The life-science industry is undergoing significant change across all life-science disciplines, including ground-breaking results in personalised medicine from new Cell and Gene Therapies.
These changes are expected to impact the whole life-cycle of a pharmaceutical product, from research to patient delivery. Industry leaders must employ new solutions to deliver commercially viable products, applying new manufacturing concepts (e.g. scale-out or easy-build modular facilities) to keep up with new technologies and a shifting market.
New start-ups and R&D companies need to be more engaged with their design partners in defining their core processes and key quality requirements to achieve cGMP approved products.
Scitech has expertise in process and facility design, quality assurance and regulatory services. We work closely with industry leaders to offer bespoke turnkey solutions for laboratories, pilot plants, and cGMP facilities.
Through concurrent and efficient design process Scitech can help Cell and Gene Therapy companies with the following:
- Leading bioprocess design and process mapping including detailing manufacturing systems and system selection, process modelling, process scheduling, capacity and operation planning, COGs analysis.
- Review of available manufacturing systems including closed cell processing and separation units, fill and finish systems, single use platforms, products transfer and automation philosophy.
- Developing key process data and critical quality parameters and attributes for manufacturing operation and define control strategies (e.g. temperature, contamination, hold times, fluid transfer).
- Leading safety and GMP risk assessments, FMEA and HAZID/HAZOP.
- Define, size and install critical and compendial utility systems having established the most compliant, energy efficient and cost-effective solution.
- Design and develop a manufacturing facility that fits the process and material/product flows, through developing schedule of areas, room layouts, adjacency diagrams with GMP and safety requirements understood and defined from concept level through to PPQ.
- Defining, installing and qualifying engineering controls including containment, waste treatment, HVAC and mechanical systems to achieve BSL-2/3 facilities.
- Develop suitable aseptic technologies and solutions where required during the manufacturing process.
- Review and establish strategies for scale-up or scale-out for large scale manufacturing.
- Qualification of cold chain platforms including storage equipment and transportation.
Get in touch today to discuss your next steps with the Scitech team.