Monthly Archives: July 2022

Technology in the service of health. Once again, technological progress has resulted in obvious benefits to humans; In this case, in health matters. a group of scientists has developed a robotic system based on artificial intelligence that automatically determines what are the optimal conditions for the replacement layers of the retina to grow Required in various treatments aimed at restoring vision.

During the last experiment, The system underwent a trial and error process covering a total of 200 million possible configurations and managed to dramatically improve cell culture viability Regenerative medicine is essential to the therapy. A feat that exemplifies how the automated design and execution of scientific experiments can increase the efficiency and speed of research in countless fields such as biology.

Traditionally, research in regenerative medicine has required a number of experiments that require a great deal of time and work. especially, Creating specific tissues from stem cells a process called induced cell differentiation takes months of work, and the degree of success depends on a wide range of variables., Finding the optimal type, dosage and timing of reagents as well as optimal physical variables, such as cell transfer time or temperature, is difficult and requires an enormous amount of testing.

Thus, to make this process more efficient and practical, a research team led by Genki Kanda from the RIKEN Institute in Japan set out to Develop an autonomous experimental system that can determine optimal conditions and grow functional retinal pigment layers from stem cells, For this Retinal pigment epithelial cells were selected Because the degeneration of these cells is a common aging-related disorder that makes people unable to see. More importantly, transplanted retinal pigment epithelial layers have already shown some clinical success.

For autonomous experiments to be successful, the robot must perform the same series of precise movements and manipulations over and over again; And artificial intelligence, for its part, should be able to evaluate the results and prepare for the next experiment. The new system accomplishes these goals, thanks to a general-purpose humanoid robot called Maholo, which is capable of conducting high-precision biological experiments. Maholo to a. is controlled by software Artificial Intelligence that uses a newly designed optimization algorithm To determine which parameters should be changed, and how they should be changed, to improve the differentiation efficiency in the next round of experiments.

In what would have taken human researchers more than two and a half years, robotic systems with artificial intelligence took only 185 days. translate the Go from initial efficiency to 90% in resolution rate of 50% for experiment and improvement work Created by Robot.

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Robotics And AI As Accelerators Of Advances In Regenerative Medicine - Nation World News

Abstract: Organoids bearing human stem cell-derived progenitors enable basic and applied investigation of organogenesis in a wide range of epithelial tissues. During liver organogenesis (LO), E9.5 collectively migrating hepatoblasts (MHs) arise from the E9.0 liver diverticulum (LD) and directly penetrate the surrounding mesoderm (MES) tissue, forming cell strands that link migration, differentiation, and growth. Currently, human pluripotent stem cell (hPSC) organoid protocols model the E10.5 liver bud and forward differentiation, but not the LD or the LD-derived MHs, in spite of their significance. In fact, the transcriptome underlying MHs, the niche that drives their migration, and methods to induce them from hPSC remain key questions. We performed bioinformatics analysis of single cell RNA-seq data, in vivo transplantation, and in vitro hPSC differentiation with organoid formation, microscopy, gene and protein expression, small molecule inhibitor screening of growth, and organoid culture in bioengineered devices to assess tissue tension. Our in depth bioinformatic analysis of early murine LO demonstrates pathway up-regulation of an unexpected wide array of soluble signaling factors, as well as cell cycle, chromatin modification, and metabolic reprogramming, in addition to a widespread cell stress-response. These findings led us hypothesize that the LD and MES tissue form a tissue complex (LD-MESC) that drives MH induction. Using this LD-MESC concept, we designed an in vivo transplant system, as well as a three-step in vitro protocol for inducing hPSC-derived MHs, both of which recapitulate liver growth, morphogenesis, differentiation. We show that Hippo signaling pathway, in agreement with murine MH data, mediates migration and growth of hPSC-MH in vitro. These data substantiate the LD-MESC model developed here, and directly address key challenges facing liver regenerative medicine. Our bioinformatics, in vitro, and in vivo data all support the concept that the LD-MESC initiates LO. This concept can be used to change protocols to emphasize linking of migration, growth, with differentiation. Modeling epithelial collective migration for LO bolsters not only organogenesis studies of alternate endodermal organs, but also in vivo transplantation efforts, and facilitates employing migrating organoids to therapeutically target human tumor migration/metastasis.

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Dynamic changes in the niche and transcription trigger early murine and human pluripotent stem cell-derived liver organogenesis - Newswise

Ms. DuRossbrings more than 25 years' experience to her new position. Prior to joining CSafe, she was the co-founder and CEO of Vineti, an enterprise software platform used to digitize chain of identity and chain of custody requirements for CGT products. Earlier in her career, DuRoss held several prestigious positions including, Chief Business Officer at Navigenics, Chief of Staff for the California Institute for Regenerative Medicine (CIRM), and Co-Founder, Co-Author, and Executive Director of California's $3B stem cell research ballot initiative.

"We are delighted to have Amy leading our CGT team. Her diverse experience in both corporate development, patient advocacy and entrepreneurship is exactly the right mix to drive innovation and superior solutions in this deeply complex supply chain," said CSafeCEO, Patrick Schafer. "We expect to see significant strides forward in this portfolio under Amy's strategic guidance."

"I'm honored to have the opportunity to collaborate with the world-class team at CSafe Global in bringing a new standard of high-quality, high-value supply chain transport to the most exciting innovation area in personalized medicine, cell and gene therapies," Ms. DuRoss said, "CSafe Global's outstanding worldwide service network and proven expertise in robust and actionable analytics to drive supply chain efficiencies will hasten the industrialization of an emergent market that offers critical hope for an increasing number of patients in need."

Ms. DuRossearned her bachelor'sand two master'sdegrees, including her MBA, from Stanford University. She serves on the boards of Biolife Solutions (BLFS), MJH, Americans for Cures, and the ARM Foundation and is a member of the Aspen Institute Global Network.

Media Contact:Lori ConawayGlobal Marketing Communications+1 405.633.2344[emailprotected]

About CSafe Global

CSafe Global provides end-to-end thermal shipping solutions to the pharmaceutical and life science industries worldwide. An industry innovator, CSafe provides AI-enabled lease forecasting to ensure active container availability and real-time shipment visibility for customers to monitor shipments and intervene to preserve a payload when needed. CSafe offers industry-leading maintenance and reuse programs for active and passive containers providing superior product performance and alignment with customer sustainability objectives. With a presence in 150 countries, 24/7 support and 100% container availability, CSafe is well-positioned to be the partner of choice in the cold chain. csafeglobal.com

SOURCE CSafe Global

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CSafe Global Continues Investment in Cell and Gene Therapy Solutions with Addition of New Portfolio President - PR Newswire

The National Institutes of Healths All of Us Research Program aims to recruit 1 million participants to advance biomedical research to benefit all

SAN ANTONIO, July 25, 2022 (GLOBE NEWSWIRE) -- South Texas Blood & Tissue has partnered with the National Institutes of Healths All of Us Research Program, to recruit and engage participants in one of the nations largest and most diverse health information databases.

All of Us aims to enroll at least 1 million participants who reflect the rich diversity of the U.S. Participants can choose to share information about their health history, their environment and they can contribute a blood or saliva sample. This information will help researchers learn how biology, lifestyle and our environment affect our health.

One of the biggest goals of this program is to increase diversity in medical research. Many populations have been left out of research in the past, which means less is known about the health of those groups.

South Texans can join the program by visiting JoinAllofUs.org/SouthTexasBlood. After completing an online portion (including study consents and health history surveys), participants may be asked to visit South Texas Blood & Tissue in San Antonio to have physical measurements taken and give blood and urine samples for the program.

Biological information, health surveys and physical measurements all can help researchers in the new field of precision medicine, which aims to create tailored treatments that are not one-size-fits-all. With this resource, researchers will be able to conduct thousands of studies on health and disease.

All information collected for All of Us will be stored on protected computers, and the NIH will remove participants names and other direct identifiers like Social Security numbers.

Participants may be compensated for their time and travel with a $25 gift card after giving their samples at South Texas Blood & Tissue. Through participating in the program, participants also can receive specific information about their DNA that could help them learn about their unique traits and genetic ancestry, if they want to receive genetic health-related information.

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Anyone 18 years or older living in the United States may participate in this program, regardless of health condition or prior blood donation eligibility.

Joining All of Us is another way for generous donors to improve the health of communities and future generations.

To learn more about All of Us, please call 210-731-5589 or email Research@SouthTexasBlood.org.

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About South Texas Blood & Tissue: South Texas Blood & Tissue (STB&T) is a nonprofit community blood center that provides blood, plasma, platelets, and other blood components to 100 hospitals in 48 South Texas counties. It is the largest blood supplier in our region. In addition, STB&T supports the development of advanced therapies, including those derived from donated human cells and tissues used in research and in new therapies and cures for cancers and degenerative diseases. Through the generous life-legacy gifts of human tissue, STB&T also supports development of tissue allografts for patients in need of reconstructive surgery, repair, or tissue regeneration. STB&T has a 47-year history serving the South Texas community and is part of the BioBridge Global family of nonprofit organizations, which offers services in regenerative medicine and research including blood banking and resource management; cellular therapy; umbilical cord blood collection and storage; donated human tissue recovery and distribution for transplant; and testing of blood and plasma products to help patients in the United States and worldwide. STB&T has seven donor centers in South Texas and conducts hundreds of mobile blood drives each year. STB&T is online at SouthTexasBlood.org.

About BioBridge Global: BioBridge Global (BBG) is a San Antonio-based 501(c)(3) nonprofit regenerative medicine enterprise that offers diverse services through its subsidiaries South Texas Blood & Tissue, QualTex Laboratories, GenCure and The Blood & Tissue Center Foundation. BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue, as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. BBG is committed to saving and enhancing lives through the healing power of human cells and tissue. It enables advances in the field of regenerative medicine by providing access to human cells and tissue, testing services and biomanufacturing and clinical trials support. Learn more at BioBridgeGlobal.org.

All of Us is a registered service mark of the U.S. Department of Health & Human Services (HHS).

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South Texans can participate in massive, national health program to change the future of healthcare - Yahoo Finance

Genome writing company Replay haslaunchedoperations with $55 million in seed financing, mainly from OMX Ventures and KKR.

Replay features next-generation genomic medicine technologies in its portfolio to address the needs of diseases that have large unmet needs. It also aims to create solutions to increase payload capacity and off-the-shelf cell therapies that will improve production volume, speed and consistency, reduce costs and expand opportunities for genome engineering.

Some of the genomic medicine platforms that Replay is working onincludeuCell, a universal, renewable, genomically rewritten iPSC-derived cell source for regenerative medicine and cell therapy; synHSV, a high-payload-capacity HSV vector that can deliver as much as 30 times the AAV payload; and DropSynth, a genome writing platform that enables the low-cost and rapid synthesis of big DNA and libraries of synthetic genes. Its fourth platform, LASR, offers an inference algorithm that can rewrite proteins to achieve optimal functionality.

Replay takes pride in its unique corporate structure, which keeps the therapeutic product development and technology development units separate. The company has set up four synHSV companies to bring key DNA treatments to monogenic disorders affecting the brain, muscle, eye and skin.

"Genomic medicine has the potential to transform the future of clinical therapeutics. Over my three decades of experience working in clinical medicine, academia, and the biopharmaceutical industry, it has become clear that we require a more robust and comprehensive toolkit of molecular genetic platform technologies to solve biology's most complex problems and realize its full therapeutic potential," Adrian Woolfson, B.M., B.Ch., Ph.D., the executive chairman, president and co-founder of Replay, commented in a statement.

Replay was co-founded by Woolfson, Lachlan MacKinnon, and Ron Weiss, Ph.D. MacKinnon is a founding team member at Oxford Science Enterprises and a founding investor in ONI, OMass Therapeutics and Base Genomics, while Weiss is a professor of biological engineering at the Massachusetts Institute of Technology. Before Replay, Woolfson was the executive vice president, head of research and development at Sangamo Therapeutics, and chief medical officer at Nouscom.

"Replay's mission is to create a world-leading company that develops and owns the tools to reprogram biology by writing and delivering big DNA; we believe these capabilities will unlock the largest untapped opportunity in medicine. Replay has tremendous entrepreneurial experience within the Company, as well as a team of seasoned industry players to guide the development of the platform technologies and product companies to bring new treatments to patients," Kugan Sathiyanandarajah, the managing director at KKR who also had a board seat at Replay said.

The other companies that invested in the seed funding are ARTIS Ventures, Lansdowne Partners, SALT, Axial and DeciBio Ventures. KKR is investing through the KKR Health Care Strategic Growth Fund II, which focuses on high-growth health care firms. Replay's headquarters are San Diego, California and London, United Kingdom.

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Replay Launches with $55M In Seed Funding To Author Genomic Medicine - BioSpace

New York, July 21, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Amniotic Products Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type, Application, End User, and Geography" - https://www.reportlinker.com/p06295644/?utm_source=GNW The amniotic membrane and suspension are two products that can be used for treatment.

The amniotic membrane is the innermost layer of the placenta that nourishes and maintains an unborn child. Amniotic fluid is the liquid that surrounds the baby until delivery.Due to the high prevalence of burn wounds, demand for wound care biologics, such as amniotic membranes, has increased significantly.According to the WHO, many burn cases occur in low- and middle-income countries, with over 2-3rd occurring in the WHO African and Southeast Asian areas.

Every year, one million people in India suffer from mild to severe burns (Source: WHO).Other Southeast Asian countries, such as Bangladesh and Nepal, have a high rate of burn cases.

An estimated 173,000 children in Bangladesh yearly suffer from moderate to severe burns. Burn is Nepals second most prevalent injury, accounting for 5% of disability cases.Based on type, the amniotic products market has been bifurcated into amniotic membranes and amniotic suspensions.The amniotic membranes segment is likely to hold the largest share of the market in 2022.

The amniotic membrane segment growth is growing due to increasing research in stem cell and regenerative medicine, high R&D investments, and an increase in the number of surgeries conducted globally.Further, they are commonly employed in the treatment of bacterial keratitis, corneal ulcers, cataract, glaucoma, bullous keratopathy, corneal degeneration, ocular dystrophy, eyelid reconstruction, and other eye surface problems.

The expansion in the worlds senior population increases the number of ophthalmology surgeries, , resulting in a growing need for tissue-based products.Further, PalinGen, Fl?Graft, AmbioDisk, and AmnioFix are examples of commercially available dehydrated amniotic membranes.

In addition, these membranes are widely used in the treatment and management of surgical wounds and incisions, owing to properties such as their ability to maintain a watertight seal, inhibit inflammatory responses, and prevent disease transmissions. Hence, these factors are driving the segment growth.In December 2016, the US passed the 21st Century Cures Act.This new law was passed with the goal of advancing regenerative medicine research and medical innovation.

The Act contains a number of provisions that could impact the development and approval of many products in the coming years.A new "Regenerative Medicine Advanced Therapy" classification and a fast-track approval procedure for innovative regenerative medicine products and therapies have been developed due to this Act.

The passage of this Act could lead to the approval of new regenerative medicine products and therapies in the US and a boost in regenerative medicine research and development.It was designed to promote patient access to electronic health information, advance innovation, and address information blocking practices.

The 21st Century Cures Act was created to help speed up medication development and approval processes, allowing for faster and more efficient delivery of new medical advancements to patients. These requirements are expected to improve interoperability and facilitate electronic health information access, exchange, and use.A few key primary and secondary sources referred to while preparing the report on the prostate cancer nuclear medicine diagnostics market are the World Health Organization (WHO), the Centers for Disease Control and Prevention, and the National Programme for Prevention, Management and Rehabilitation of Burn Injuries.Read the full report: https://www.reportlinker.com/p06295644/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The amniotic products market is expected to grow from US$ - GlobeNewswire

SIRIUS MANAGEMENT CONSULTING

The biopharmaceutical industry is rapidly growing with most pharma companies shifting their focus on increasing the efficacy and safety of biopharmaceutical drugs, thereby allowing them to command high prices for innovative drugs.

Chicago, July 25, 2022 (GLOBE NEWSWIRE) -- According to Ariztons latest research report, the global biopharmaceutical excipients market to grow at a CAGR of 7.56% from 2022 to 2027. The rising demand for biopharmaceuticals is the major factor driving the demand for excipients used in the manufacturing of various biologic drugs. The need for diverse biological treatments is rising as the burden of cancer increases. Both large and small biopharmaceutical businesses continue to look for the molecular causes of cancer and create medications to stop malignant cells. As a result, the biopharma sector is playing a key role in determining many facets of the oncology market.

Cell-based therapy is the fastest-growing segment of regenerative medicine, a field that promises to cure diseases that are not treated by other small molecules or biological drugs. Vaccines are commonly used biologics that are witnessing high demand, especially since the COVID-19 outbreak. Due to the increased production of vaccines, the demand for vaccine-based excipients has increased drastically. In addition, new cell & gene therapies for the treatment of various diseases are also growing. Thus, the need for excipients used in their formulation is likely to grow.

Biopharmaceuticals Excipients Market Report Scope

Report Attributes

Details

MARKET SIZE (2027)

$3.23 Billion

MARKET SIZE (2021)

$2.08 Billion

CAGR (2022-2027)

7.56%

BASE YEAR

2021

FORECAST YEAR

2022-2027

MARKET SEGMENTS

Excipient, Biologics, Scale of Operation

GEOGRAPHIC ANALYSIS

North America, APAC, Europe, Latin America, and MEA

KEY VENDORS

Merck KGAA, BASF SE, Avantor, Evonik Industries, and Roquette

Click Here to Download the Free Sample Report

Emerging Demand for Novel Excipients in Drug Product Development

Novel excipients are playing a crucial role in developing new, improved, and safe drugs for the biopharmaceutical market. Several companies prefer to bring sophisticated and innovative formulations that involve novel excipients. To modernize drug formulation and biopharmaceutical development processes, the FDA launches a testing program to check the safety and suitability of novel inactive ingredients in new drugs and biologics applications. The aim is to encourage sponsors of clinical trials to formulate innovative therapies with those new excipients that the FDA finds acceptable for use under this program.

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Moreover, excipient makers acknowledge that they will be more willing to invest in the production and the characterization of novel excipients if it is possible to gain the FDA review on the benefits of the product outside clinical testing for a new molecular entity. The initiative and ongoing efforts to set international standards for excipient use have the potential to enhance the drug formulation and support modern manufacturing and quality control efforts.

Increasing Need for Outsourcing Biopharmaceutical Excipient Manufacturing

Outsourcing is a common way for pharmaceutical companies to increase their operational efficiencies, expand their geographic footprints, and expand their therapeutic expertise and on-demand services. Outsourcing helps companies to save on resource costs, infrastructure costs, and other overheads. Cost savings remain the main reason for outsourcing multiple features across the industry, but some major pharmaceutical companies have radically changed their outsourcing motives. In the current market, pharmaceutical companies cite improved quality and faster time to market as the main reasons for outsourcing business functions to CROs and CDMOs.

Over the last decade, more and more pharmaceutical and biotechnology companies have turned to complementary metal-oxide semiconductor (CMOs) and contract development and manufacturing company (CDMOs) to help them perform, develop, and manufacture the latest innovations. Outsourcing is a multi-billion-dollar industry today. Most spending is focused on early development, and about two-thirds of annual spending is outsourced.

Key Highlights

In 2021, the monoclonal antibodies segment accounted for the largest share of 45% in the global biopharmaceutical excipients market

The commercial segment dominated the market by contribution largest share of over 73% in 2021.

In 2021, the pharma & biotech companies segment accounted for the larger share of 57.63% in the global biopharmaceutical excipients market.

Key Offerings:

Market Size & Forecast by Volume | 20212027

Market Size & Forecast by Value | 20212027

Market Dynamics Leading trends, growth drivers, restraints, and investment

OpportunitiesMarket Segmentation A detailed analysis by excipient, biologics, scale of operation, end-user, and geography

Competitive Landscape 6 key vendors and 27 other vendors

Market Segmentation

Excipient

Biologics

Monoclonal Antibodies

Vaccines

Others

Scale Of Operation

End-User

Geography

North America

Europe

Germany

France

UK

Switzerland

Italy

Spain

APAC

China

Japan

South Korea

India

Australia

Latin America

Middle East & Africa

Turkey

Saudi Arabia

UAE

South Africa

Competitive Analysis

The global biopharmaceutical excipients market is fragmented, with revenue generated by vendors ranging from emerging mid-sized to established players. Major players are concentrating on strategic licensing, acquisitions, and collaboration agreements with growing players to enter the biopharmaceutical excipients market and to quickly access commercially launched products. Companies are also launching advanced and novel excipient solutions to support pharma drug development. They are focusing more on distribution chains and are providing the required demand for the biopharmaceutical excipients. Players are also focusing on market expansion in existing and newer markets to cater to the needs of an increasing customer base, widening their product portfolios, and boosting their production capabilities that can help in gaining traction from end-users.

Vendors

Merck KGAA

BASF SE

Avantor

Evonik Industries

Roquette Freres

Other Prominent Vendors

Aceto

Angus Chemical

Apothecon

Ashland Global

BioSpectra

BOC Sciences

C.G. Group

Clariant

Colorcon

DFE Pharma

DOW

Eastman Chemical

IMCD N.V.

Innophos

Invitria

JRS Pharma

Kirsch Pharma

Meggle

Novo Nordisk

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Biopharmaceutical Excipients Market to Reach $3.2 Billion by 2027. Rising Demand for Vaccines and Cell & Gene Therapy-based Excipients are the...