Sanofi opens digital manufacturing facility in the US

Pharmaceutical Technology | October 15, 2019

French pharmaceutical giant Sanofi has opened a digital manufacturing facility at Framingham in Massachusetts, the US for continuous production of biologics. The facility will use intensified technology to link the production process with research and development. The company expects the approach to improve the commercialisation of drugs. Sanofi notes that the facility will boost its strategy to focus on biologics, supporting the transformation of its R&D pipeline. Sanofi global industrial affairs executive vice-president Philippe Luscan said: “Our Framingham facility leads the way in delivering the next generation of biologics manufacturing, leveraging intensified, continuous processing in a fully integrated digitally powered facility. “This opening demonstrates we are at the leading edge of innovation and manufacturing excellence, helping us to shape the future of both our company and the industry.”

Spotlight

A major step towards personalized medicine was achieved in early 2014 when the first report of sequencing a human genome for $1,000 was announced—hailed by some as one of the greatest scientific and medical achievements of the last decade.

Spotlight

A major step towards personalized medicine was achieved in early 2014 when the first report of sequencing a human genome for $1,000 was announced—hailed by some as one of the greatest scientific and medical achievements of the last decade.

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PostEra spearheads AI-driven drug discovery collaboration to develop antiviral therapeutics with initial $68M in NIH funding

PostEra | May 19, 2022

PostEra, a biotechnology company specializing in machine learning for preclinical drug discovery, announced a multi-year collaboration with the National Institutes of Health to develop small molecule antiviral therapeutics to prevent pandemics. The center will receive initial funding of $68M. PostEra co-leads this initiative with the Drugs for Neglected Diseases Initiative, a global charity with expertise in drug development for global equitable access, and the Memorial Sloan Kettering Cancer Center. As part of the National Institutes of Health's National Institute of Allergy and Infectious Diseases Antiviral Program for Pandemics, the AI-driven Structure-Enabled Antiviral Platform (ASAP) consortium aims to discover dozens of lead compounds against key viruses of significant pandemic concern, such as flaviviruses (responsible for endemic diseases such as Dengue and Zika), picornaviruses (including potentially debilitating enteroviruses as well as other cold-causing viruses), and coronaviruses. ASAP will further deliver three IND-ready candidates which can be immediately ready for clinical evaluation in the event of a viral outbreak, so that future pandemics can be halted before severe outbreaks occur. The consortium is committed to making resulting antivirals globally and equitably accessible, so that no patient population is left behind. ASAP will use PostEra's end-to-end AI-first approach to accelerate the discovery process, generating molecules with optimised properties, designing rapid synthesis, and optimally prioritising experiments. In particular, AI approaches are tightly integrated into structural biology to realize next generation structure-based design. ASAP is built on the success of the COVID Moonshot project, a global open-science AI-driven initiative that began in March 2020 and rapidly identified antiviral drug candidates that target the main protease of the SARS-CoV-2 virus. "We are honored to be co-leading this consortium. We believe that our AI platform will accelerate the discovery of therapeutics that will prevent pandemics." Dr Alpha Lee, Chief Scientific Officer of PostEra, who co-founded COVID Moonshot About PostEra PostEra was founded in 2019 and its technology is built on pioneering academic research done by its founding scientists. PostEra's technology addresses some of the key challenges in drug discovery R&D by integrating molecular design with chemical synthesis. PostEra advances small molecule programs through partnerships with biopharma, working on its own internal pipeline, and also offering some of its synthesis technology via its Manifold web platform. PostEra also helped launch the world's largest open-science drug discovery effort; COVID Moonshot, along with an NIH-funded antiviral research center for the prevention of future pandemics.

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Labcorp Enhances Clinical Trial and Drug Development Capabilities Through Real World Data Collaboration With HealthVerity

Labcorp® | June 23, 2022

Labcorp® a leading global life sciences company, announced a new collaboration with HealthVerity, Inc., the leader in Identity, Privacy, Governance, and Exchange (IPGE) for real-world data that will expand Labcorp’s comprehensive, end-to-end drug development and clinical trial programs. HealthVerity’s IPGE platform, an integrated technology and RWD infrastructure, enables Labcorp Drug Development and other participating companies to access fully interoperable, HIPAA-compliant data from the U.S.’s largest ecosystem1 of health care and consumer data. “This collaboration allows Labcorp to expand existing end-to-end solutions for drug and diagnostics development, commercialization and clinical trial efforts to include large-scale access to real-world data for research applications. By applying advanced analytics, Labcorp can help its clients improve their processes and reach better outcomes. Our substantial repository of test results can also help study sponsors more quickly and accurately assess patient eligibility for clinical trials, enroll patients faster and accelerate the availability of new medicines.” Dr. Paul Kirchgraber, CEO of Labcorp Drug Development Now more than ever, study sponsors are seeing the potential of RWD to yield longitudinal patient insights before, during and after trials. With more predictive analytics and artificial intelligence applications requiring comprehensive and fully interoperable RWD, Labcorp can align de-identified patient data with ten times greater accuracy2 than industry alternatives by using the HealthVerity IPGE platform. In addition, access to HealthVerity’s RWD with on-demand de-identification and data linkage capabilities reinforces Labcorp’s ability to be a trusted source of information for its clients. "Fragmentation of patient data is at an all-time high, and the goal is no longer just connecting this data," said Andrew Kress, CEO of HealthVerity. "Rather, the goal is making data more accessible and useful for gaining a detailed understanding of patient journeys. With analytics and applications requiring more frictionless access to the data itself, the HealthVerity IPGE platform stands alone in offering the ability to combine transaction-level patient data in a de-identified, fully interoperable manner, and delivering it directly into the client's applications of choice." About Labcorp Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16 billion in FY2021. About HealthVerity Pharmaceutical manufacturers, payers, and government organizations have partnered with HealthVerity to solve some of their most complicated use cases through transformative technologies and real-world data infrastructure. The HealthVerity IPGE platform, based on the foundational elements of Identity, Privacy, Governance, and Exchange, enables the discovery of real-world data across the broadest healthcare data ecosystem, the building of more complete and accurate patient journeys and the ability to power best-in-class analytics and applications with flexibility and ease. Together with our partners, HealthVerity has built the modern way to data for the health insights economy.

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Curia and Replicate Bioscience Enter Strategic Collaboration to Create Groundbreaking Development Platform for Self-Replicating RNA (srRNA)

Curia | June 10, 2022

Curia, formerly AMRI, a leading contract research, development and manufacturing organization, and Replicate Bioscience, a company pioneering ways to prevent drug resistance in cancer and to treat autoimmune and inflammatory disorders and other diseases using self-replicating RNA (srRNA), today announced that they will collaborate on a robust development platform for Replicate’s srRNA therapeutics. As part of the collaboration, Curia’s experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale (8L), which can be used in Phase 1 through pivotal clinical trials. Curia’s global mRNA development and manufacturing facility is ISO-13485 certified and located near Boston, Massachusetts. This facility also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays. Additional Curia facilities support manufacture of srRNA through commercial production scales. “Replicate’s approach to srRNA is unique, in that we create our own virally-derived synthetic vectors to customize srRNAs to deliver specific proteins,” said Replicate Co-founder and Chief Development Officer Andrew Geall, Ph.D., who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics, and Precision Nanosystems. “This customization has important therapeutic. advantages—versatility of application, lower dosing, and longer duration of therapeutic effect compared to other RNA modalities—but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs. Curia’s unprecedented expertise in process development and end-to-end integration of longer RNAs makes them a perfect partner for us as we transition from research into clinical development and the production of our srRNA for trials in patients.” “The manufacture of these longer mRNAs is more technically challenging than non-replicating mRNAs and to date we have succeeded with mRNAs up to 16,000 bases. Curia’s platform offers versatility and streamlined manufacturing times that can handle such complex molecules. Our collaboration with Replicate Bioscience is enabling us to create entirely new methods of manufacturing longer RNAs. We have built our platform from the ground up, using our combined experience in biologics and chemistry to create end-to-end solutions covering mRNA synthesis, lipid synthesis, formulation, and liquid nanoparticle fill-finish. We are proud to apply our capabilities and expertise to support the Replicate Bioscience team and its innovative approach.” Norman Garceau, Ph.D., Vice President, Global R&D Technology, Curia About Curia Curia, formerly AMRI, is a leading contract research, development and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s 3,700 employees at 29 locations across the U.S., Europe and Asia help its customers advance from curiosity to cure. Learn more at CuriaGlobal.com. About Replicate Bioscience Replicate Bioscience, an ATP company, is designing and delivering srRNA immunotherapies to revolutionize the practice of medicine and improve and save lives. Replicate applies advanced srRNA technology in its work to prevent drug resistance in cancers. The company is also developing srRNA injections for sustained therapeutic protein expression to treat autoimmune and inflammatory disorders and other conditions. Replicate believes that srRNA will bring about the next big breakthroughs in RNA therapeutics and is working to realize the promise of srRNA for all patients.

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