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.

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