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.
CELL AND GENE THERAPY
Sartorius | July 05, 2021
Sartorius Stedim Biotech, a leading international biopharmaceutical partner, has acquired a majority stake in CellGenix GmbH, a reagent manufacturer. The company, headquartered in Freiburg, Germany, and with a sales subsidiary near the biotechnology center in Boston, Massachusetts, USA, manufactures and distributes cell culture components in GMP grade for the manufacture of cell and gene therapy products.
Sartorius Stedim Biotech originally purchased 51% of this company, which was previously privately held, for about 100 million euros in cash. Sartorius Stedim Biotech plans to purchase the remaining CellGenix shares in 2023 and 2026. CellGenix, founded in 1994 at the University Medical Center of Freiburg, employs about 70 employees and aims to produce revenues of more than 20 million euros in 2020, with a very high double-digit EBITDA margin.
Sartorius Stedim Biotech intends to significantly expand the Freiburg facility and establish it as a center of excellence within the company to develop and produce high-quality critical raw materials for the cell and gene therapy markets.
This press release includes forward-looking statements regarding the Sartorius Stedim Biotech Group's future development. Forward-looking statements include known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or indicated by such statements. Sartorius Stedim Biotech disclaims all obligation for revising such statements in light of new information or future events. The following is a translation of the original French news release. Sartorius Stedim Biotech accepts no responsibility for the accuracy of this translation. The legally binding version is the original French news release.
Sartorius Stedim Biotech's profile
Sartorius Stedim Biotech is a leading international biopharmaceutical industry partner. As a complete solutions provider, the business helps its clients produce biotech medications in a safe, timely, and cost-effective manner. Sartorius Stedim Biotech, headquartered in Aubagne, France, is listed on the Eurolist of Euronext Paris. Sartorius Stedim Biotech has a worldwide reach thanks to its production and R&D facilities in Europe, North America, Asia, and an international network of sales companies. The Group's yearly growth rate has been in the double digits on average, and it has constantly been extending its portfolio via acquisitions of related technology. In 2020, the business had about 7,500 employees and a sales revenue of 1,910 million euros.
Stramsen Biotech, Inc | December 17, 2020
Stramsen Biotech, Inc, a professional group of medication researchers from the Houston, Texas territory comprises of scientists who devote their lives each day to investigating and exploring both the cycles and logical instruments hidden the world we live in today. Colleagues have gotten a few honors and awards for research ventures, with a significant number of their activities and distributions accessible upon demand. Individuals incorporate PhD and University level professors who specialize in chemistry, medication and different biotechnology research projects. This group of experienced researchers has been included widely in clinical examination for more than 20 years.
Stramsen Biotech, Inc has more than six drug/medicine candidates currently in early-stage clinical trials. Two drug/medicine candidates have demonstrated promising outcomes in early clinical preliminaries for treatment of HIV/AIDS. A third drug applicant has additionally demonstrated promising outcomes in early clinical preliminaries for treatment of numerous kinds of wounds and cuts, including diabetic injuries. A fourth medication applicant shows promising outcomes in early clinical preliminaries for treating the basic Flu and Covid-19. The fifth outstanding medication competitor, focusing on ongoing and advance stage malignant growths, has additionally indicated promising outcomes in early clinical preliminaries. Finally, a 6th applicant as an immunization shows promising clinical preliminary outcomes for Newcastle disease, a infection of domestic poultry and other winged creature species with the virulent Newcastle disease virus (NDV).