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Biomedical and Biotechnology

Cleanrooms and Cell Factories for biomedical and biotechnology sectors

Turnkey solutions for laboratories and production environments, with a focus on ATMPs, cell, gene therapies and CAR-T.

Biomedical and biotechnology processes require environments designed around the activities performed, equipment and contamination control requirements. In advanced therapies, coordination between process, spaces and systems plays a key role in the development of the manufacturing facility.

Mangini Life Sciences designs and delivers cleanrooms, Cell Factories and laboratories for biomedical and biotechnology applications. Its offering integrates engineering, architectural systems, HVAC and utilities, construction and qualification support, according to project needs.

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Environments for cell and gene therapies and CAR-T

Advanced therapies, known as ATMP (Advanced Therapy Medicinal Products), include medicines based on genes, cells or tissues. This field covers cell and gene therapies, such as CAR-T and tissue-engineered products. Mangini Life Sciences develops the environments and systems needed for production and laboratory activities, coordinating layout, cleanrooms, HVAC, utilities and equipment interfaces. Cell Factory specifications are defined on the basis of the process and the planned activities.

Applications

  • Cell Factories for the manufacture of advanced therapy medicinal products.
  • Environments for cell therapies and cell therapy products.
  • Environments for gene therapies and gene therapy products.
  • Laboratories and production environments dedicated to CAR-T.
Mangini Life Sciences draws on Acotec’s experience in the design and construction of Cell Factories and advanced therapies environments. This expertise supports the development of projects that bring together process requirements, engineering and construction.

Environments designed around the biomedical and biotechnology process

In the biomedical and biotechnology sectors, environments must be designed according to the process, equipment, operational flows, safety conditions and applicable standards.
For Cell Factories and facilities dedicated to advanced therapies, the design takes into account flow management, equipment interfaces and the need to segregate activities. The layout must also be able to accommodate changes in processes and technologies over time.

Key needs

Product and process contamination control
Protection of operators and the external environment, where required
Integration of layout, systems and equipment
Management of flows, differential pressures and environmental conditions
Adaptability to evolving equipment

Technical documentation to support verification activities

Related solutions

Controlled contamination environments for biomedical and biotechnology processes tailored to product and process requirements.
Integration of cleanrooms, support areas, systems and process interfaces for ATMP manufacturing activities, according to project requirements.
Technical spaces designed for research, development, analysis, quality control and specialist activities.
Environments designed to protect operators and the external environment by controlling exposure to biological agents.
Solutions that can be integrated when the project requires specific levels of protection and containment.
Scalable solutions for new environments, expansions or evolving configurations.

Control, safety and documentation for biomedical and biotech environments

The intended use and the planned activities determine the technical and regulatory framework. For ATMPs, the specific GMP guidelines are taken into account; biocontainment requirements are assessed separately on the basis of biological risk.

Standard and references

  • ISO 14644 series, for the aspects applicable to cleanrooms.
  • Microbiological contamination control criteria consistent with the process.
  • EudraLex Volume 4, Part IV: GMP guidelines specific to ATMPs. Further references are selected according to the activity.
  • Target market requirements, including FDA requirements where applicable.
  • Biocontainment level defined by the biological risk assessment and the planned activities.
  • Biosafety and worker protection requirements applicable to the project.
  • Commissioning, qualification and validation documentation and testing within the agreed scope.

Standard e riferimenti

Do you have a biomedical project, a Cell Factory or an advanced therapy environment to develop?

Tell us about the application, the planned activities and the project stage. Mangini Life Sciences will work with you to assess the requirements for environments, systems and process integration.
Request a preliminary assessment