CELL AND GENE THERAPY
IndyGeneUS AI | May 20, 2021
Through collaborations, IndyGeneUS AI has acquired genomic analysis and testing capabilities. This pathogen sequencing capacity has emerged at a critical moment in efforts to improve genomic surveillance and monitor COVID-19 variant strains across the continent.
IndyGeneUS founder and CEO Yusuf Henriques emphasized the importance of this work. "COVID-19 and its variants pose a danger to the entire African continent, so we must act quickly. Our partners understand the urgency of this mission and are united with their cooperation."
Next-generation sequencing (NGS)-based genotyping, targeted sequencing, and comprehensive bioinformatics analysis are among the capabilities. Comparative genomic analysis, disease genetics, epigenomics, and genome mapping are some of the applications of our capabilities.
Bradford Wilson, Ph.D., Chief Scientific Officer at IndyGeneUS AI, said, "These capabilities are pivotal for the Continent and the future of precision medicine." "We are currently in talks with several large pharmaceutical firms that see the value of what we are developing to combat infectious and non-communicable diseases alike," he said.
In less than a year, IndyGeneUS AI has partnered with Kenyan organizations such as the KAVI Institute of Clinical Research at the University of Nairobi and Afya Rekod. We've also teamed up with Encrypgen, which has created a blockchain-encrypted marketplace for commercializing insights gleaned from our repository and compensating participants who contribute data.
IndyGeneUS has certainly understood the increasing need for infrastructure to sustain genomic surveillance activities by developing sequencing capabilities. Following the introduction of COVID-19 variant strains, the World Health Organization (WHO) and the African Centres for Disease Control (Africa CDC) established a network of laboratories last year to improve the continent's capacity to identify emerging variants of concern. More funding and infrastructure are needed for these initiatives. IndyGeneUS intends to accelerate sequencing capabilities across Africa by using public and private partnerships.
About IndyGeneUS AI
IndyGeneUS AI is a genomics company based in Nairobi is also developing the world's largest block-chain encrypted repository of African clinical and multi-omics data for disease prevention and diagnosis, drug discovery and development, clinical disease management, and the promotion of precision health equity. Mr. Yusuf Henriques, COO Dr. Wilmot Allen, and CSO Dr. Bradford Wilson formed IndyGeneUS. The company, which is owned by African Americans and Africans, has offices in Washington, DC, and a presence in South Africa through the Founder Institute. The Founder Institute is the world's largest pre-seed startup accelerator.
BioDuro-Sundia | November 09, 2021
BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, announced today it has entered into a definitive agreement to acquire a fully-operational 45,000 ft2 commercial oral solid dose drug product manufacturing facility located at 9601 Jeronimo Road, Irvine, CA. As part of the acquisition, BioDuro-Sundia will employ most of the current staff and provide continuous operations to support production of multiple existing products through a commercial supply agreement. Subject to customary closing conditions, BioDuro-Sundia will assume operations on January 1, 2022.
The Jeronimo facility is located in Irvine, California on the same campus as BioDuro-Sundia’s first US-based commercial facility, announced in August 2021. The deal includes an additional 25,000 ft2 of future space with combined facilities representing ~100,000 ft2 holding a supply capacity > 4 billion doses annually. Commercial production capabilities include aqueous and organic solvent process for fluid bed and coating capabilities, amorphous solid dispersion, along with multiple high speed tableting and encapsulation machines.
“The continuity of the operation, including a highly experienced team and established processes, allows a seamless transition for commercial manufacturing in a facility with outstanding production track record and audit history But, we are also adding new commercial-scale capabilities, such as spray dry dispersion and hot melt extrusion, which establish us as a top provider for amorphous solid dispersion manufacturing in North America.”
Alex Rodriguez, GM of the Irvine Facility at BioDuro-Sundia
“The acquisition of these commercial drug production facilities is a significant milestone in our 25-year history pioneering bioavailability enhancement for oral solid dosage forms, and a credit to our team’s dedication to quality operations, client satisfaction, and growth,” said Kent Payne, who led the acquisition in his role as President, Development and Manufacturing US/EU at BioDuro-Sundia. “It is also representative of our commitment to clients across the company and the investments we continue to make to grow capacity, establish new technology, and help our partners achieve success. We look forward to supporting our commercial-stage clients with quality drug product manufacturing, as we do all of our clients who entrust us with critical programs from discovery to development to manufacturing.”
BioDuro-Sundia’s US-based clinical development facility is located only an hour drive south in San Diego, California. The development operation has a track record of 1,000+ clinical programs, specializing in solubility enhancement leveraging amorphous solid dispersions.
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,000 employees and 10 global sites.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.
BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.
About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of June 30, 2020, had $58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.
About Bridgewest Business Group
Founded in 1999, The Bridgewest Business Group is a closely held investment company that seeks to create long term value through application of superior industry knowledge, operational expertise and significant financial resources to attractive investment opportunities. The Group structures its global investments across four functional areas including private equity, real estate, capital markets and financial services. The Group's private equity investments are primarily in biotech, wireless communications, infrastructure for IoT, and semiconductor. Bridgewest is based in San Diego, CA and has investments across the USA, Europe, Asia and Australasia.
CELL AND GENE THERAPY
Ocean Genomics, Geninus Inc | March 30, 2021
Ocean Genomics (Pittsburgh, PA), a world chief in AI-based gene expression analysis and RNA biomarker development, and Geninus (Seoul, South Korea), a main full-administration genomics laboratory, report an essential association with the end goal of co-creating RNA-based biomarkers and propelling exploration and clinical applications with emergency clinic, scholastic and biotechnology customers.
The two organizations will dispatch in Korea Ocean Genomics' high level AI-based transcriptome analysis and biomarker stage (txome.ai) as both a cloud-put together and with respect to premises arrangement. Geninus will use the txome.ai stage to extend its CancerSCAN clinical diagnostics stage for its clinic clients, and for biomarker revelation administrations with scholastic and biotechnology customers. Ocean Genomics and Geninus will likewise accomplice on the co-development of a progression of RNA-educated multidimensional biomarkers for research and clinical use.
“We are excited to embark on this partnership with Geninus” said Carl Kingsford, co-founder and CEO, Ocean Genomics. “Ocean Genomics’ expertise in AI and computational method development, together with Geninus’ translational experts and access to data is a powerful combination. Working together, we can advance the field and enhance the uses of RNA biomarkers in clinical and research applications – and provide essential insights for clinicians who care for cancer patients.”
Dr. Woong Yang Park, CEO, Geninus, said, “Genome analysis for precision cancer medicine is becoming an essential process in hospitals. Gene expression analysis on tumor tissue RNA can deliver critical information for targeted therapy and immunotherapy. We expect to advance precision medicine by incorporating Ocean Genomics’ txome.ai into Geninus’ clinical diagnostics platform, CancerSCAN. We look forward to working with Ocean Genomics in co-developing biomarkers and expanding services to our academic and biotechnology customers.”
About Ocean Genomics, Inc.
Ocean Genomics’ mission is to enable drug development and personalized medicine by combining AI with advanced gene-expression analysis to determine rich gene expression signatures and develop RNA-informed multidimensional biomarkers. DNA is a predictor of what might happen in the future, while RNA reveals what’s happening now, making it an essential component in drug development, screening and monitoring, diagnosis and treatment selection. Analyzing RNA requires far more advanced software and computational methods than analyzing DNA.
Ocean Genomics provides the required specialized expertise in AI and transcriptomic analysis and advanced computational software solutions required to power discovery and development programs with life sciences companies and academic researchers. Ocean Genomics provides a self-service, fully configured, cloud-based platform, txome.ai, which provides advanced transcriptome analysis and biomarker generation.
About Geninus Inc.
Geninus provides clinical genome analysis solutions for precision medicine clinics. CancerSCAN, a cancer genome diagnostics platform, is used to inform personalized cancer treatment with targeted therapeutics and immunotherapy in major hospitals in Korea and Japan. CancerSCAN includes an information management system, a bioinformatics pipeline, variant annotation, clinical reports, and datacenter. OncoSTATION, a user interface for CancerSCAN, can be installed within hospital information systems. In addition, Geninus operates a single cell genome analysis platform called Celinus for biomarker discovery. Through collaborations with clinicians and pharmaceutical companies, Celinus can unearth new druggable targets or diagnostic markers in tumor microenvironment cells.