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 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.
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.
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.