Innovating Quality ocular Advanced therapy MediCiNal products 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.

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CeutiQus

CeutiQus offers strategic cutting-edge consultancy in innovative, biological, regenerative and advanced therapy medicinal product (ATMPs), such as:

– Cell therapy
– Gene therapy
– Tissue engineering

Click here for more details of our services.

What is an Advanced Therapy Medicinal Product (ATMP) or Advanced Therapy Investigational Medicinal Product (ATIMP)?

An Advanced Therapy Medicinal Product (ATMP) is a type of medicine used to treat diseases by using advanced technologies that involve manipulating genes, cells or tissues. These therapies 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 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 a licensed medicine with a marketing authorisation 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.

There are four main types of ATMPs or ATIMPs:

1. Gene therapy products: These are medicines that contain genes or genetic material that is designed to correct or replace a defective or missing gene in a patient’s cells.

2. Somatic cell therapy products: These are medicines that involve the use of cells that have been manipulated outside the body and then re-administered to the patient to treat a disease.

3. Tissue-engineered products: These are medicines that are made by combining cells and other biological materials to create functional tissues that can be used to replace or repair damaged tissues in the body.

4. Combination products: These are medicines that contain a combination of the above-mentioned ATMPs, or a combination of an ATMP with a medical device or a medicinal product.

What is an ATMP Qualified Person (QP)?

An ATMP Qualified Person (QP) 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 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 systems are in compliance with Good Manufacturing Practice (GMP) regulations and that any deviations or non-conformities are investigated and resolved.This includes verifying that the manufacturing process has been 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 in the country where the ATMP is being manufactured or marketed.

The biological and Advanced therapy medicinal product (atmp) blog

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HOW WE’RE UNIQUELY QUALIFIED TO HELP YOU

QUALIFICATIONS FOR ATMPS

Jasbir 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.

Industrial Pharmacist 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.

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.

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.

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.

Recognised Expert in Pharmaceutical Biotechnology and ATMPs

Jasbir is a recognised expert in Pharma Biotech 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.

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.

About CeutiQus & ITS LEADER jASBIR

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…

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 (science), 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.

“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 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 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).

Subsequently, I gained my PhD in Medicinal Product (Biopharmaceutical) 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 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!

We look forward to hearing from you.

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