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Cell and Gene Therapy (CGTs) companies are transforming the discovery of new therapies to fight disease. The CGT approach to new therapy discovery produces a relatively new category of medicine, the full potential of which has not yet been fully realised.

CGTs are different from the usual chemical pharmaceuticals in that they involve extracting living cells, proteins or genetic material (DNA) from a patient, which are then altered in some way to provide a highly personalised therapy. This personalised therapy is then injected back into the patient. In some quarters it is suggested that CGTs may offer longer-lasting benefits than those provided by traditional chemical medicines.

Research into CGTs shows that they have the potential to treat often complex diseases, where no effective treatments are available from traditional chemical pharmaceuticals.

ZES continue to help CGTs along their product development journey and have a strong track record of working in the sector. ZES work to solve problems and accelerate successful GMP outcomes that generate health for our clients' patients. These activities include, but are not limited to:

• Process Scale up
• Gap Analysis and Risk Assessments highlighting areas for improvement
• Lease agreement review
• Mentor in GMP engineering culture approaches and practice
• Review maintenance approaches, including critical calibration tolerances
• Mentor in GMP Validation, including CSV
• Development of documentation to GMP standards
• Mentor in technical engineering issues
• New facility design reviews from a technical GMP-level perspective
• Project management
• Review supplier maintenance activities
• Look after the GMP Quality engineering interests of the client CGT company
• Supplier documentation reviews
• Validation