Sartorius Stedim Biotech Closes Acquisition of Slovenian Purification Specialist BIA Separations

Sartorius | November 03, 2020

Sartorius Stedim Biotech (SSB), a leading partner of the biopharma industry, successfully closed the acquisition of the Slovenian purification specialist BIA Separations. The transaction was completed on November 2, 2020, after receiving the required approvals. "BIA's portfolio is highly complementary to Sartorius Stedim Biotech. We are thus creating an excellent offering for the manufacturing of gene therapies and other advanced therapies, and are pleased to welcome 120 new employees," said Dr. Joachim Kreuzburg, Chairman of the Board and CEO of Sartorius Stedim Biotech. The total purchase price of the transaction is 360 million euros of which 240 million euros were paid in cash and 120 million euros in SSB shares. Both parties have further agreed on three tranches of earn-out payments based on performance over the next five financial years. SSB has been preparing to integrate BIA Separations so this can now be initiated despite the special conditions prevailing during the pandemic. BIA Separations develops and manufactures market-leading products for purification and analysis of large biomolecules, such as viruses, plasmids and mRNA, which are used in cell and gene therapies and other advanced therapies. BIA's technology for manufacturing-scale purification is already used in production of the first commercialized advanced therapeutics, and the company also has a strong presence with such novel drug candidates in the clinical pipeline. Expecting continued very strong double-digit sales growth over the next few years, BIA is forecasted to earn sales revenue of approx. 25 million euros in 2020 at profit margins that will be accretive to the underlying EBITDA margin of the Sartorius Stedim Biotech Group. The transaction is not expected to have any material impact on Sartorius Stedim Biotech's 2020 results.

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The future of technology is right around the corner but the big question is - what area will be the next big advancement be? Will robots soon take over human jobs or is the next website destined to bebigger than Facebook on the horizon? It will be interesting to see what the human brain will be capable of creating next. - See more at: http://visual.ly/envisioning-near-future-technology#sthash.qNK2OHUf.dpuf

Spotlight

The future of technology is right around the corner but the big question is - what area will be the next big advancement be? Will robots soon take over human jobs or is the next website destined to bebigger than Facebook on the horizon? It will be interesting to see what the human brain will be capable of creating next. - See more at: http://visual.ly/envisioning-near-future-technology#sthash.qNK2OHUf.dpuf

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CELL AND GENE THERAPY

Childhood Trauma and Genetics Linked to Increased Obesity Risk

DRI | March 10, 2022

New research from the Healthy Nevada Project® found associations between genetics, obesity, and childhood trauma, linking social health determinants, genetics, and disease. The study, which was published this week in Frontiers in Genetics, found that participants with specific genetic traits and who experience childhood traumas are more likely to suffer from adult obesity. In 2016, DRI and Renown Health launched the Healthy Nevada Project®, the nation’s first community-based, population health study, which now has more than 60,000 participants. The project is a collaboration with personal genomics company, Helix, and combines genetic, environmental, social, and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The new study focuses on Adverse Childhood Experiences (ACEs), which are traumatic and unsafe events that children endure by the age of 18. Over 16,000 participants in the Healthy Nevada Project® answered a mental health survey, and more than 65 percent of these individuals self-reported at least one ACE occurrence. These 16,000 participants were cross-referenced with their genetic makeup, and clinical Body Mass Index (BMI) measures. According to the research team’s findings, study participants who had experienced one or more types of ACE were 1.5 times more likely to become obese adults. Participants who experienced four or more ACEs were more than twice as likely to become severely obese. Our analysis showed a steady increase in BMI for each ACE a person experienced, which indicates a very strong and significant association between the number of adverse childhood experiences and adult obesity, More importantly, participants’ BMI reacted even more strongly to the occurrence of ACEs when paired with certain mutations in several genes, one of which is strongly associated with schizophrenia.” lead author Karen Schlauch, Ph.D., of DRI. We know that genetics affect disease in the Healthy Nevada Project®, and now we are recognizing that ACEs also affect disease, Our new study shows that the combination of genes and environmental factors like ACEs, as well as many social determinants of health, can lead to more serious health outcomes than either variable alone. More broadly, this new work emphasizes how important it is for population genetic studies to consider the impact of social determinants on health outcomes.” Healthy Nevada Project® Principal Investigator Joseph Grzymski, Ph.D., of DRI and Renown Health. The study team believes that it is important for clinical caregivers to understand the strong impact that negative childhood experiences such as ACEs can have on both child and adult health. The researchers hope the information from this study will encourage doctors and nurses to conduct simple screenings for ACEs and consider a patient’s social environment and history in combination with genetics when developing treatment plans for better patient health. According to the 2019 Youth Behavior Risk Survey (YRBS), 25.6 percent of Washoe County teenagers are overweight or obese. Obesity is a serious health concern for children and adolescents. According to the Centers for Disease Control and Prevention, obese children and adolescents are more likely to become obese as adults. Obese and overweight children and adolescents are at risk for multiple health problems during their youth, which are likely to be more severe as adults, Obese and overweight youth are more likely to have risk factors associated with cardiovascular diseases, such as high blood pressure, high cholesterol, and type 2 diabetes. Losing weight, in addition to a healthy diet, helps to prevent and control multiple chronic diseases and improves quality of life for a lifetime.” Max J. Coppes, MD, PhD, MBA, FAAP, Nell J Redfield Chair of Pediatrics at the University of Nevada Reno School of Medicine, Physician in Chief of Renown Children's Hospital. We’d like to thank all of the Healthy Nevada Project® participants who provided information to make our work possible, Our research illustrates that it’s not just genetics that cause disease, but that our environment and life experiences interact with our genes to impact our health in ways that we are only beginning to understand.” Robert Read, M.S., of DRI. About DRI The Desert Research Institute (DRI) is a recognized world leader in basic and applied environmental research. Committed to scientific excellence and integrity, DRI faculty, students who work alongside them, and staff have developed scientific knowledge and innovative technologies in research projects around the globe. Since 1959, DRI’s research has advanced scientific knowledge on topics ranging from humans’ impact on the environment to the environment’s impact on humans. DRI’s impactful science and inspiring solutions support Nevada’s diverse economy, provide science-based educational opportunities, and inform policymakers, business leaders, and community members. With campuses in Las Vegas and Reno, DRI serves as the non-profit research arm of the Nevada System of Higher Education.

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MEDTECH

CosmosID Launches Accurate and Easy Functional Microbiome Analysis with New Software Platform, CosmosID-HUB: Microbiome

CosmosID | September 27, 2021

A complete analysis of the microbiome should combine taxonomic profiling ("who is there?") with functional characterization ("what are they doing?") to discover the capabilities of an entire community of microorganisms. But research teams often require specialized training and extensive computational infrastructure to establish an in-house suite of tools for processing shotgun metagenomic data – and even with the right know-how, the processing can be both time-consuming and challenging. CosmosID®, known for the most accurate, multi-kingdom, strain level taxonomic profiling technology, has added a functional analysis module to its popular online user-interface, renamed 'CosmosID-HUB: Microbiome'. Now, in addition to microbiome sequencing services out of its Germantown, MD, laboratory, its industry-leading team of bioinformaticians and software developers, has unveiled a suite of new features for seamless analysis of the genomic potential of microbial communities: Direct links from the platform to MetaCyc and GO terms databases. Data import via direct upload, Illumina BaseSpace & automated SRA import from NCBI with analysis speeds up to 19X faster than open-source tools. Find your organism or gene/pathway of interest with search functions, exportable charts & visualizations. Comparative analysis software, complete with dynamic charts, graphs, and statistical significance testing. Easy-to-navigate user interface OR command-line access. Applicable to almost any sample type Applicable to both metagenomic and metatranscriptomics data Knowing the combined genomic potential of a microbial community is proving indispensable for practical applications of translational microbiome science, This cutting edge, accurate, easy and fast functional analysis feature is part of our ongoing mission to provide everything researchers need to complete their end-to-end microbiome analysis and lower the barrier to entry for those interested in the field. - CosmosID CEO, Manoj Dadlani. The updated web application is part of CosmosID's microbial genomics platform, CosmosID-HUB, which is continually expanding with various apps and modules for analyzing microbial communities and for inferring translational and actionable microbiome insights. Currently, CosmosID-HUB: Microbiome provides options for discovering antimicrobial resistance and virulence markers, microbial taxa (composition) and function whereas CosmosID-HUB: COVID-19 is a separate module for detecting the presence of COVID-19 and characterizing variants of concern/interest in both clinical and wastewater specimens. Researchers have the flexibility to access and pay for the type of analysis they require. Soon, CosmosID-HUB will include a revolutionary web application for microbiome multi-dimensional feature testing and multi-omics analysis. In addition to strain-level resolution enabled by its curated databases of over 170,000 genomes and gene sequences, CosmosID® also offers next-generation sequencing services. To date, the company has demonstrated its best-in-class technology and won three different challenges for its detection accuracy, including both PrecisionFDA challenges as well as the Janssen/DNAnexus Mosaic 'Strain' challenge. About CosmosID® CosmosID® provides end-to-end solutions unlocking the microbiome. A provider of CLIA-certified & ICH-GCP compliant NGS Services and Bioinformatics Solutions, CosmosID offers a range of validated and optimized workflows for a range of applications including pharmaceutical R&D, infectious disease diagnostics, environmental testing, microbiome research, animal health, cosmetics & personal care as well as many more. CosmosID also offers independently validated, industry-leading pipelines for processing metagenomic data, yielding multi-kingdom, strain-level resolution with leading sensitivity and precision as well as functional characterization

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INDUSTRIAL IMPACT

Sutro Biopharma and Tasly Biopharmaceuticals Enter into Exclusive License Agreement for STRO-002 in Greater China

Sutro Biopharma | December 28, 2021

Sutro Biopharma, Inc. a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, announced an exclusive license agreement with Tasly Biopharmaceuticals Co., Ltd. a holding subsidiary of Tasly Pharmaceutical Group Co., Ltd. for the development and commercialization of STRO-002 in Greater China, consisting of mainland China, Hong Kong, Macau and Taiwan. STRO-002 is a FolRα-targeting antibody-drug conjugate, currently in clinical studies for patients with ovarian and endometrial cancers in the U.S. and Europe. Under the terms of the agreement, Sutro will receive an upfront payment of $40 million and be eligible to receive potentially up to $345 million in development and commercial milestone payments. Tasly will pursue the clinical development, regulatory approval, and commercialization of STRO-002 in Greater China for ovarian and endometrial cancers, with the potential to expand to further oncological indications including non-small cell lung cancer and triple-negative breast cancer. Sutro retains development and commercial rights of STRO-002 outside of Greater China. Sutro will be responsible for the clinical trial and initial commercial supply of STRO-002 for trials in the licensed territory pursuant to a supply agreement according to customary terms. Upon commercialization, Sutro will receive tiered, double-digit royalties based on annual net sales of STRO-002 in Greater China. "We are delighted to gain access to this promising drug, which has the potential to be the best-in-class FolRα ADC for patients with debilitating cancers, including ovarian cancer and potentially FolRα-expressing cancers. There is a huge unmet need for oncology patients within Greater China and we look towards future development and commercialization of STRO-002 to serve these needs." Kaijing Yan, Chairman of the Board Bill Newell, Chief Executive Officer of Sutro added, "This agreement further validates our emerging clinical data surrounding the development of STRO-002. Tasly is an excellent partner for our Greater China collaboration, with a history of successful execution for developing and commercializing therapeutics. We are delighted to broaden the geographical footprint of STRO–002 and allow greater access for cancer patients to a new possible treatment option." About Tasly Biopharmaceuticals Tasly Biopharmaceuticals was founded in 2001 and has more than 20 years of experience in the independent research and development and commercialization of biopharmaceutical products. As a leading innovative biopharmaceutical company in China, Tasly Biopharmaceuticals has a commercialization platform integrating research and development, manufacturing and sales. The company is one of the few pharmaceutical companies in China that can apply perfusion cell culture technology to long-term large-scale commercial production; the company has successfully developed and commercialized its flagship biologic product, Pro-UK, which has great potential to become a blockbuster thrombolytic drug in China. The company focuses on the development of biopharmaceutical products in the three therapeutic areas including cardio-cerebrovascular, oncology & autoimmune, and alimentary tract & metabolism, and it currently has 16 biopharmaceutical pipeline products. The company aims to bring affordable and first-in-class/best-in-class biologic drugs to Chinese patients to meet the growing and unmet clinical needs in the targeted therapeutic areas. About Sutro Biopharma Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.

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