Cellerta contributes with virtual project management, end to end along the value chain, visualized in a software. We partner with our clients in process development, Tech Transfer and manufacturing through clinical and commercial supply.
Advanced Therapy Medicinal Products (ATMPs) are both complex and diverse by nature and range. ATMPs include Cell Therapy Medicinal Products, Gene Therapy Medicinal Products and Tissue Engineered Products. An increasing number of evolving ATMPs successfully pass Proof of Concept in early to late stage clinical trials with the potential to not only treat but also heal patients from diseases with unmet medical needs.
Cellerata recognises and celebrates the potential of ATMPs as innovative, and effective resources in advancing medical treatment. We want to enable and accelerate projects that enrich the lives of an increasing number of patients with new, innovative and powerful treatment modalities.
Cell Therapy projects must take account of factors such as biological variability within the diverse human cells as starting material, supply chain relating to raw materials, technical difficulties, reproducibility issues, capacity constraints, regulatory hurdles and the diversity of clinical applications. Transparent communication and coordination within and across organisations is critical. Cellerata brings together experts from different fields, disciplines and organisations to guarantee seamless and synergistic interaction and keep projects on track.
We successfully underpin and enable projects by utilising a bespoke digital IT solution. This facilitates transparent and effective planning, communication and coordination within the project team.
Cellerata draws on an extensive network of specialist CDMOs, experts in the field, suppliers and clinical sites. The unmet needs of the patients waiting for breakthrough treatments is always at the forefront of our minds.
Cell Therapy Medicinal Products originate from human cells of patient’s own tissue (“autologous”) or healthy volunteers who donate cells (“allogeneic”). Cell Therapy is the most patient-centric, personalized, individualized form of treatment available. Cellerata recognizes that transforming human cells into a medicinal product requires the establishment and management of a supply chain from tissue to final Cell Therapy product. Stakeholders involved include the Clinic, the Pharmaceutical Manufacturer, diverse Suppliers, external Analytical Labs and Regulatory Bodies.
Due to the diversity and complexity of cell types as starting material, many experts and resources need to come together to deliver a unique and effective medical solution. This includes Manufacturing Platform, Process Technology, Analytical Method and Medical Doctors, Process Engineers, Quality Control Scientists, Quality Managers and Supply Chain Experts. Cellerata brings together passionate and experienced professionals from all the diverse fields and disciplines to generate maximum synergies and value, supported and enabled by our bespoke digital IT solutions.
Project Consultancy
Cellerata and its partnership experts and consultants provide project consultancy for the performance of planned processes:
• Development concepts
• Technology Transfer
• GMP production
• Regulatory Compliance
Digital Project Management
We introduce, integrate and apply a tailor-made digital IT solution based on project modelling and planning scenarios. This enables to simulate, assess, plan, communicate, coordinate, report, analyse, optimize work flows and resources:
• project organisation
• conceptual planning
• risk management
• project communication
Digital Project Management
We introduce, integrate and apply a tailor-made digital IT solution based on project modelling and planning scenarios. This enables to simulate, assess, plan, communicate, coordinate, report, analyse, optimize work flows and resources:
• project organisation
• conceptual planning
• risk management
• project communication
Digital Supply Chain Integration
We implement the product, processes, resources and information flows in a value stream analysis using our digital software approach. The value stream analysis is an integral part of your digital strategy or as stand alone. We integrate:
• raw materials
• production process
• information flow
• resource planing
Cell Therapy projects are complex in nature due to the diversity and biological variability of human cells as starting material. This includes, amongst other, stem cells and immune cells. Diverse manufacturing platforms, process technologies and analytical methodologies also need to be considered.
Cellerata brings together passionate and experienced biomanufacturing experts. We create value for our clients with process solutions, project management and digitalization of supply chain
We at cellerata have the experience and expertise to drive and deliver your project as a multidimensional, digital and interactive format.
We transform your project in a challenging context of ever changing standards and requirements.
We systematically analyse and track project progress and help you to implement continuous improvements in processes and interactions as a learning organization. We enable our clients to optimise the manageability of processes in a digital environment and the integration of machine solutions in the human workspace.
We create the frameworks that enable you to integrate and digitalize processes with knowledge and know how at multiple levels.
We look forward to discussing the successful delivery of your project at the intersection of bioprocessing and medicine.