10031904Aseptic Cell ProcessingClosedCollaborative R&DInnovate UKPharmaceutical and drug manufacturing has remained largely unchanged for decades, manufacturing mass volume largely one size fits all therapies, most aimed at treating symptoms but not curing rare and life changing diseases. However, the last decade has seen huge progress in cell therapies and gene therapies at lab scale, known as Advanced Therapy Medicinal Product (ATMPs). These therapies have the ability to cure rare and genetic diseases, either by restoring certain sets of cells, or replacing, inactivating or introducing genes into cells to cure diseases. Within the ATMP market are cures of cancer and genetic diseases that only 5 to 10 years ago would have been thought incurable. The manufacture of ATMPs is currently very labour intensive and therefore eye-wateringly expensive. More of these therapies are moving through clinical trials and being approved by regulators meaning the manufacturing volumes will be increasing. As the ATMP market takes off, there is a need to fundamentally re-think the approach to manufacturing these very specialised, potent, high value low volume therapies. However, incumbent suppliers' equipment offering is centred around the mass production of therapies using approaches fundamentally unchanged for decades. Furthermore, the UK is currently lagging behind Europe and North America in supply chains dedicated to pharmaceutical automation and containment for manufacture. This highly valuable, growing market has the ability to create 1,000's of skilled and technical jobs in the life sciences sector and associated supply chains in the UK. 3P will design, from the ground up, an ultracompact isolator, the aim of which is to provide a plug and play system to pharmaceutical manufacturers, whilst maintaining all pharmaceutical and GMP manufacturing requirements for sterile and aseptic products. The system will contain all the necessary technology to pass regulatory approval in a way that dramatically reduces operating costs, and will be able to utilise existing factory space rather than require entire new facility construction. The technical innovation and focus of the project is on the miniaturisation of technology required for the safe containment of potent liquids, into a package that is a plug and play system. Technical uncertainty exists on the performance of decontamination cycles and airflows due to the compact size and envisaged design constraints. Packaging of the required systems and hardware will prove a challenge but will result in a significantly technically advanced product, providing barriers to entry and an established route to UK manufacture and exploitation of the system.