Accelerate your Advanced Therapy Medicinal Product (ATMP) development journey with our technical & quality leadership
Our vision is to help advanced therapy medicinal product (ATMP) developers and manufacturers cure unmet medical diseases sooner.
Leverage our extensive multi-therapeutic ATMP experience, expertise and enthusiasm to support your ATMP development and site quality leadership.
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ATMP Consulting
CeutiQus offers strategic translation consultancy in innovative, biological, regenerative and advanced therapy medicinal product (ATMPs). We support the whole ATMP development life cycle with preclinical, clinical, regulatory, CMC, GMP and quality guidance.
Our ATMP services include:
– Facility design
– Product design
– Process design
– Business systems design
– Quality Management Systems (QMS) design
– Risk assessment and management
– Continuous Improvement
– GMP Auditing
– Qualified Person (QP) certification services
Get in touch to find out how we can support your ATMP development and manufacturing.
There are four main types of ATMPs or ATIMPs we help with:
1) Gene therapy products (GTMP).
2) Somatic cell therapy products (sCTMP).
3) Tissue-engineered products (TEP).
4) Combination ATMPs (cATMP).
What is an Advanced Therapy Medicinal Product (ATMP) or Advanced Therapy Investigational Medicinal Product (ATIMP)?
An Advanced Therapy Medicinal Product (ATMP) is a novel and broad type of medicine used to treat diseases by using advanced technologies that involve manipulating genes, cells or tissues.
Advanced Therapy Medicinal Products (ATMPs)
These advanced therapy medicinal products (ATMPs) are a broad class of therapies that are usually developed for the treatment of serious and life-threatening diseases, where conventional treatments are either unavailable or have failed to provide a satisfactory outcome.
ATMPs are highly complex medicines and are therefore subject to strict regulations to ensure their safety and efficacy. They require a rigorous process of development, testing, and authorisation from a regulatory authority before they can be marketed to the public.
The ATMP may be either a licensed commercially available medicine with a marketing authorisation (MA) or an investigational medicinal product (IMP), also known as an ATIMP, that is being clinically investigated in clinical trials prior to a marketing authorisation application (MAA).
What is an ATMP Qualified Person (QP)?
An ATMP Qualified Person (QP) is a person who has been named on a manufacturing license to ensure that an Advanced Therapy Medicinal Product (ATMP) is manufactured, tested, and released for use in patients in accordance with the appropriate regulations and quality standards.
The QP is responsible for certifying that each batch of an ATMP (or ATIMP) has been manufactured and tested in compliance with the requirements of the marketing authorisation (MA) or clinical trial authorisation (CTA), Good Manufacturing Practice (GMP) and any other relevant regulations of each relevant jurisdiction.
As an example, the QP must ensure that the manufacturing facility and quality management systems (QMS) are in compliance with Good Manufacturing Practice (GMP) regulations, for example, that any deviations or non-conformities are investigated and resolved.
This includes, amongst many other activities, verifying that the patient-safety critical manufacturing processes have been suitably validated, that the product has been tested for safety, identity, potency, and purity, and that the appropriate documentation has been completed and reviewed.
To become a QP, a person must have a degree in a relevant scientific discipline such as pharmacy and a significant level of experience in pharmaceutical manufacturing, testing, quality assurance, and regulatory affairs. The QP must also be registered with the relevant regulatory authority in the country where the ATMP is being manufactured or marketed.
An ATMP Qualified Person (QP), for example Dr Jasbir Rattu, is a person who has been designated to ensure that an Advanced Therapy Medicinal Product (ATMP) is manufactured, tested, and released for use in patients in accordance with the appropriate regulations and quality standards.
The QP is responsible for certifying that each batch of an ATMP (or ATIMP) has been manufactured and tested in compliance with the requirements of the marketing authorisation (MA) or clinical trial authorisation (CTA) and other relevant regulations.
In addition, the QP must ensure that the manufacturing facility and quality management systems (QMS) are in compliance with Good Manufacturing Practice (GMP) regulations e.g. that any deviations or non-conformities are investigated and resolved.
This includes verifying that the manufacturing process has been suitably validated, that the product has been tested for identity, potency, and purity, and that the appropriate documentation has been completed and reviewed.
To become an ATMP QP, a person must have a degree in a relevant scientific discipline such as pharmacy and a significant level of experience in pharmaceutical manufacturing, quality assurance, and regulatory affairs.
The QP must also be registered with the relevant regulatory authority by being named on the manufacturing license of the manufacturing facility in the country where the ATMP is being manufactured and have expert knowledge of the product and processes for which he or she takes responsibility.
Who is an ATMP Qualified Person (QP)?
Dr Jasbir Rattu has over 10 years experience as a Consultant ATMP Qualified Person (QP), with a PhD in Advanced Therapy Medicinal Product (ATMP) Design & Action and decades of industrial experience developing and manufacturing ATMPs.
The biological and Advanced therapy medicinal product (atmp) blog
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HOW WE’RE UNIQUELY QUALIFIED TO HELP YOU WITH LEADERSHIP IN ATMP MANUFACTURING EXCELLENCE
VISION, MISSION, VALUES
THE CALLING TO BIOLOGICAL AND ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS)
Over 25 years ago I made a decision to use my talents, motivations and passions in biological, medical, physical and chemical sciences, craft, design and technology and apply them to what I thought was the best and most challenging and ambitious thing I could try to do with my life: to make life-saving and life-changing medicines for unmet medical need.
Chemistry, Biology and Craft, Design and Technology were the subjects I won ‘Top of the Year’ prizes in at Wolverhampton Grammar School so I instinctively knew my greatest chance of success in life would be in doing what I love doing, what I’m naturally talented at and what am highly motivated to do.
Pharmacy is the branch of Medicine which specialises in making medicines. After a lot of career research and analysis on my best course of action, I decided to study Pharmacy to become an expert on medicines. In reality, I am more of a student today than I ever was. I’ve learned experts are continuous learners. I’ve also learnt leaders are readers.
“SUCCESS IS THE PROGRESSIVE REALISATION OF A WORTHY GOAL”
“Our mission is to make life-saving and life-changing advanced regenerative medicines for unmet medical need, by any means, be it small molecules, large biologicals, cells, tissues or organs.”
We believe greatness comes from serving as many people as you possibly can.
We do this by helping our clients make innovative ATMPs for patients with unmet medical need.
This is the clear vision of CeutiQus.
We value vision, clarity, growth and contribution.
For further information on how we can help accelerate your ATMP manufacturing success and progress, be it with consulting, coaching, training, or speaking, please get in touch below.
We look forward to hearing from you.
Contact us for help with your Biological & ATMP (product/process/facility) development & GMP manufacturing projects.
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