Medical
businesswire | October 19, 2023
Global genomics solutions provider Integrated DNA Technologies (IDT), an operating company in the Life Sciences segment of Danaher Corporation announced the completion of its new Therapeutic Oligonucleotide Manufacturing facility in Coralville, Iowa. The milestone marks a significant achievement in the company’s 35-year-history—its entrance into the therapeutics space—and enables IDT to manufacture products for research use through to current good manufacturing practice (cGMP) grade cell and gene therapy reagents to provide researchers with a single partner that can help them rapidly transition from the lab to therapeutic development.
The 41,000-square-foot-site will produce cGMP cell and gene therapy reagents, including single guide RNAs (sgRNAs) and donor oligos for homology-directed repair (HDR) with additional offerings to follow. These new capabilities and offerings will be supported with comprehensive documentation and testing, a support team, and regulatory guidance to help accelerate researchers’ path to the clinic.
“An increasing number of customers are seeking out IDT as a trusted partner for their CRISPR genome editing needs, and are asking us to be the provider that can help them bridge the gap from lab to clinic,” said Demaris Mills, president, IDT. “Now, with our new cGMP manufacturing facility, IDT can provide a complete CRISPR workflow—from design to analysis—that supports cell and gene therapy developers in all stages of therapeutic development, with the same support and expertise they have come to know from IDT. These new manufacturing capabilities, which have been informed by our decades of oligonucleotide synthesis manufacturing expertise, evolves IDT’s business model from Research Use Only to cGMP, and enables us to help more people.”
Danaher Vice President and Group Executive Chris Riley added, “The future of genomic medicine hinges on the industrialization of biology to make life-saving therapies more accessible to people. As a pioneer in genome editing, IDT’s continued investments will enable customers to rapidly move from clinical development to commercialization. This new facility is another significant milestone in IDT’s innovation journey, one we envision will have a profound impact in genomic medicine for years to come.”
The Therapeutic Oligo Manufacturing facility features ISO 8 cleanrooms, purification suites, chemical distribution and storage rooms, quality control labs, analytical lab space for product testing, ancillary and office spaces and shell space for future expansion. Manufacturing is performed in accordance with ICH Q7 cGMP standards for consistent and reliable quality. The controlled-access building features environmental controls for temperature, humidity and air pressure throughout, supported by an environmental program and continuous monitoring system. The addition of this new facility expands IDT’s global manufacturing footprint and enables the company to provide a range of manufacturing capabilities, including Research Use Only (RUO), large scale RUO, Engineering Run and cGMP (ICH Q7).
A Decade of CRISPR Innovation
Since 2015, IDT has continued to accelerate the pace of genomics with its complete portfolio of Alt-R™ CRISPR genome editing solutions. Its portfolio includes several first-to-market research products as well as solutions to meet researchers’ complete workflow—from design to analysis—to enable greater quality, simplicity, and cost efficiency. Last year, IDT launched the Alt-R™ HDR Donor Blocks, an improved solution for increasing homology-directed repair (HDR) rates in large fragment knock-in experiments, and expanded access to its Alt-R™ Custom CRISPR gRNA Libraries for drug discovery. In 2021, IDT also unveiled its rhAmpSeq™ CRISPR Analysis System, an end-to-end solution for characterizing and quantifying the full array of on- and off-target genome editing events in CRISPR research products.
IDT’s research and development teams have also been at the forefront of CRISPR innovation, with achievements that include the development of multiple proprietary CRISPR reagents such as IDT’s Alt-R™ S.p. HiFi Cas9 Nuclease and the Alt-R L.b. and A.s. Cas12a (Cpf1) Ultra enzymes. Notably, their groundbreaking research and collaborations with scientists around the globe has been published in more than 200 scientific journals as peer-reviewed articles, and is helping to shape the future of genomics and biotechnology.
IDT collaborated with M.A. Mortenson Company, a team led by OPN Architects and Barr Engineering Co. on the facility design and construction of its cGMP facility.
About IDT
For more than 35 years, Integrated DNA Technologies, Inc. (IDT) has been empowering genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, with the most advanced synthesis, modification, purification, and quality control capabilities available. Since its founding in 1987, IDT has progressed from a leading oligo manufacturer to a genomics solutions provider supporting key application areas such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. IDT manufactures products used by scientists researching many forms of cancer and most inherited and infectious diseases.
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Medical
businesswire | September 21, 2023
AbCellera announced that it has expanded its existing multi-target collaboration with Regeneron to discover therapeutic antibodies for up to eight targets selected by Regeneron, increased from the original four.
“Having successfully delivered on two challenging discovery campaigns under the original agreement, we are excited to expand the scope of our collaboration with Regeneron to include up to four additional targets,” said Carl Hansen, Ph.D., founder and CEO of AbCellera. “We look forward to using our antibody discovery and development engine to bolster Regeneron’s preclinical portfolio and help identify promising candidates for their programs.”
The collaboration, which began in March 2020, leverages AbCellera’s antibody discovery engine and Regeneron’s VelocImmune® mice to identify novel therapeutic antibodies. AbCellera has initiated programs for all four of the original targets, with Regeneron exercising its rights to advance antibody candidates into further preclinical development for the two programs that have been completed.
Under the terms of the agreement, Regeneron has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera receives research payments and is eligible to receive downstream clinical and regulatory milestone payments and royalties on net sales of products.
About AbCellera Biologics Inc.
AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
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Cell and Gene Therapy
prnewswire | September 14, 2023
Ceres Nanosciences, a global leader in developing wastewater testing methods based on its Nanotrap® technology, and Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that they are partnering to bring pathogen monitoring capabilities to laboratories around the world. Pathogen monitoring and analysis capabilities, including in wastewater, are designed to help public health institutions address regional biosecurity challenges.
Supported by the NIH RADx Initiative, Ceres developed their Nanotrap technology for robust, sensitive, and time-saving methods to detect a wide range of pathogens in wastewater samples and has deployed those methods to a network of testing sites in the United States. These sites provide wastewater testing services nationwide to deliver valuable public health data, such as information about the relative abundance of COVID-19 variant groups over time in a community's wastewater, to the CDC's National Wastewater Surveillance System and to state, local, and Tribal decision makers.
Recently, Concentric by Ginkgo, the biosecurity unit of Ginkgo Bioworks, as part of a CDC program, demonstrated in a study with partners from XPresCheck and Louisiana State University that coupling Ceres' aircraft wastewater testing methods with Concentric's analysis can enable early detection of variants of SARS-CoV-2. San Francisco International Airport was the first airport to announce that it will continuously monitor airplane wastewater samples as part of a CDC program operated by Concentric and XpresCheck.
Under the partnership between Ceres and Concentric, labs in countries where Concentric has biosecurity programs receive on-site training and the materials needed to implement the standardized and proven wastewater testing workflow from Ceres. Labs also receive biosecurity tools and data infrastructure to leverage automation, data analysis, bioinformatics capabilities, and other critical genomic sequencing technologies.
Together, Ceres and Concentric have set up labs in the Middle East and Africa through this collaboration, offering a cutting-edge approach to biosurveillance technologies and capacity building for labs around the world that are part of Concentric's global pathogen monitoring network.
"Under our NIH RADx Initiative, we demonstrated that we can quickly stand up improved wastewater testing capabilities for labs that are experts or novices in the space," said Robbie Barbero, Chief Business Officer at Ceres Nanosciences. "We are delighted now to be partnering with a global leader like Concentric to build a robust public health framework worldwide."
"Ceres Nanosciences has been a terrific partner in developing effective and innovative methods for identifying pathogens in wastewater," said Matt McKnight, General Manager, Biosecurity at Ginkgo Bioworks. "By combining their laboratory expertise with our global footprint, we are building a robust global biological radar to prevent, detect, and respond to biological threats."
About Ceres Nanosciences, Inc.
Ceres Nanosciences is a privately held company, located in Northern Virginia, focused on incorporating its proprietary Nanotrap® particle technology into a range of diagnostic and research use products and workflows. Nanotrap particles capture, concentrate, and preserve low abundance analytes from biological samples, enabling early and accurate detection of diseases. The Nanotrap particle technology was developed with support from the National Institutes of Health, the Defense Advanced Research Projects Agency, the Bill and Melinda Gates Foundation, Schmidt Futures, the Defense Threat Reduction Agency, the Centers for Disease Control and Prevention, and the Commonwealth of Virginia.
About Ginkgo Bioworks
Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats.
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