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Expansion of BioPharma: Opportunities and Investments

Kutubkhan Bohari | July 12, 2022 | 885 views | Read Time : 01:00 min

Expansion of
Biopharmaceutical innovations are among the most ingenious and refined achievements of modern medical science. New concepts, techniques, and therapies are emerging, such as the cell therapy Provenge, which can be used to treat cancer, and gene therapies, which provide even more amazing promises of disease remission and regenerative medicine.

In addition, the COVID-19 pandemic has caused a huge boom in the pharmaceutical industry. This is because more and more attention is being paid to increasing manufacturing capacity and starting new research on drug development.

Biopharma: Leading the Way in the Pharma Sector

In the past couple of years, the biopharmaceutical sector has deepened its roots across the medical and pharmaceutical industries, on account of the transformation of pharmaceutical companies towards biotechnology, creating opportunities for growth.

Also, growing advancements in technologies such as 3D bioprinting, biosensors, and gene editing, along with the integration of advanced artificial intelligence and virtual and augmented reality are estimated to further create prospects for growth.

According to a study, the biopharmaceutical sector makes nearly $163 billion around the world and grows by more than 8% each year, which is twice as fast as the traditional pharma sector.

Massive Investments Directed Towards Biopharma

Investing in biotech research and development (R&D) has yielded better returns than the pharma industry average. Hence, a number of pharmaceutical companies are shifting their presence toward biopharma to capitalize on the upcoming opportunities by investing in and expanding their biotechnology infrastructure.

For instance, Thermo Fisher Scientific Inc., an American manufacturer of scientific instrumentation, reagents and consumables, and software services, announced an investment of $97 million to expand its bioanalytical laboratory operations into three new locations in the U.S. With this investment, the company will add 150,000 square feet of scientific workspace and install the most advanced drug development technologies to produce life-changing medicines for patients in need.

Spotlight

Green Scientific Labs

Green Scientific Labs, LLC (“GSL”) is a leading hemp and marijuana testing laboratory based in Davie, Florida. GSL tests cannabis and cannabis derived products to ensure product quality and consumer safety. Founded in 2018, GSL is ISO 17025:2017 certified and holds a Certified Marijuana Testing Laboratory (CMTL) license from the Florida Department of Health Office of Medical Marijuana Use.

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The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

Read More

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Article | February 11, 2020

In today’s biotechnology landscape, to be competitive, meet regulations, and achieve market demands, “we must apply Bioprocessing 4.0,” said Igor Fisch, PhD, CEO, Selexis. In fact, in the last decade, “Selexis has evolved from cloning by limiting dilution to automated cell selection to nanofluidic chips and from monoclonality assessment by statistical calculation to proprietary bioinformatic analysis,” he added. Single-use processing systems are an expanding part of the biomanufacturing world; as such, they are a major component of Bioprocessing 4.0. “At Selexis, we use single use throughout our cell line development workflow. Currently, we have incorporated single-use automated bioprocessing systems such as ambr® and the Beacon® optofluidic platform for accelerated cell line development. By using these systems and optimizing our parameters, we were able to achieve high titers in shake flasks. Additionally, the Beacon systems integrate miniaturized cell culture with high-throughput liquid handling automation and cell imaging. This allows us to control, adjust, and monitor programs at the same time,” noted Fisch.

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NanoString Platforms Advance Groundbreaking Studies of Immune Response in Pig-to-Human Organ Transplants

Businesswire | August 22, 2023

NanoString Technologies, Inc. a leading provider of life science tools for discovery and translational research, The seminal research led by Alexander Loupy, MD, Ph.D., in cooperation with a global medical team, unravels the complex molecular characteristics of antibody-mediated rejection following the first and second-ever pig-to-human kidney transplants that occurred in 2021 at NYU Langone Transplant Institute. In an accompanying Lancet commentary, scientists praised the team “for laying the foundation for deeper assessment of xenoimmunology and establishing immunological research pathways to advance xenotransplantation.” They also commented on the importance of “state-of-the-art spatial techniques” to decipher transcriptional immune activation. “We gained vital data and, for the first time ever, we were able to see what is happening immunologically in defined regions of the tissue,” said Dr. Loupy. “This data, enabled by NanoString’s platforms and an Allo - Xeno gene expression repository, allowed us to understand both the similarities and the novel aspects underpinning organ rejection in xenograft transplantation compared to human organ transplantation. NanoString’s nCounter and GeoMx instruments harmonized to create a holistic view of the immune response.” Researchers from the Paris Institute for Transplantation and Organ Regeneration, University of Paris, France’s National Institute of Health and Medical Research contributed to the study. Xenotransplantation, the process of transplanting organs from animals to humans, is a crucial area of research dedicated to addressing the profound shortage of healthy human organs available for transplant patients. The groundbreaking experimental transplant surgeries performed by Dr. Robert Montgomery at NYU since 2021 involve patients in a state of brain death. Their families and ethical committees have consented to artificially maintain blood circulation during the transplants to advance scientific knowledge on xenotransplantation with the hope of offering more healthy organs for future patients. The research team, including co-first authors of The Lancet study, Dr. Valentin Goutaudier and Dr. Alessia Giarraputto characterized the human immune response to the porcine kidney using bulk tissue transcriptome profiling on the nCounter Analysis System. Scientists used the nCounter Human Organ Transplant Panel, a process NanoString developed with the Banff International Classification Consortium. It is used by nearly one hundred global research institutions. The panel was adapted to xenotransplants by using bioinformatics-based pig and human gene sequences with homologies alignment. This analysis revealed a molecular architecture of antibody-mediated rejection, including interferon-gamma response, endothelial activation, macrophage activation, and injury repair response in the xenografts. The GeoMx Digital Spatial Profiler was used next to isolate the immune response to specific regions of the kidney. The GeoMx Whole Transcriptome Assay revealed that antibody-mediated injury was mainly located in the glomeruli of xenografts, with significant enrichment of transcripts associated with monocytes, macrophages, neutrophils, and NK cells. Drs. Loupy and Montgomery say their findings represent a treasure trove of new information for optimizing genetically modified pig models that may be useful in developing more advanced immunosuppressive treatments for future recipients of xenografts. “An estimated 100,000 people are waiting for organ transplants in the United States. Thousands die on the wait list. Numbers like these drive us at NanoString to provide researchers with the tools they need to find innovative solutions to solve extraordinary medical challenges,” commented Brad Gray, President and CEO of NanoString. “We congratulate Dr. Loupy and his extended team on their findings and celebrate the on-going successful studies in humans.” About NanoString Technologies, Inc. NanoString Technologies, is a leader in spatial biology, offers an ecosystem of innovative discovery and translational research solutions, empowering our customers to map the universe of biology. The GeoMx® Digital Spatial Profiler is a flexible and consistent solution combining the power of whole tissue imaging with gene expression and protein data for spatial whole transcriptomics and proteomics. The CosMx™ Spatial Molecular Imager is a single-cell imaging platform powered by spatial multiomics enabling researchers to map single cells in their native environments to extract deep biological insights and novel discoveries from one experiment. The AtoMx™ Spatial Informatics Platform is a cloud-based informatics solution with advanced analytics and global collaboration capabilities, enabling powerful spatial biology insights anytime, anywhere. At the foundation of our research tools is our nCounter® Analysis System, which offers a secure way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision.

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Vial Announces Strategic Partnership to Build CFR Part 11 Open Source e-Signature Platform with Documenso

PRNewswire | August 24, 2023

Vial, a global tech-driven CRO providing next-generation clinical trial management services, has announced a partnership with Documenso, an innovative open-source digital signing platform. The collaboration marks a significant step forward in revolutionizing document signing practices within the life science sector, providing a compelling alternative to traditional solutions like DocuSign. In an era where digital transformation is reshaping industries, Vial's partnership with Documenso is set to drive innovation in electronic document management, particularly in meeting the rigorous requirements of CFR Part 11 compliance. CFR Part 11 is a section of the Code of Federal Regulations (Title 21) established by the FDA. It lays out guidelines for electronic recordkeeping and signatures, ensuring data integrity and security in regulated sectors such as pharmaceuticals, biotechnology, and medical devices. "Vial's unwavering commitment to technological advancement has always been at the core of our mission to reimagine clinical trials. Our partnership with Documenso signifies an exciting leap towards innovation by addressing a critical need in the life science sector. Currently, very few providers offer solutions that align with the rigorous requirements of 21 CFR Part 11. We aim to collaborate with Documenso to develop one of the industry's first open-source document-signing products that meet the demands of 21 CFR Part 11. Together, we are poised to reshape how critical documents are managed and signed, driving us closer to a future where technology empowers every facet of scientific progress," said Simon Burns, CEO and Co-Founder of Vial. Vial's mission is to reimagine clinical trials to empower scientists to cure all human disease. Vial's driver for accomplishing this mission is applying a technology-forward approach. By deploying technology at every step, Vial is able to drive efficiencies in speed and cost savings for innovative biotech companies of all sizes. The Vial CRO distinguishes itself by leveraging its Vial Technology Platform, TrialOS, combining site start-up, visit data capture, and study analytics into one connected system. These best-in-class CRO services, combined with top vendor partnerships like Documenso, help accelerate the development of new therapies and devices for sponsors and patients. On the partnership, Timur, CEO, and Co-Founder of Documenso, commented, "Documenso is more than just a digital signing solution; it's a global commodity designed for longevity and scalability. We're excited to work alongside Vial in this endeavor, leveraging the power of Commercial Open Source (COSS) principles to provide a robust alternative to traditional solutions." About Vial Vial is a tech-first, next-generation CRO that promises faster and higher-quality execution of trials for less cost. The Vial Contract Research Organization (CRO) delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial's technology platform combines modern, intuitive eSource, EDC, and ePRO into one connected system, streamlining site processes and enabling considerable efficiencies. Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO). Vial is a San Francisco, California-based company with over 100+ employees. About Documenso Documenso is a groundbreaking open-source digital signing platform and alternative to traditional solutions like DocuSign. With a strong emphasis on customization and scalability, Documenso seamlessly integrates into business operations, offering extensive options for adaptation and an open API. Documenso was built for longevity and scale by embracing the capital efficiency and inclusiveness of the Commercial Open Source (COSS) movement. Documenso aims to create a global standard for digital signing that prioritizes inclusiveness and innovation.

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Repligen Announces Agreement to Acquire Fluid Management Innovator Metenova

globenewswire | September 28, 2023

Repligen Corporation a life sciences company focused on bioprocessing technology leadership, announced that it has entered into a definitive agreement to acquire privately-held Metenova AB (Metenova) of Mölndal, Sweden. Metenova is projected to generate revenues of $24 million to $25 million for fiscal year 2023, led by the success of its magnetic mixing and drive train technologies that are widely used by global biopharmaceutical companies and contract development and manufacturing organizations (CDMOs). The company recently entered the single-use mixing market with the launch of its MixOne platform, leveraging the success of its existing stainless steel (repeat-use) product line. Metenova is expected to contribute approximately $5 million in revenue to Repligen in the fourth quarter of 2023, and to contribute $25 million to $27 million in revenue in 2024, with 20%-25% revenue growth in 2025 forward. The acquisition is anticipated to be accretive to Repligen’s adjusted gross and operating margins in 2024, and to be accretive to adjusted earnings per share in 2025. Over the past decade, Metenova has established market leadership through design innovation in magnetic mixing, with a state-of-the-art suite of both stainless steel and single-use impellers (mixer heads) and drive trains – key components of mixing vessels. The company offers a broad range of products, including high power solutions for efficient media and buffer preparation, and low shear solutions for gentle mixing of sensitive proteins. Metenova’s high performance aseptic mixing technologies are designed to minimize product damage and improve product yield and product consistency, contributing to improved ROI for customers. The company’s solutions are applicable to a wide range of small molecule and large molecule therapeutics and vaccines, including monoclonal antibodies, recombinant proteins, and cell and gene therapies. Tony J. Hunt, President and Chief Executive Officer at Repligen said, “The addition of Metenova further strengthens our Fluid Management portfolio, with a product line that expands on the market success of our systems and fluid management assemblies and complements our recently acquired single-use bag business from FlexBiosys. We are excited to welcome the Metenova team to Repligen and we look forward to further developing and integrating their differentiated magnetic mixing technologies into our portfolio.” Johan Westman, Chief Executive Officer at Metenova said, “We have made tremendous progress over the last ten years, building a market leading mixing portfolio. We are now at a stage in our development where we can benefit from more rapid expansion into the single-use market where many of our customers are scaling today. Repligen is the ideal partner for us to take this next step of growth and we look forward to working with our colleagues at Repligen to drive additional global demand for our single-use mixing products, while continuing to advance innovative single-use solutions for the industry.” About Metenova AB Metenova is a leading innovator and manufacturer of magnetic mixers for pharmaceutical and biotechnology use. We provide aseptic cutting-edge mixing technology for critical applications. Sales are mainly performed by distributors in over 30 countries with approximately one-third of sales in North America, one-third of sales in Europe and one-third of sales in Asia/ROW. Metenova recently entered the single-use mixing market with the launch of its MixOne platform, leveraging the success of its existing repeat-use (stainless steel) product line. Metenova is headquartered in Mölndal in the Gothenburg area and has approximately 50 employees. About Repligen Corporation Repligen Corporation is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs. We are “inspiring advances in bioprocessing” for the customers we serve; primarily biopharmaceutical drug developers and contract development and manufacturing organizations (CDMOs) worldwide. Our focus areas are Filtration and Fluid Management, Chromatography, Process Analytics and Proteins. Our corporate headquarters are in Waltham, Massachusetts, and the majority of our manufacturing sites are in the U.S., with additional key sites in Estonia, France, Germany, Ireland, the Netherlands and Sweden.

Read More

MedTech, Medical

NanoString Platforms Advance Groundbreaking Studies of Immune Response in Pig-to-Human Organ Transplants

Businesswire | August 22, 2023

NanoString Technologies, Inc. a leading provider of life science tools for discovery and translational research, The seminal research led by Alexander Loupy, MD, Ph.D., in cooperation with a global medical team, unravels the complex molecular characteristics of antibody-mediated rejection following the first and second-ever pig-to-human kidney transplants that occurred in 2021 at NYU Langone Transplant Institute. In an accompanying Lancet commentary, scientists praised the team “for laying the foundation for deeper assessment of xenoimmunology and establishing immunological research pathways to advance xenotransplantation.” They also commented on the importance of “state-of-the-art spatial techniques” to decipher transcriptional immune activation. “We gained vital data and, for the first time ever, we were able to see what is happening immunologically in defined regions of the tissue,” said Dr. Loupy. “This data, enabled by NanoString’s platforms and an Allo - Xeno gene expression repository, allowed us to understand both the similarities and the novel aspects underpinning organ rejection in xenograft transplantation compared to human organ transplantation. NanoString’s nCounter and GeoMx instruments harmonized to create a holistic view of the immune response.” Researchers from the Paris Institute for Transplantation and Organ Regeneration, University of Paris, France’s National Institute of Health and Medical Research contributed to the study. Xenotransplantation, the process of transplanting organs from animals to humans, is a crucial area of research dedicated to addressing the profound shortage of healthy human organs available for transplant patients. The groundbreaking experimental transplant surgeries performed by Dr. Robert Montgomery at NYU since 2021 involve patients in a state of brain death. Their families and ethical committees have consented to artificially maintain blood circulation during the transplants to advance scientific knowledge on xenotransplantation with the hope of offering more healthy organs for future patients. The research team, including co-first authors of The Lancet study, Dr. Valentin Goutaudier and Dr. Alessia Giarraputto characterized the human immune response to the porcine kidney using bulk tissue transcriptome profiling on the nCounter Analysis System. Scientists used the nCounter Human Organ Transplant Panel, a process NanoString developed with the Banff International Classification Consortium. It is used by nearly one hundred global research institutions. The panel was adapted to xenotransplants by using bioinformatics-based pig and human gene sequences with homologies alignment. This analysis revealed a molecular architecture of antibody-mediated rejection, including interferon-gamma response, endothelial activation, macrophage activation, and injury repair response in the xenografts. The GeoMx Digital Spatial Profiler was used next to isolate the immune response to specific regions of the kidney. The GeoMx Whole Transcriptome Assay revealed that antibody-mediated injury was mainly located in the glomeruli of xenografts, with significant enrichment of transcripts associated with monocytes, macrophages, neutrophils, and NK cells. Drs. Loupy and Montgomery say their findings represent a treasure trove of new information for optimizing genetically modified pig models that may be useful in developing more advanced immunosuppressive treatments for future recipients of xenografts. “An estimated 100,000 people are waiting for organ transplants in the United States. Thousands die on the wait list. Numbers like these drive us at NanoString to provide researchers with the tools they need to find innovative solutions to solve extraordinary medical challenges,” commented Brad Gray, President and CEO of NanoString. “We congratulate Dr. Loupy and his extended team on their findings and celebrate the on-going successful studies in humans.” About NanoString Technologies, Inc. NanoString Technologies, is a leader in spatial biology, offers an ecosystem of innovative discovery and translational research solutions, empowering our customers to map the universe of biology. The GeoMx® Digital Spatial Profiler is a flexible and consistent solution combining the power of whole tissue imaging with gene expression and protein data for spatial whole transcriptomics and proteomics. The CosMx™ Spatial Molecular Imager is a single-cell imaging platform powered by spatial multiomics enabling researchers to map single cells in their native environments to extract deep biological insights and novel discoveries from one experiment. The AtoMx™ Spatial Informatics Platform is a cloud-based informatics solution with advanced analytics and global collaboration capabilities, enabling powerful spatial biology insights anytime, anywhere. At the foundation of our research tools is our nCounter® Analysis System, which offers a secure way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision.

Read More

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