Advanced Therapy Medicinal Products
The rise of Cell & Gene Therapy and other Advanced Therapy Medicinal Products (ATMP) heralds a new era in healthcare. Novel medicines based on genetic engineering, innovative cell-based therapies and tissue-engineered products are increasingly providing treatment and prevention options to address areas of unmet need and facilitating more patient-centric approaches.
The UK is recognised as a world leader in ATMP research; however, manufacturing capacity of this technology has traditionally been low due, in part, to its complexity, cost and the difficulties associated with the scaling-up and scaling-out for commercialisation.
Scitech can help address these challenges. Our expert team of bioprocess engineers, process architects, within the biotechnology sector delivering tailored Good Manufacturing Practice (GMP) and containment projects that are compliant, cost effective and flexible. Our subject matter experts will use their detailed know-how to deliver and oversee every stage of your project from the design of a facility to the selection of hardware and software, while ensuring all regulations are met and the project is built to be scalable.
In accessing our services, you will benefit from:Read more
- Depth and breadth of knowledge. Our in-house team have been working in biomanufacturing and have undertaken high profile projects within the industry for many years. This has led to in-depth knowledge that we are constantly developing while applying to all assignments.
- Scale-up & scale-out. We have specific expertise in bioprocess design, scale-up & scale-out, and operational and manufacturing reviews for aseptic processing either in an open cleanroom, isolator technology or grade A cabinets for handling critical raw materials and products.
- Specialist design support. We have extensive experience providing engineering design support for sizing and selection of critical utilities (WFI/PW/Clean Air/Pure Steam), medical gases, cryogenics, waste treatment, and building and environmental monitoring systems (EMS/BMS), HVAC and other mechanical systems according to BSL-1/2/3 standards.
- C Our detailed understanding regarding containment requirements for viral vectors and/or cleanliness principles for ATMP manufacture means that we can help you to ensure your facility, whether it is single or multi-product /multi-modal, is fully compliant.
- Our in-house Qualification and Validation team can support your compliance through all project stages, from initial strategy and planning through to protocol generation, execution and reporting.