Founded on the vision of ethically and scientifically exploring the full potential of stem cells for transforming medicine and offering new hope to millions of people, Stempeutics Research Pvt. Ltd. is striving ceaselessly on its path towards developing innovative stem cell products that address prominent unmet medical needs with an ‘India first, global next’ approach.
Stempeutics, founded by the Manipal Group in 2006, is a late-stage life science company focused on developing and commercializing novel therapeutics based on adult stem cells. Stempeutics’ strength lies in developing innovative stem cell-based products by nurturing cutting-edge research and clinical applications through the dedicated efforts of its highly qualified team. Scientists working at Stempeutics have filed over 65 patents and have published over 75 peer-reviewed international publications.
The company’s flagship product, Stempeucel® drug, is an on-demand, off-the-shelf product based on pooled, allogeneic Mesenchymal Stromal Cells (MSC) derived from the bone marrow of healthy, adult volunteers.
Research conducted at Stempeutics has shown that pooling technology balances out variations observed with individual donor cells, resulting in a product with strong immune-modulatory properties, broader cytokine/growth factors array, longer lifespan, and consistent clinical outcomes.
Stempeucel® is being developed for the treatment of Critical Limb Ischemia (CLI), Osteoarthritis (OA), Diabetic Foot Ulcer (DFU), Perianal Fistula (PAF), and Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 pneumonia.
In August 2020, the Drug Controller General of India (DCGI) granted the manufacturing and marketing approval of Stempeucel® product for the treatment of CLI. Stempeucel® thus became the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI indication.
Stempeucel® has been licensed to Cipla for CLI & DFU indication and to Alkem Labs for OA indication for the India territory. Stempeucel® has strong patent protection with 18 patent applications filed across the globe out of which 16 have been granted.
The core Stempeucel® patent has been granted in the USA, Australia, New Zealand, South Africa, Japan, China, Singapore, UK, France, Germany, Italy, and the Philippines. Stempeucel® has been classified as an ATMP product by EMA and designated as an Orphan Drug for the treatment of CLI due to Buerger’s Disease.
Stempeutics’ proprietary pooling approach provides for an efficient manufacturing process thereby enabling the products to be made accessible to patients at an affordable cost. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent products to patients. The proprietary technology also helps Stempeucel® extend the therapeutic potential of the drug across multiple disease categories.
In Critical Limb Ischemia, Stempeucel® directly addresses the root cause of the disease by reducing inflammation, stimulating the growth of collateral blood vessels, and repairing damaged muscle, thereby reducing the pain, healing the ulcers, and salvaging the affected limb.
“Our company strongly believes in ‘Science Driving the Business’. While there are many companies around the world focusing on ‘Mesenchymal Stromal Cells’, the stem-cell technology platform what we have adopted is unique and novel for the development of treatment for immune-mediated and inflammatory diseases,” says Mr. BN Manohar – the MD and CEO of Stempeutics Research.
Mr. Manohar has transformed Stempeutics – a life science start-up from R&D to commercialization stage with Global recognition. Under Manohar’s leadership, Stempeutics has been recognized as India’s hottest startup by Business Today in 2008 and Karnataka Government bestowed the “Emerging Company of the Year Award” in 2011 and 2013.
In 2017 Manohar was awarded the “Biotechnologist of the Year” award by the Wockhardt Foundation, India. He raised US$ 10M in 2009 by establishing a strategic alliance with Cipla and US$ 13M in 2019 by establishing a strategic alliance with Kemwell Biopharma.
Stempeutics Research believes that India is already seen as the world’s low-cost pharmacy as far as conventional therapies are concerned, and the recent economic and epidemiological changes present a lucrative opportunity for the Indian biotechnology industry to replicate this success in the field of novel and innovative healthcare therapies that include biopharmaceuticals, vaccines, and regenerative medicine, etc.
“In 2021 Union Budget, Kiran Mazumdar-Shaw is seeking measures that can help India transition from being a volume player to being a substantial value player in the global market. She has also sought ways to incentivize investments for start-ups and to support risk capital,” comments Mr. Manohar.
To catch up to these significant opportunities, Stempeutics’ growth objectives for the next few years include:
- Revenue generation in India and Exports: Commercialization of Stempeucel® cell therapy product for three key indications – Critical Limb Ischemia in 2021, Knee Osteoarthritis in 2021, and non-healing Diabetic Foot Ulcer in 2022
- Expansion to other countries where Indian regulatory approval is accepted.
- Globalizing Stempeucel® product for a select indication. Cross key regulatory milestones in Japan (PMDA), EU (EMA) & US (FDA) for commercializing Stempeucel® product for the select indication.
- Scaling Commercial manufacturing with 3D technology and make the product affordable in India.
Source: https://insightscare.com/stempeutics-research-an-leading-name-in-stem-cell-therapeutics/
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Healthcare facilities and services in India have been evolving with time and in recent years have been on a path of continuous development.Companies across this spectrum are ceaselessly striving to deliver the best of their potential in order to cater to the ever-increasing demands of the healthcare industry.
This edition, Best of 5 Regenerative Medicine Companies, places a spotlight on those companies that are bringing about profound changes and innovations in the sphere of regenerative medicine.One prominent name among these companies is Advancells, an India-based research-oriented company focused on regenerative medicine and its therapeutic applications.In the following interview with Insights Care, Vipul Jain, the CEO and Founder of Advancells Group shares with us in detail about the current landscape of the healthcare sector and how his company has gained a strong foothold within the same.Below are the highlights of the interview:Brief our readers about Advancells, its vision, and the key aspects of its strong position in the healthcare industry.Advancells Group is a multifaceted organization that focuses on cell culture research and stem cell therapeutics to encourage academic and industrial innovations in the healthcare domain.
An offshoot of the same, Advancells strongly believes that stem cell therapy and regenerative medicine can change the global viewpoint of medical healthcare in the years to come.Humankind is looking towards an era where personalized medicine will replace drugs, organ transplantation will be based on 3D printed organs, and aging will be a reversible process.
Advancells bridges this gap by creating regenerative therapy awareness and encouraging stem cell therapies.When it comes to our USPs, Advancells harbors cGMP certified cell culture laboratories and expert research personnel to ensure that our clients get the best quality of stem cells for therapy and research, besides other bioproducts like tissue-specific and disease-specific primary cells.When it comes to patient treatment and policies, with a gross 70% therapeutic success rate, many patients have found significant relief from disorders of osteoarthritis, diabetes, and ALS with stem cell therapy.The credit of Advancells being a preferred choice for stem cell therapy goes to our medical experts who play a major role in helping doctors, patients and caregivers in understanding the clinical potential of stem cell therapy.
Besides spending resources and time on vaccines and alternative therapies, many big firms have pushed a lot of effort into drug designing and repurposing.
And how are you strategizing your company’s operations for that future?As far as the healthcare industry is concerned, it is inevitable that the post-COVID-19 period is going to see a boom in business.Regarding the operations of Advancells, we have always been a step ahead in organizing and strategizing the market demands to maintain an optimum balance between business profits and social welfare through healthcare, even in times of a crisis.
The industries of medicine in Pakistan have grown by leaps and bounds and there is no dearth of scope and opportunity for the right kind of manpower.
These industries are creating new job opportunities for youth as well as senior citizens.
These professionals can work as production engineers, quality controllers, quality managers, quality assurance officers, technical translators, quality analysts, project managers, product development staff, and pharmaceutical marketing staff.Top Pharmaceutical Companies in Pakistan are focusing more on the development of new technologies for the production of effective medicines that can tackle the deadliest and life-threatening diseases that have made the headlines globally.
Professionals who are able to manage R, marketing, and business operations for international Pakistani pharmaceutical companies are needed.
They provide jobs and healthy food for millions and provide livelihoods for rural people.
A large number of people depend on these industries for their livelihood as well as their health.Pakistan is emerging as a hub for the manufacturing of medicines with global quality standards and stringent guidelines.
