Supply Chain
Assessment for CGT
Cell and gene therapies are distinctly different from traditional biopharma product and their supply chains require uniquely designed logistics solutions for optimal patient delivery and administration.
Helping you address complex supply chain challenges
Materials produced for autologous and allogeneic therapies must be shipped under strict temperature controls within extremely tight timelines, and with full traceability always. HiTech Health can help you address complex supply chain challenges and provide end-to-end assistance with managing all aspects to ensure the products are manufactured and supplied to patients efficiently and effectively.
HiTech Health can assist you with:
- Day-to-day management of supply chain activities.
- Coordination between CMOs, treatment centres and logistics providers.
- Supply chain risk assessments and mitigation plans.
- Selection of supply chain vendors.
- Evaluation of CGT supply chain and improvements.
- Responsible Person (RP) services for CGT.
Understanding the New EU Clinical Trial Regulation (CTR)
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
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...
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UK: +44-20-30267419
US: +1-857-3265835
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