Why Cell and Gene Therapy Companies Choose Zener Engineering Services
- by Zener Engineering Services Ltd
- •
- 29 Nov, 2020
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Recent Client: '[ZES]... Will Do The Right Thing'
Cell and Gene Therapies
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 pharmaceutical 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.
Zener Engineering Services Ltd - The GMP Engineering Experts
ZES were founded on the principles of being innovative and providing world-class solutions. ZES are building a reputation for quality and excellence, with a consistently high standard of quality, reliability and versatility of its services. ZES invest heavily in highly qualified and GxP experienced personnel, to respond to the increasingly complex demands of the pharmaceutical, medical device manufacturing industries and healthcare providers.
Director David Easton said: “I’m delighted that Cell and Gene Therapy Organisations choose ZES, in some cases, even after a demanding three-stage selection process. ZES have a proven track record with Cell and Gene Therapy organisations helping Clients progress towards their ultimate goal of GMP manufacturing.
A number of contract awards provide a sound basis and further illustration of our ability to deliver excellent consultancy and services to this sector."
Whatever your requirement, ZES can provide a professional compliant engineering service, that is streamlined and suitable for its purpose, whilst accommodating your business needs.
How have ZES Supported Cell and Gene Therapy Companies Recently?
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.
- Manage suppliers and activity reviews.
- Look after the GMP Quality engineering interests of the client CGT company.
Quality and Reliability
Speed and Flexibility
FDA / MHRA Experience
Value for Money
- Expert Advice by Utilising Proven Experts
- Consistently High Standards and Service Levels
- Transition and Education for Client Staff
- Dedication and Passion from Industry Experts
- Speed and Quality of Service and Delivery. (Small or Large Projects)
- Assurance to Executives of our Credentials and Practices
- Leaders' Assistance in Assessing and Managing Risks
- Consultants with Integration Expertise
- A Fresh Perspective
- Best Practice Recommendations
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