Cell and Gene Therapy, Diagnostics
Globenewswire | July 04, 2023
NorthX Biologics (‘NorthX’), a leading Nordic development and manufacturing organisation with a focus on advanced biologics, CGT (cell and gene therapy) and vaccines, announced today the successful acquisition of the Stockholm-based Clinical Trial Manufacturing unit from Valneva Sweden, significantly expanding capabilities.
The acquisition includes the transfer of a multi-purpose facility, situated in the Stockholm life science cluster, close to Karolinska University Hospital. In addition, 30 staff members who currently operate the facility will also join NorthX. The site and staff have a long history with extensive experience of serving both Valneva internally and also working with external customers on a contract development and manufacturing basis. With expertise in mammalian expression systems and viral vectors, the capabilities complement those of NorthX’s existing business of advanced microbial based manufacturing of proteins and plasmid DNA. The acquired unit excels in process development, scale up, GMP production, quality control analytics, and quality assurance/release and is capable of working with Biosafety Level (BSL) 2/2+ and BSL 3 organisms. With this expansion, NorthX enhances its capabilities and can offer comprehensive services to a wider range of clients globally.
Janet Hoogstraate, currently Managing Director of Valneva Sweden, will join the NorthX team. She commented, “I am very proud when looking back at what we have achieved within the unit over the past years and look forward with great enthusiasm to build on NorthX’s position as the go-to manufacturer of advanced biologics in Northern Europe.”
Helena Strigård, CEO of NorthX, said, “We are delighted to join forces with our new colleagues in Stockholm to bring new innovative treatments to tomorrow’s patients.”
Thomas Eldered, Chairman of NorthX, commented, “This strategic move marks a significant milestone in our growth journey and strengthens NorthX as Sweden’s Innovation Hub. We are now able to work with ATMPs and advanced biologics, including process development and manufacture for clinical trials and commercial requirements.”
ABOUT NORTHX BIOLOGICS
NorthX Biologics develops and manufactures advanced biologics and has over 30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cell therapy and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide. In 2021 NorthX was recognised and appointed as the national innovation hub for GMP manufacture of advanced therapeutics and vaccines by the Swedish Government and Vinnova, Sweden's innovation agency. NorthX has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies. For more information visit www.nxbio.com.
Medical, Industry Outlook
PRNewswire | July 19, 2023
BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, announced today that it has acquired PrecisionMed, LLC, a leading supplier of high-quality human biological material for genetics, drug discovery, and biomarker research and in vitro diagnostics.
Based in Carlsbad, CA, PrecisionMed has been collecting biospecimens for neurology and oncology research for more than 27 years, and it has the largest private, global repository of longitudinally collected human CSF for scientific research. Its collection contains both normal and diseased CSF samples together with other matched biofluids, such as plasma, sera, and whole blood.
"We are thrilled to announce BioIVT's acquisition of PrecisionMed. Our vision is to lead the biospecimen industry through expertise and innovation and our acquisition of PrecisionMed pushes us even closer to this goal. We are excited about the possibilities that lie ahead as we expand our supply network and inventory and strengthen our capacity to meet the increasing customer demand for CSF and liquid biopsy products. Together, we will drive even greater value for our customers and further our mission of enabling smarter science," said BioIVT Chief Executive Officer Richard Haigh, PhD.
"The vision at PrecisionMed has always been centered around positively impacting patients' lives through fueling innovation and scientific discovery. We have long viewed BioIVT as the gold standard in our industry with the track record and global reach to back that up. This partnership magnifies our collective ability to reach the research community and impact patient lives. We are proud to pair our talent and resources with the world-class team at BioIVT," said PrecisionMed CEO Eric Leach.
PrecisionMed's regulatory-compliant and privacy-protected biorepository contains more than 170,000 samples of CSF, whole blood, serum, plasma, PBMCs, and urine collected under Institutional Review Board-approved clinical protocols. This extensive collection of high-quality, well annotated biospecimens was amassed from PrecisionMed's sizable network of donors and collection sites. Each biospecimen includes detailed clinical data, such as the donor's diagnosis, demographics, family medical histories, treatment responses, and disease progression.
Underscoring the value of its contributions, PrecisionMed has received more than 120 citations in scientific journals and its collections have been part of U.S. NIH grants and have formed the basis of U.S. FDA submissions and subsequent U.S. FDA clearance for diagnostics.
Looking ahead, PrecisionMed will continue to operate out of its current headquarters and maintain its existing network of donor and collection sites. Financial details about this transaction were not disclosed.
About PrecisionMed, LLC.
PrecisionMed is a leading supplier of high-quality human biological material for research, and it is the largest private global source of longitudinally collected human cerebrospinal fluid (CSF) from living normal controls and diseased populations. Since 1996, its accurately annotated human biological samples have been utilized by more than 600 pharmaceutical and biotechnology companies, and academic research organizations worldwide.
BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. Recognized as an industry leader, BioIVT specializes in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. By combining technical expertise and exceptional customer service with unmatched access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®.
Medical, Industry Outlook
PRNewswire | July 12, 2023
Anbio, a leading provider of innovative diagnostic solutions, proudly presents the Anbio ADL i1910, a fully automated, compact, and affordable CLIA analyzer designed to transform the landscape of clinical diagnostics. With its cutting-edge technology and versatile capabilities, the ADL i1910 offers a comprehensive range of qualitative and quantitative testing options for analytes in human serum, plasma, whole blood, and urine samples.
The ADL i1910 utilizes a direct chemiluminescence method based on acridinium ester, ensuring accurate and reliable results across a wide array of applications. Whether it's hormone detection, myocardial disease screening, infectious disease diagnostics, or tumor-related antigen analysis, the ADL i1910 delivers exceptional performance and meets the diverse needs of modern healthcare professionals.
Key Features of the Anbio ADL i1910
Extensive Assay Menu: The ADL i1910 boasts an impressive range of 49 developed assays, allowing for both qualitative and quantitative testing of analytes. This comprehensive immunodiagnostic solution enables healthcare providers to access critical information efficiently.
High Throughput: With a remarkable throughput of up to 120 tests per hour, the ADL i1910 significantly enhances laboratory productivity. Rapid turnaround times enable healthcare providers to make timely and informed decisions, ultimately improving patient care.
Compact Footprint: Anbio understands the importance of laboratory space. The ADL i1910 has been meticulously designed to occupy minimal space, making it suitable for laboratories of all sizes. Its small footprint ensures that valuable space can be optimized for other essential equipment.
User-Friendly Interface: The ADL i1910 features an intuitive graphic user interface with a large color touch screen, simplifying operation and minimizing the learning curve. The user-friendly design ensures ease of use for both experienced professionals and new users, enhancing overall efficiency.
"Anbio is proud to introduce the ADL i1910, a breakthrough CLIA analyzer that revolutionizes clinical diagnostics," said Jack Davis, Chief Business Officer at Anbio. "With its advanced technology, extensive assay menu, and impressive throughput, the ADL i1910 provides healthcare professionals with a reliable and efficient solution for a wide range of diagnostic applications."
The Anbio ADL i1910 is set to transform the field of clinical diagnostics, empowering healthcare providers with a cost-effective and comprehensive solution.
About Anbio Biotechnology
Anbio Biotechnology is devoted to making contributions for human health and has never stopped our goal to innovate in life sciences. Driven by continuous technical development and integration, resulting from close cooperation with prestigious institutes across the world. Anbio always strives to provide total solutions in clinical diagnosis field, by offering extensive diagnostic products including laboratory and point-of-care products.