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.
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of...
HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
Hitech Health's Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate's Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for...
Hitech Health Appoint Clare O’Sullivan as Global Head of Commercial
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
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.