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.
Societal CDMO, Inc. | July 21, 2022
Societal CDMO, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected to provide CDMO services to support the ongoing clinical development of a novel drug candidate in Europe. The compound is an oral solid dose anti-viral therapy product approved for the prevention and treatment of human immunodeficiency virus in select countries in Europe and Societal’s work is focused on supporting the expansion of the product’s indications.
Under terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material to support the initiation and execution of Phase 2 studies of the drug candidate. This work will include production, packaging and labeling of both the active compound and matching placebo for the study.
“This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalize on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the U.S. from other regions around the globe. We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe. We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.”
David Enloe, chief executive officer of Societal CDMO
About Societal CDMO
Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
BC Platforms | June 07, 2022
BC Platforms a leading provider of data and technology platforms for personalized medicine and drug development, will host a key, day-long, Precision Medicine and Data Science Conference in Singapore on 7 June 2022 to discuss how stakeholders can securely collaborate and enable the use of federated data at scale to empower precision medicine, population health, and preventive care initiatives in the region.
The event features preeminent local and international experts from healthcare, government, and academia, including Professor Patrick Tan, Executive Director of the Genome Institute of Singapore, Associate Professor Neerja Karnani, BioInformatics Institute A*STAR and Dr Shay Ben-Shachar, Director of Precision Medicine and Genomics at Clalit Research Institute, Israel. It is part of BCP's efforts to support the growth of precision medicine activities in Asia Pacific.
"Access to connected, secure data is a key pillar in overall healthcare development. High quality clinical and genomics information is foundational to predictive and preventive clinical care as well as drug development. Today, real-world data generated from Asian countries is not represented well enough and data diversity is key to solving the most pressing research questions. At BC Platforms we recognize that Asian countries continue to remain under-represented in global life science research; so it is important for healthcare systems in the region to collaborate, build highly secure, enabling technologies and ensure local legislation is supportive of real-world data initiatives. It will allow the whole ecosystem to stay in front of the development, and our vision focuses on personalized care models for patients in this region."
Mr Tero Silvola, Chief Executive Officer of BC Platforms
The company had expanded its R&D operations in Singapore earlier this year and partnered with SingHealth, Singapore's largest public healthcare group. Parties aim to build a series of research projects and by doing so accelerate relevant clinical research with pressing targets on diseases prevalent in the Asian population, including but not limited to cancer and cardiovascular diseases. This highly visible partnership is part of BC Platforms' rapidly growing data partner network for secure and regulatory compliant sharing of real-world data. The BCRQUEST.com global partner network now comprises 33 million patient lives from 37 data partners on five continents.
While BC Platforms has been active in Singapore since 2019, it plans to ramp up activities and continue to build its presence in the region as it continues to develop and deploy safe and secure infrastructure for healthcare data. The company is also focusing on partnerships with local and regional healthcare and research institutions to strengthen translational research capabilities in Asia Pacific and improve care outcomes for patients in the region.
About BC Platforms
BC Platforms is a global leader in providing a powerful data and technology platform for personalised medicine and drug development, accelerating the translation of insights into clinical practice. Our technology drives the infinite loop between personalised care and research discoveries, leveraging latest science, deep technical expertise, strategic partnerships, and harmonized, diverse data collections. Our high performing genomic data discovery and analytics platform enables flexible data integration, secure analysis, and interpretation of molecular and clinical information.