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.

dr jasbir rattu advanced therapy medicinal products atmp biopharmaceuticals biologicals qualified person qp expert

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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.

 

Patient being treated with ATMP in hospital bed

 

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.

 

 

Dr Jasbir Rattu Expert ATMP Qualified Person QP

The biological and Advanced therapy medicinal product (atmp) blog

 

Find out about the latest advances in ATMPs with our ATMP-focused blogs.

HOW WE’RE UNIQUELY QUALIFIED TO HELP YOU WITH LEADERSHIP IN ATMP MANUFACTURING EXCELLENCE

Qualifications for ATMPs
Our leader Dr Jasbir Rattu is a professional and reliable mastery-committed medicines expert and leader who can support, lead and inspire your team. He has over 25 years of continuous education in Pharmaceutical sciences with a professional background (Pharmacy) focusing and specialising in making medicines; providing both depth and breadth of foundational knowledge and rare combinations of skills in pharmaceuticals. His highly sought after expertise is founded on a thorough and never-ending continuous education and professional development. The adept application of his knowledge in pharmaceuticals, with passion and commitment enables him to consistently deliver great results.
Consultant QP in Advanced Therapy Medicinal Products (ATMPs)
Consultant QP to cutting-edge ATMP clients. Experience, education and qualifications at the cutting edge of medical/pharmaceutical sciences.
Recognised Expert in Pharmaceutical Biotechnology and ATMPs
Jasbir is a recognised expert in Pharmaceutical Biotechnology and ATMPs. He teaches and speaks on Pharma Biotechnology and ATMPs in both academia and industry as a University lecturer, corporate educator, consultant and frequently invited conference speaker.
PhD in Advanced Therapy Medicinal Product (ATMP) Design
Excellent foundation to the basic and applied science of making biological and advanced therapy medicinal products (ATMPs). Proven ability to learn, think, apply knowledge, teach, creatively add value and solve problems at the cutting edge and make difficult decisions.
Broad Experience & Critical & Lateral Thinking Ability
Breadth of scientific and technical knowledge and its application (experience) across hundreds of biological and advanced therapy medicinal products (ATMPs). Experienced QP with expert medicinal product knowledge gained from over 100 different biological (commercial and investigational) products including ATMPs. Capable of lateral thinking and integrating a wide range of pharmaceutical subjects across advanced technology, science and clinical studies. Understands, from experience, the different requirements of companies of various sizes and stages of development. Uses pragmatic decision-making skills to derive the best solutions to compliantly meet customer and business needs.
Rare Combination of Clinical, Hospital, Academic and Industrial Experience
Highly trained and experienced in research (PhD+), clinical practice (Clinical Hospital Pharmacist) and global industrial manufacture (Industrial Pharmacist EU QP). This allows him to excel at understanding: patient clinical needs, advanced science, applied research and advanced industrial pharmaceutical technology to make reliable patient-centric decisions.
Industrial Pharmacist ATMP Qualified Person (QP)
Pharmacy is the most relevant and aligned degree and profession to perform the role of a QP. Jasbir provides his clients with expert support and advice on the full range of pharmaceutical subjects (medicinal product design, development, clinical trials, commercialisation, manufacture, clinical use). With excellence in both pharma sciences and business/entrepreneurship he supports all phases of product, people and company development.
Team of High Calibre ATMP Translation Consultants
Under the leadership of Dr Jasbir Rattu we have built and continue to build a high calibre team to deliver exceptional development and translation results to our ATMP manufacturing companies.

 

 

VISION, MISSION, VALUES

 

 

Making medicines is more than just my profession or craft. It’s my passion and has become my life’s major purpose and mission.
 
A large part of my inspiration, from early on in my life, is my sister who was born with congenital glaucoma.
 
I have watched her grow to be the greatest and most inspiring person I know; full of compassion, wisdom, understanding, encouragement and an outstanding mother. She has immense vision despite her lack of vision. I couldn’t be more blessed or ask for a better sister and am eternally grateful.
 
I foolishly wasted a at of my youth wrongfully believing that nothing or not much could be done for patients like her. But thankfully my limiting beliefs of what’s possible began to change…

 

ATMPs to cure congenital eye diseases

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.

“Be the change you want to see in the world.”

Mahatma Gandhi

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.

“Where your talents and the needs of the world cross; there lies your vocation.”

Aristotle

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”

Earl Nightingale

Since becoming an experienced Industrial Pharmacist, I am eligible as an EU Qualified Person (QP) in all EU countries (Industrial Pharmacist) and Authorised Person in the rest of the world. I am highly experienced in multiple product type drug development activities in world-class biopharmaceutical companies. I have consulted for many innovative ATMP clients, including internationally in global positions, for major multinationals such as Merck, GSK, Novartis and also in smaller and medium-sized cutting-edge biotech companies, universities, hospitals and charities.

“The only way to do great work is to love what you do.”

Steve Jobs

A Master of Pharmacy degree (MPharm) is my foundation as a multidisciplinary expert on medicines. Its many applications has helped me understand patients’ clinical needs and given me the solid foundation required for thorough, professional, expert knowledge on the design, development, manufacture and clinical use of medicines.

Straight out of University I successfully gained a highly competitive Industry-Hospital pre-registration pharmacist placement (where there were only around 10 places in the whole of the UK between thousands of graduating pharmacist applicants) with a prestigious Pharmaceutical company (Merck) and the world-famous Great Ormond Street Hospital (GOSH), where I started working with advanced therapy investigational medicinal products (ATIMPs).

Subsequently, I gained my PhD in Advanced Therapy Medicinal Product Design from the world-class University of Manchester (which had the highest rating for both research and teaching in the UK).

I consider myself fortunate to be a postdoctoral level scientist and a Healthcare Professional (Pharmacist) who is both scientifically and clinically trained and experienced, having also worked in many NHS and private hospitals.

“Love what you do and do what you love.”

Jasbir Rattu

“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.”

Dr Jasbir Rattu. CeutiQus.

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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