Turnkey cleanroom modules

cult.tainer® – house your manufacturing process of cell and tissue products

The cult.tainer® developed by Valicare is a module measuring up to 470 square meters (5059 square feet) in which individual ATMPs (somatic cell or gene therapeutics, stem cells, or biotechnologically processed tissue products) can be manufactured in parallel in two rooms. The module contains all the rooms required for process and quality control. If required, storage, airlocks, office, and sanitary facilities can also be integrated. The cult.tainer can be extended with a cleanroom class C connection module for automated processes and closed systems.

Planning of premises and achieving GMP-compliance

Valicare can plan your premises including the calculation of the investment costs (TIC) and the system in cooperation with the design department System Integrated Solutions (SIS) of our parent company Syntegon. Accompanying the system services with the required GMP services is a great advantage for our customers.

Your advantages:

• Fully equipped and qualified GMP-compliant cleanroom according to your specifications
• Support in the development and establishment of the GMP process and system
• Support with personnel management
• Support with commissioning and start-up of manufacturing

The cult.tainer® offers turnkey GMP-compliant cleanroom modules for manual and automated cell and gene therapy production.

Would you like to shape the future with cell and gene therapeutics? We will be happy to plan and implement your process. Get in touch with us now. Together we will take your therapy to the patients.

One of our core competencies is the analysis, development, transfer, and implementation of an efficient cell and gene therapy manufacturing process under GMP conditions. We are familiar with the underlying regulatory requirements for ATMPs and take them into account at an early stage when developing the relevant processes. Once set up correctly, Valicare ensures translation into a GMP-compliant manufacturing process.

Valicare offers special services such as

• Accompanying consulting
• Risk and quality management to ensure GMP compliance
• Application for manufacturing authorization

We support you with

• Analysis, development, and description of all relevant processes
• Creation of flow diagrams
• Planning, execution, and documentation of all upcoming risk-based qualification and validation tasks
• Specification and risk-based categorization of goods, intermediate and end products

• Supplier research and qualification
• Document generation for the higher-level quality assurance processes
• Verification of cleaning procedures
• Data storage/IT concept and validation of computerized systems

• Organizational chart of responsibilities and function holders
• Master documents such as site master file (SMF), validation (VMP), and hygiene master plan (HMP)
• Vendor assignment of responsibility agreements (VAAs)
• Pharmacovigilance system (for clinical investigational medicinal products)

• Application, discussion, and support of a scientific advice procedure at the Paul-Ehrlich-Institute (PEI)
• Generation of applications for manufacturing authorization
• Execution support for the application and ethics vote of the clinical trial
• Management of investigational medicinal product logistics

In cooperation with Syntegon's SIS design department, Valicare manages the rapid construction of the cult.tainer®. The qualified and experienced Valicare engineers then carry out the qualification and commissioning of the equipment and supply systems.

Backed by all necessary competencies and by providing the regulatory functions, Valicare can - if necessary - start up manufacturing under interim management and hand over keys and manufacturing to you after the first investigational medicinal products (iATMPs) have been prepared.

Valicare will be happy to take on the recruitment, training, and induction of operational personnel in accordance with the pharmaceutical operating concept and can provide temporary personnel for key positions.

For decades, experts from Valicare and Syntegon have been taking care of topics related to cleanrooms and processes that are carried out in compliance with GMP and ISO standards. All modules designed for the production of cell and gene therapeutics comply with the requirements of the EU GMP guidelines including Annex 1. Our experts will be pleased to inform you about the standards and guidelines applicable to these modules and can explain in detail how the design, technical requirements, and requirements for raw and starting materials, intermediate and end products are taken into account. Benefit from the great flexibility of the valicare.tainer® system!

The flexibility of the cleanroom modules allows a wide range of combination variants.

Would you like to shape the future with cell and gene therapeutics? Our experienced GMP experts will be happy to support you from development to approval. Don't wait any longer and secure your customized turnkey cleanroom module for cell and gene therapy manufacturing. Together we will take your therapy to the patients.