Tech Transfer, Scale-Up and NPI
HiTech Health’s cross-functional expertise and dynamic team of consultants can assist with all aspects of the scale-up process to full commercial production. We place a strong emphasis on ensuring product supply is robust, high quality and cost effective.
New Product Introduction
HiTech Health has experience with all aspects of product development from pre-clinical through launch. We can help with the introduction of a new product or process to a site including:
- Structure and processes in place for successful product introduction.
- Team building.
- Project management.
- Site readiness and gap analysis.
- Timelines and metrics.
Including other areas often overlooked, such as:
- Packaging activities.
- Serialisation readiness.
Technical Transfer (TT) and Scale up
There are many process transfers during the lifecycle of products from R&D to pilot facilities and ultimately commercial scale GMP manufacturing.
We can help you ensure success with your technical transfer/process scale up including:
- Project manage the scale up and transfer of new and existing products, both to internal and external sites.
- Selecting the right partners such as manufacturing, analytical and packaging providers.
- Technical transfer planning and documentation.
- Validation master plans.
- Document templates and reports.
HiTech Health awarded with €7m government funding for 'disruptive' project HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...
HiTech Health and blood cancer charity Anthony Nolan have entered into an agreement to facilitate the development of novel cell and gene therapies. Anthony Nolan Cell & Gene Therapy Services will support HiTech Health’s supply chain through the provision of a...
HiTech Health, SextonBio and MedInstitute announce collaboration to develop and publish workflows for integrating unit operations in cell therapy manufacturing using flexible automation systems. Sexton Biotechnologies, in partnership with HiTech Health and Med...
Stay Up To Date
Connect with us to receive the latest HiTech Health and industry updates.