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.
Cell and Gene Therapies: 3 Key Supply Considerations
Personalised medicines involve an increased degree of complexity when it comes to manufacturing and supply in comparison to traditional pharmaceuticals. The Horizon 2020 Advisory Group defines personalised medicine as 'a medical model using the characterisation of...
EMA Regulation of Cell and Gene Therapies (CGTs)
Cell and Gene Therapy products and other Advanced Therapy Medicinal Products (ATMPs) have to comply with European Medicines Agency (EMA) legislation at different stages of the development process, including Good clinical practice (GCP), Good manufacturing practice...
Cell and Gene at the Abbey 2021 – Galway, Ireland
From 10th to 12th November, HiTech Health hosted ‘Cell and Gene at the Abbey’, a world-leading conference focusing on Production, Scale-up and Globalisation of cell and gene therapies. We would like to sincerely thank all the speakers, sponsors and attendees of this...
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.