Innovating Quality Ocular Advanced Therapy Medicinal Products (ATMPs) Intelligently

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21 insights into biological & advanced therapy medicinal products (ATMPs)

Insight [in-sahyt], noun.

(The ability to have) a clear, deep, and sometimes sudden understanding of a complicated problem or situation.

See deeper into biological and advanced therapy medicinal products (ATMPs) at just a glance with this free, easy to read, downloadable booklet.

ATMP Consulting

CeutiQus offers cutting-edge 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 and quality guidance.

Patient being treated with ATMP in hospital bed

 

There are four main types of ATMPs or ATIMPs:

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).

Gene therapy products

A gene therapy medicinal product (GTMP) is a biological medicine that both:

 – contains a recombinant nucleic acid as its active substance, used to regulate, repair, replace, add, or delete a genetic sequence in the body. 

– has a therapeutic, prophylactic, or diagnostic effect directly related to the nucleic acid sequence it contains, or to the product of the genetic expression of this sequence.

GTMPs are hence medicines that contain genes or genetic material that is designed to correct or replace a defective or missing gene in a patient’s cells. 

NB. GTMPs do not include vaccines against infectious diseases.

 

Examples of gene therapy medicinal product (GTMPs)

Some examples of gene therapy medicinal product (GTMPs) include a medicine that uses a recombinant nucleic acid to:

– repair a genetic mutation that causes cystic fibrosis.
 
– add a gene that produces a protein that helps to fight cancer.
 
– delete a gene that causes a rare blood disorder. 

Gene therapy medicinal products may be further categorised as either in vivo or ex vivo.

In vivo gene therapy

In vivo gene therapy is a type of gene therapy where genetic material is delivered directly to cells in the body.

Example of an in vivo gene therapy medicinal product

One example of an in vivo gene therapy is Luxturna (voretigene neparvovec-rzyl). Luxturna is an AAV-based gene therapy product that is used to treat inherited retinal dystrophy (IRD), a group of genetic diseases that cause blindness. Luxturna works by replacing a mutated gene (RPE65) that is responsible for the production of a protein that is essential for vision.

 

Ex vivo gene therapy

Ex vivo gene therapy is a type of gene therapy where cells are removed from a patient’s body, genetically modified, and then returned to the patient’s body. 

Example of an ex vivo gene therapy medicinal product

An example of ex vivo gene therapy is the genetic modification of CD34+ haematopoietic stem cells (HSCs) with the Adenosine deaminase (ADA) gene to treat ADA-SCID. CD34+ HSCs are a type of stem cell that can give rise to all types of blood cells. The ADA gene is responsible for the production of an enzyme that helps to break down toxins in the body. These toxic substances can damage the DNA of T cells and B cells, which prevents them from developing properly. As people with ADA deficiency are unable to produce this enzyme, this can lead to a number of serious health problems, including severe combined immunodeficiency (SCID). In ex vivo gene therapy for ADA deficiency, CD34+ HSCs are removed from a patient’s body and genetically modified to produce the ADA enzyme. The modified cells are then returned to the patient’s body, where they can produce the enzyme in the immune system cells and help to correct the deficiency. Ex vivo gene therapy has been shown to be an effective treatment for ADA deficiency. In clinical trials, this ex vivo gene therapy has been shown to be able to cure ADA deficiency in about 90% of patients.

Gene therapy products

Somatic cell therapy products

Somatic cell therapy medicinal products are biological products that contain cells or tissues that have been manipulated to change their biological characteristics, or cells or tissues that are not intended to be used for the same essential functions in the body.

These products are used to treat, prevent, or diagnose diseases through the pharmacological, immunological, or metabolic action of their cells or tissues.

Examples of somatic cell therapy products

Examples include cells of the immune system e.g. T cells, B cells, dendritic cells, natural killer cells, macrophages etc.

Other examples include stem cells which are undifferentiated cells that have the potential to develop into a variety of different cell types.

Stem cell technology morula

Tissue-engineered products

Tissue-engineered products (TEPs) are medicines that contain “engineered” cells or tissues used to regenerate, repair, or replace human tissues.

Examples of TEPs include artificial skin for burns, cartilage implants for arthritis, tissue-engineered bladders for bladder diseases and bone implants for bone fractures and injuries.

Tissue-engineered products can contain cells or tissues from humans or animals, and they can be viable or non-viable. They may also contain other substances, such as cellular products, biomolecules, biomaterials, chemical substances, scaffolds, or matrices.

NB. Products that contain only non-viable cells and/or tissues are not considered tissue-engineered products.

Cells or tissues are considered “engineered” if they have been changed in a way that makes them better able to regenerate, repair, or replace human tissues.

The changes must be significant enough to improve the cells or tissues’ biological characteristics, physiological functions, or structural properties.

Some changes, such as those listed in Annex I to Regulation (EC) No. 1394/2007 (the Advanced Therapy Medicinal Products (ATMPs) Regulation), are not considered to be significant enough to make the cells or tissues “engineered.”

Cells or tissues are also considered “engineered” if they are not intended to be used for the same essential function or functions in the recipient as in the donor.

Examples of tissue-engineered products (TEPs)

Some examples of engineered cells or tissues include:

– Skin cells that have been genetically modified to be resistant to scarring.

– Heart muscle cells that have been grown in a lab and then transplanted into a patient.

– Cartilage cells that have been harvested from a patient’s knee and then cultured in a lab to repair a damaged joint.

They are a relatively new type of medicine, and they are still under development but have the potential to revolutionise the way we treat diseases and injuries. They could be used to replace damaged or diseased tissues of the human body. Tissue-engineered products could also be used to grow new organs (organ regeneration), such as kidneys and livers. They are a promising new area of medicine, and they have the potential to improve the lives of billions of people.

tissue engineering and regenerative medicine

Combination ATMP products

A combined advanced therapy medicinal product (cATMP) is an advanced therapy medicinal product (ATMP) that contains one or more medical devices.

To be classed as a combined ATMP product the cATMP must meet the following conditions:

– The medical device must be an integral part of the product

– The cellular or tissue part of the product must contain viable cells or tissues.

– The cellular or tissue part of the product containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to.

Combination ATMP products (cATMPs)

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 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, 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 is a highly experienced ATMP Qualified Person (QP)

 

 

Dr Jasbir Rattu Biologics and ATMP Expert 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 ATMPS

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 20 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 idea to product 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 20 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.

 

This is the clear vision of CeutiQus.

 

We value vision, clarity, growth and contribution.

 

For further information on our services, be it consulting, coaching, training, speaking, please get in touch below.

 

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