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CELL AND GENE THERAPY

Product development support and investigation services for optimal productivity and quality

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CELL AND GENE THERAPY

See what Minerva can do for you
Accelerate your time to market

Align and standardize your development activities with Minerva’s integrated product development support. Minerva’s SME team with manufacturing, quality, visualization, and digitalization experience will facilitate low-risk, fast decision making for a fully compliant product development of your advanced therapies.

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Subject matter experts (SMEs) with extensive manufacturing and quality experience

Benefit from our SMEs’ experience working with thousands of batches in manufacturing phases like apheresis collection, activation, transduction, expansion, formulation, and cryopreservation, and laboratory tests like cell count and viability, potency, and purity analysis, among others.


Visualization tools for easy process understanding

Improve understanding and communication of complex processes through visual models enabling alignment, better decision-making, collaboration, and risk reduction.


Advanced digital technologies for quality management

Give your team the tools to manage quality-relevant information in databases, facilitating the identification of gaps, strengths, and opportunities, and risk-based decision making.


Knowledge management for compliance with ICH Q9

Convert your process information and experience into digital knowledge for optimal pharmaceutical quality risk management and sustainable GMP compliance consistent with ICH Q9.


Process mapping and characterization for quality risk management

Implement a highly visual, digital risk assessment framework to identify, evaluate and mitigate risks across all development phases, ensuring all decisions are risk based.


Swiftly resolve your technical and quality issues

Combine our technical and quality investigation capabilities throughout all your development stages and operational areas to have continuous phase-appropriate response, resolution, and reduction of issues.

Learn more about Minerva’s C3 technical investigations and R3 quality investigations here.

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Phase-appropriate investigations throughout the development life cycle

Address issues and opportunities with combined technical and quality investigations throughout process development, GMP process definition, commercialization, and continuous improvement, provided by the Minerva multidisciplinary team.


Investigations covering all your operational areas

Reduce quality issue recurrence with an integrated investigations approach for manufacturing, quality control, quality systems, materials management, supply chain, among other operational areas.


Realize your automation initiatives in manufacturing and quality

Bridge your present process and your automation aspirations for advanced therapy medicinal products (ATMPs) with Minerva’s technical support. Minerva’s SME team with combined process, automation, and robotics experience will facilitate the transition from manual operations into practical, automated, and robot-assisted manufacturing and quality processes.

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SMEs in advanced therapies and robotics

Achieve an automated process that fits your advanced therapy manufacturing needs with our SMEs that have combined experience in advanced therapies, automation modeling, and robotics implementation.


Process information gathering and digitalization for automation

Capture and digitalize your combined scientific, manufacturing, and quality data the Minerva way to ensure the correct baseline and structure for automation is in place, for outcomes that are right the first time.


Advanced robotics applications in your ATMP processes
  • Enhance manufacturing processes by integrating cutting-edge robotics technology and teleoperations.
  • Combine robotic automation with human expertise to improve productivity, scalability, and quality control standards.
  • Manage processes remotely from anywhere in the world, facilitating seamless integration and operational efficiency.

Our commitment

Advancing cell and gene therapy manufacturing and quality with innovative solutions and technologies.