Sartorius Stedim Biotech S.A | August 23, 2021
Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, has entered into a partnership with McMaster University to improve manufacturing processes of antibody and virus-based treatments for diseases such as COVID-19, cancers, and genetic disorders.
Using a state-of-the-art multi-column chromatography system provided by Sartorius Stedim Biotech, the McMaster team will "perfect" a process for the purification of therapeutic viruses that is more effective and cheaper than those currently available. This will pave the way for new and more affordable treatments to reach patients with a variety of needs. "Teaming up with Sartorius Stedim Biotech is an exciting opportunity for McMaster Engineering. This research will push the envelope in leading advanced, cutting-edge research in bio-manufacturing," says John Preston, associate dean, research, innovation and external relations in the Faculty of Engineering. "Establishing industry-friendly, collaborative environments is critical in solving real-world problems."
This work aims to support the Sustainable Development Goals (SDG) set out by the United Nations, designed to give our people and planet a better future. More effective bio-manufacturing can make advanced biotherapeutics cost-effective and available to more people globally. "This partnership with McMaster University will lead to impactful research that will make important treatments available at a greater scale. We see this as a way to expand our research development and bring SDG-aligned pharmaceuticals to Canadian and global markets," says Brandon Corbett, research scientist at Sartorius Stedim Biotech.
David Latulippe, associate professor of Chemical Engineering, and Prashant Mhaskar, professor of Chemical Engineering and Canada Research Chair in Nonlinear and Fault-Tolerant Control, are leading this project with Sartorius Stedim Biotech. The collaboration will initially run for four years.
What is chromatography?
Chromatography is an essential purification technology in biomanufacturing. To produce biotherapeutics, scientists use a bioreactor with specialized cell lines and customized growth media. Next, the biotherapeutic must go through a series of purification steps, often with duplicate steps to satisfy the requirements of regulatory bodies.
Sartorius Stedim Biotechs' multi-column chromatography system uses parallel processing strategies to make the process more resource and cost-efficient. "Our ultimate goal is to perfect the downstream chromatography process by combining detailed experimental work with advanced process modelling concepts," says Latulippe. "This way, we can control the outcome and fix the processes on site, as production is happening, so everything is always 'on spec'." Currently, monoclonal antibodies are the leading biotherapeutic being used to fight against COVID-19.
Training the next generation
As part of the partnership, Sartorius Stedim Biotech will provide student training opportunities at their research and development facilities in North America and Europe. Ian Gough, a graduate of McMaster's Chemical and Bioengineering program, has already started working on this project. Gough is a former member of the Summer Studentship Internship program from BioCanRx, a Networks of Centres of Excellence program. Claire Velikonja, a recent chemical engineering graduate from the University of Toronto, will join the team in September.
Both Gough and Velikonja received a Canada Graduate Scholarship from Natural Sciences and Engineering Research Council of Canada (NSERC) to provide additional support for their first year of graduate studies.
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a total solutions provider, the company helps its customers to manufacture biotech medications safely, rapidly and economically. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In 2020, the company employed more than 7,500 people, and earned sales revenue of 1,910 million euros.
About McMaster University
Ranked among the world's top engineering schools, the Faculty of Engineering plays a significant role in helping McMaster University earn its reputation as one of Canada's most innovative universities. Our focus is on experiential, problem-based learning, and our interdisciplinary approach to collaboration results in smarter insights, groundbreaking ideas, and greater optimism. This approach is helping us create a Brighter World.
Stemcyte | March 23, 2022
On January 7th, 2022, the FDA received the BLA (Biologics License Application) for the "HPC-Cord Blood" product. On March 8th, 2022, StemCyte was formally informed that the submission was acceptable to join the biologics license quality review process.
The "HPC-Cord Blood" is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in patients with hematopoietic system disorders an appropriate preparative regimen for hematopoietic and immunologic reconstitution. There have been over 40,000 successful umbilical cord blood transplants globally to treat disorders of the hematological and immunological systems and genetic metabolic diseases since the first successful use of umbilical cord blood to treat Fanconi Anemia patients in 1988.
StemCyte has donated more than 2,200 cord blood units for transplantation to 1 in every 20 patients with umbilical cord blood transplants globally during the last 20 years. In addition, at least 350 transplant centers around the world, including well-known medical centers such as UCLA Medical Center, Duke University Hospital, Taiwan Chang Gung Memorial Hospital, and National Taiwan University Hospital, consistently meet the quality standards of international accrediting bodies and are recognized and trusted as safe and effective by StemCyte's products.
Berkery, Noyes & Co. | October 08, 2021
Entopsis, Inc., the developer of an unbiased approach to diagnostics using bio-molecular signatures with a focus on oncology, announced that it has engaged Berkery Noyes & Co. as its financial advisor to assist the company in pursuing strategic alternatives for their OpsisDxTM platform.
OpsisDxTM is a urine-based technology platform that shifts the focus away from conventional RNA and DNA approaches, offering a highly sensitive and specific diagnostic test for the detection of early-stage cancers. Its IP-protected platform detects urine chemical signatures via a proprietary array, achieving clinically significant results through its proprietary machine learning algorithms. Validation studies on OpsisDxTM have initially focused on detecting early-stage cancers, and the platform has now expanded to detecting multiple other diseases in a highly scalable fashion.
Now is the time to launch OpsisDxTM. There's greater acceptance of multi-disease testing platforms from a scientific, regulatory and business perspective; the industry as a whole has crossed the tipping point, We are seeking an established partner who shares our vision of empowering people with actionable, low costs and accurate healthcare information with an eye towards the long-term interests of Entopsis.
- Obdulio Piloto, CEO of Entopsis Inc.
Entopsis utilizes a proprietary material science screening platform to develop cost-effective and impactful products.