Process Development, Supply of Pre-Clinical Materials
and Quality Control Assay Development
Our team of experts can provide comprehensive solutions and strategies for process development, quality control assay development, supply of pre-clinical and shipping studies.
Process Development and Supply of Preclinical Material
Our team will work together with you in assessing your current manufacturing process to identify potential improvements and create a process development strategy to meet your needs.
We can take your process into our R&D laboratory to identify gaps and make the process more robust.
We will work with you through the entire process and assess key parameters of the process such as starting materials, raw materials, manufacturing steps and quality control assays.
As our laboratory operates to GMP, we can also manufacture and supply pre-clinical product as required for studies to enhance the development of your product.
Our services range from establishment of preclinical or research cell banks, adherent and suspension-based cell culture, media screening and selection, bioreactor process development, harvest optimisation and controlled rate cryopreservation.
Developing and Designing Quality Control Assays
Every product needs to be tested to assess its safety and effectiveness and the design and validation of your assay is critical for the approval of your product through regulatory bodies.
Quality Control assays (in-process controls and release assays) can be a challenge when companies are starting out and deciding what is suitable for their product. Currently, there are numerous assays available for key safety assays such as sterility, mycoplasma, and endotoxin, and knowing which assay is right for your product is critical for product development and to allow quick release of your products.
Our experience and collaborations with leading companies in the field of testing, helps you determine what tests are needed to properly evaluate your product and to ensure it is aligned to PhEur and USP regulations and that you have the optimised characterisation assays for your product.
HiTech Health, University of Galway and Odyssey Validation Consultants awarded DTIF funding
The Disruptive Technologies Innovation Fund (DTIF) is a €500 million fund established under Ireland’s National Development Plan (NDP) in 2018. On Thursday 23rd November, Ireland’s Minister for Enterprise, Trade and Employment, Simon Coveney TD, Minister for Further...
Empowering Tomorrow’s Therapies: Hitech Health at Advanced Therapies Integrates 2023
Hitech Health is delighted to be attending Advanced Therapies Integrates in Stevenage, England on the 30th November. This event aims to drive the translation of cutting-edge research and disruptive innovation into the wide-spread adoption of Advanced Therapies,...
Afortiori Development and HiTech Health Forge an Important Collaboration
Afortiori Development and HiTech Health Forge an Important Collaboration to Support the Clinical Research and Product Development of Groundbreaking Cell and Gene Therapies. Galway, November 9, 2023 - Afortiori Development, a premier full-service Clinical Research...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.