Development

Minaris Regenerative Medicine’s manufacturing development services help you to design efficient and robust manufacturing processes for your cell and gene therapy. Keeping the ultimate goal of commercial supply in mind, we help you think beyond your current manufacturing needs to create approaches that improve the commercial viability of your products. We keep in mind four key elements of commercial viability – quality, scalability, sustainability and cost of goods – the critical drivers of successful commercial cell therapy manufacturing. 

We help you establish a phase-appropriate manufacturing process and analytical development methods that consider eventual requirements of commercialization. 

PD Grosshadern team GER Ottobrunn cell bag

Process Development

Process development for cell and gene therapies is highly complex, requiring custom-developed solutions for every product. Successful process development can, therefore, only be achieved through the application of extensive experience and expertise in all aspects of GMP manufacturing and cell and gene therapy quality control.

Our process development services include:

  • Optimization of input materials and unit processes
  • Closed processing and automation
  • Improvement of process efficiency
  • Process and product characterization and validation
  • GTP/GMP documentation and batch record development
  • Product comparability and stability studies
  • Cryopreservation protocols
  • Product storage and transportation optimization
  • 2D & 3D bioreactor upscaling

Analytical Development

Our analytical development team will work with you to create testing methods that satisfy the needs of your regulatory filings and commercial production. Our development, optimization and validation of in-process-controls and release assays include the following.

Identity

  • Flow Cytometry for surface and intracellular markers

  • Real time PCR (qPCR) for the determination of vector copy number (VCN) of genetically modified ATMPs

  • ID testing for critical raw materials in-house and at contract laboratories



Purity

  • Flow cytometry cell surface marker expression associated with unwanted/contaminating cells
  • ELISA (quantitative and qualitative) for the determination of impurities and cytokines

Potency

  • Cell-based potency assays
  • Determination of DNA concentration
  • Cell count and viability assays (e.g. Trypan Blue; AO/PI)

Safety

  • Microbiological testing (sterility, endotoxin, mycoplasma) of drug products
  • Partly in-house, partly by accredited external labs

Stability

  • Stability testing of drug products according to ICH guidelines

Material Qualification

  • Application of a risk-based approach to material qualification
  • Ensuring the highest quality materials are used in GMP manufacture