Labcorp | July 04, 2022
Labcorp a leading global life sciences company, announced that it is enhancing its central laboratory presence and drug development capabilities in Japan through an expansion of CB Trial Laboratory, the central laboratory co-managed by Labcorp Drug Development and BML, a leading Japanese provider of clinical laboratory testing services.
Extending their strategic relationship that dates back more than a decade, Labcorp Drug Development and BML will begin work on a new laboratory facility in the city of Kawagoe, Saitama, expanding capacity and services for pharmaceutical and biotechnology clients. This will bolster Labcorp Drug Development’s central laboratory services offerings in Japan and sets the stage for a continued acceleration of companion diagnostic capabilities.
“Labcorp Drug Development remains committed to growing its Japanese operations and services through continued expansion and partnerships. Broadening our work with BML and increasing our laboratory footprint means we will be able to offer shorter turnaround times, superior in-country sample management and full lab testing services for global clinical trials in Japan. This will benefit patients, clients and health care providers by providing them with the information needed to make key decisions.”
Honggang Bi, senior vice president and head of Asia-Pacific for Labcorp Drug Development
The new facility will be located near BML’s General Laboratory in Kawagoe where the current CB Trial Laboratory is located, providing over 4,000 square meters of dedicated space for global clinical trials managed by Labcorp Drug Development. The new space will be greater than five times the size of the current facility, with additional capabilities such as genomics, microbiology and companion diagnostics in addition to expanded offerings in current lab capabilities including flow cytometry, immunology, and anatomical pathology and histology. Completion of the expanded laboratory is expected by early 2025.
Through the planned laboratory expansion, Labcorp will advance biomarker and esoteric testing services, expand its companion diagnostics portfolio and deepen the integration with its clinical development services. In addition, the company will be able to intensify its focus on cell and gene therapy research and development, part of a broader commitment to precision medicine and fortifying the company’s position as an oncology leader.
“In collaborating with Labcorp, we are able to offer our pharmaceutical and biotechnology clients access to both comprehensive clinical laboratory testing and drug development opportunities,” said Dr. Kensuke Kondo, president of BML. “The laboratory expansion provides additional capabilities and capacity and opens the door to enriched services, more resources and better outcomes for our clients and patients.”
Labcorp and BML have successfully provided central laboratory services for global clinical trials in Japan since 2010 through kit production, sample logistics and laboratory operations at CB Trial Laboratory. Their partnership agreement was renewed in 2020.
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 reported revenue of $16 billion in FY2021.
Specifica | June 03, 2022
Specifica, a privately held antibody engineering company focused on innovative in vitro antibody libraries and discovery tools, announced an agreement with the global healthcare company Sanofi under which Specifica’s patented Generation 3 Antibody Discovery Platform will be transferred to Sanofi. The comprehensive technology transfer package will enable the integration of Specifica’s Gen 3 platform into Sanofi’s antibody discovery programs.
“We are absolutely delighted to partner with Sanofi and their cutting-edge antibody discovery teams by providing our complete antibody discovery platform through a combination of Gen 3 libraries, antibody optimization solutions, and integrated discovery tools. We look forward to the realization of our collaboration with Sanofi as they continue to pursue the development of life-changing treatments.”
Ken Sharples, CEO and co-founder of Specifica
Specifica’s Gen 3 libraries combine clinically validated antibody frameworks with compatible binding loop sequences (CDRs) from natural human antibodies that have been purged of sequence-based developability liabilities. The Gen 3 discovery platform consistently yields a broad diversity of specific and developable antibodies with very high affinities, thereby avoiding downstream hit-to-lead optimization bottlenecks such as affinity maturation and developability optimization.
Specifica is a rapidly growing antibody engineering company specializing in the creation of exceptional antibody libraries, using next-generation sequencing for quality control at all steps of construction and validation. Specifica’s patented Generation 3 Antibody Library Discovery Platform yields drug-like antibodies directly from selections, minimizing the need for downstream affinity and biophysical engineering. Specifica provides its partners with exclusive libraries, each created from a unique donor diversity set not used for any other library, ensuring that each Gen 3 library is one of a kind. Specifica offers antibody library platforms in Fab, scFv and VHH formats. In addition to in-house antibody library designs, Specifica also collaborates closely with partners to create custom libraries in which essential elements are optimized according to partner needs. The power of the Generation 3 Platform may be accessed by engaging Specifica to execute antibody discovery and optimization campaigns, or by full transfer of the platform technology. Additionally, Specifica recently introduced AbXtractTM, a powerful suite of antibody informatics tools, through its software partner OpenEye. Specifica is headquartered in Santa Fe, New Mexico
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
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.