MEDICAL

AlgaEnergy Agreements with Laboratoire M2 for Distribution and Product Development

AlgaEnergy | January 14, 2021

AlgaEnergy N.A. Inc., the U.S. subsidiary of Spain-based AlgaEnergy S.A. furthermore, a worldwide pioneer in microalgae biotechnology, has marked worldwide item conveyance and item improvement concurrences with Laboratoire M2 Inc., a Quebec-based biotechnology organization that creates normal and practical disinfectant items, including THYMOX CONTROL® fungicide and bactericide.

AlgaEnergy formulates and creates incredible, manageable, microalgae-based yield contributions for the world's producers. Laboratoire M2's THYMOX® items, gotten from the antimicrobial intensity of thyme oil and other regular oils, are utilized in harvest and indoor farming, just as in turf and nursery markets.

Under the arrangements, AlgaEnergy will acquire restrictive worldwide rights to disperse the THYMOX crop insurance product offering through AlgaEnergy's specialty units in key rural business sectors in Europe, the Americas, Africa and Asia-Pacific. The two organizations likewise marked a permit and collective item advancement understanding under which their logical groups will together attempt to make new, value-added biocontrol products.

Spotlight

The biotechnology industry has experienced accelerated growth in recent years. The major factor influencing this growth has been large pharmaceutical companies looking for their next blockbuster drug coupled with an aging population facing a long list of chronic diseases.

Spotlight

The biotechnology industry has experienced accelerated growth in recent years. The major factor influencing this growth has been large pharmaceutical companies looking for their next blockbuster drug coupled with an aging population facing a long list of chronic diseases.

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INDUSTRIAL IMPACT

Enteris BioPharma Completes Manufacturing Facility Expansion and Announces the Launch of CDMO Business Segment

Enteris BioPharma | May 04, 2021

Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies and a wholly-owned subsidiary of SWK Holdings Corporation, announced today the expansion of its Boonton, NJ manufacturing facility and the launch of its CDMO business segment, which provides custom solutions for the formulation, growth, and manufacturing of pharmaceuticals. Enteris also offers bench to market facilities, such as the development, manufacturing, monitoring, and release of Phase 1 to Phase 3 clinical trial supplies, as well as commercial products. The 32,000-square-foot expanded facility includes 6,000 square feet of cleanroom space, with approximately 2,500 square feet devoted to the containment and processing of high potency API (HPAPI). "This is a huge achievement for Enteris and will play an important role in our future growth plans," said Rajiv Khosla, Ph.D., Chief Executive Officer of Enteris. "Our purpose-built manufacturing facility will now manufacture CTM up to Phase 3, as well as product for commercial launch. These enhanced capabilities place Enteris to take advantage of a range of growth opportunities, and we plan to fully utilize this opportunity. Enteris will now seek deeper development and manufacturing collaborations with partners by offering custom solutions from bench to market." The HPAPI containment area at the manufacturing plant is planned to safely accommodate highly potent APIs. Depending on the physical properties of the solid oral dosage unit, batch sizes can range from a few hundred to hundreds of thousands of dosage units. The facility also features 1,700 square feet of flexible suite space that can be customized to meet the development and manufacturing needs of a partner. "Delivering on a construction timetable during the COVD-19 pandemic was no easy task, and the Enteris team is to be applauded for fulfilling the challenge," said Paul Shields, Ph.D., Enteris' Chief Operating Officer. "We look forward to using the enhanced manufacturing capabilities to deepen existing manufacturing relationships and strengthen our ability to secure new high-value relationships with companies seeking CDMO capabilities in the United States, regardless of whether the product is a solid oral formulation using our proprietary oral formulation technologies, Peptelligence® or ProPermaTM, or other tablet technology." About Enteris BioPharma Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation that provides complete integrated contract development and manufacturing (CDMO) services, including creative formulation methods that use its patented drug delivery technologies, Peptelligence® and ProPermaTM. Numerous feasibility trials and successful research projects have been conducted on the technologies, with many of them now in late-stage clinical development. Furthermore, Enteris BioPharma is developing an internal product pipeline of oral tablet reformulations of drug products that target significant treatment opportunities that do not have an oral delivery option.Ovarest® (oral leuprolide tablet), Enteris BioPharma's most advanced internal product candidate, is an oral peptide being developed for the treatment of endocrine disorders. Enteris BioPharma is also developing TobrateTM (oral tobramycin tablet) for the treatment of uncomplicated urinary tract infection (uUTI).

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MEDICAL

Nordic Bioscience and Roche Diagnostics Strengthen Collaboration for Development of Biomarkers for Chronic Diseases

Nordic Bioscience | June 17, 2022

Nordic Bioscience, a growing biomarker company, today announced the strengthening of its ongoing collaboration with Roche Diagnostics for the development of proprietary biomarkers involved in tissue breakdown and build-up. Nordic Bioscience is a world leader in Extra Cellular Matrix (ECM) biomarker development that can provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting. Under the collaboration, Nordic Bioscience will transfer unique and proprietary blood-based biomarkers to Roche Diagnostics to be implemented on the automated COBAS platform. Nordic Bioscience's ECM biomarkers are unique and essential for all chronic diseases involving tissue fibrosis and inflammation. The collaboration will facilitate better clinical decisions in drug development and patient selection as well as enrichment for precision medicine and ultimately improve patient outcomes. Nordic Biosciences has a long and successful collaboration with Roche Diagnostics. To date, two biomarkers have been commercialized and implemented on the Roche automated COBAS platform. Nordic Bioscience's fibrogenesis biomarker PRO-C3 has become a commonly used next-generation and noninvasive biomarker to quantify type III collagen formation which is highly relevant for NASH and other fibrotic diseases. PRO-C6 quantifies type VI collagen formation, which is highly relevant for cardiovascular diseases and various cancer types. The FDA recently published a letter of support for further studies of PRO-C6 as a trial enrichment and patient selection biomarker in relation to Heart Failure with Preserved Ejection Fraction (HFpEF). PRO-C3 and PRO-C6 are part of Nordic Bioscience's portfolio of ECM biomarkers which are being developed and commercialized both as research tools and in the future as diagnostic products. Both biomarkers have completed the technical development from manual ELISA to automated version on the COBAS platform. They are validated and currently running in routine in the CAP-accredited laboratory of Nordic Bioscience. The collaboration with Roche Diagnostics is an important step for Nordic Bioscience in our efforts to help accelerate drug development. Having our biomarkers on the Roche Diagnostics' platform and our combined capabilities will secure global availability of our best ECM biomarkers. This also adds significant value to Nordic Bioscience offerings as we transform our biomarkers from tools used only in clinical development to globally available diagnostics products." Morten Karsdal Chief Executive Officer of Nordic Bioscience. Nordic Bioscience has a long track record of research in ECM remodeling, which previously has resulted in the transfer of the FDA-approved bone biomarker CTX-I to the Roche COBAS platform. Nordic Bioscience has developed more than 125 ELISA biomarkers focusing on quantifying unique fragments of the ECM. These tools are used in all phases of drug development and for patient selection in various diseases. About Nordic Bioscience Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. Nordic Bioscience is engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting.

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CELL AND GENE THERAPY

Sartorius Stedim Biotech Strengthens its Product Portfolio for Cell and Gene Therapies by Acquiring a Majority Stake in CellGenix

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.

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