At cellerata, we specialize in bioprocessing and product manufacturing, providing end-to-end project management solutions. Our fast and user-friendly software tools, combined with the expertise of biopharmaceutical manufacturing experts, streamline project execution. From process development and Tech Transfer to GMP manufacturing, we support projects at every stage, from lab scale to clinical and commercial scale. With a focus on Cell Therapy projects, we consider the diversity and variability of human cells, evaluating process flow, implementing GMP-compliant manufacturing platforms, and enhancing product development and launch.
Traditional medical treatments often fall short in addressing life-threatening diseases. At Cellerata, we recognize the transformative power of Advanced Therapy Medicinal Products (ATMPs), which harness the healing potential of human cell-based therapies. Our mission is to make these therapies more accessible and economically competitive.
Read More
Advanced Therapy Medicinal Products (ATMPs) encompass Cell Therapy Medicinal Products, Gene Therapy Medicinal Products, and Tissue Engineered Products. These innovative treatments have the potential to heal patients suffering from life-threatening diseases where existing medical options are insufficient. cellerata, recognizing the potential of cell-based therapies, aims to facilitate and expedite projects that greatly enhance patient survival and well-being. However, the development of Cell Therapy projects faces challenges related to biology, production capacity, resource limitations, and coordination. By providing expertise and utilizing a predictive ERP solution, cellerata supports teams in achieving their goals, fostering transparent communication, effective planning, and coordination.
Cell Therapy Medicinal Products, derived from human cells, can be autologous (from the patient’s own tissue) or allogeneic (donated by healthy volunteers). This patient-centric and personalized treatment form requires the implementation of new manufacturing technologies, process analytical technology (PAT), and analytical testing. These advancements are necessary to enhance the availability, accessibility, and economic competitiveness of Cell Therapies compared to conventional treatments like daily pills or repeated surgeries. To transform human cells into medicinal products, cellerata emphasizes the importance of establishing and managing a transparent supply chain involving qualified operators, scientists, technology and material suppliers, regulators, stakeholders, physicians, and patients. With increasing complexity during product innovation, clinical development, and patient access, cellerata brings together experienced professionals from various disciplines to maximize synergies and value. Digital Project Management solutions are utilized to support and enable these collaborative efforts.
At cellerata, we offer comprehensive project consultancy services to ensure robust project management and regulatory compliance. Our digital solutions promote transparent communication, effective risk management, and streamlined project coordination.
Project Consultancy
Partner with Cellerata and benefit from our expert project consultancy for YOUR cell therapy project. Our bridging concept covers:
• Product and Process Development
• Technology Transfer
• GMP Production
• Regulatory Compliance
• Clinical Supply
Digital Project Management
Harness the power of digital project management with cellerata. Our tailor-made IT solutions, based on lean management principles, process modeling, and manufacturing scenarios, empower you to assess, simulate, plan, and optimize processes and workflows. Benefit from our expertise in:
• Conceptual planning
• Project organization
• Risk management
• Project communication
Contact us now to discuss how Cellerata can accelerate your Cell Therapy project and drive successful outcomes using our digital project management platform.
Experience & Expertise
We have the knowledge and skills to deliver your project in a multidimensional, digital, and interactive format. We excel in navigating changing standards and requirements.
Continuous Improvement:
We systematically analyze and track project progress, helping you implement continuous improvements in processes and interactions. Our self-organizing, IT-supported system is user-friendly and promotes learning.
Optimize Manageability:
We enable our clients to optimize process manageability in a digital environment, integrating machine solutions into the human workspace.
Digitalization and Integration:
We create frameworks that facilitate the digitalization and integration of processes, incorporating knowledge and know-how at multiple levels.