Servers – Mindustry Wiki – GitHub Pages

Servers are a large part of Mindustry in that they offer the ability to play the game with other people. There are two main types of servers; dedicated servers and local LAN servers.

Dedicated servers are standalone, headless versions of the game that are focused only on providing a means for people to play Multiplayer. They are usually run on a computer as a separate program rather than in-game, and are operated from the terminal. These are usually stronger than a local LAN server as they have more resources available to them to support more than two or three players, and can be run 24/7. They are also more versatile and powerful in that they have many commands to provide the administrator with more control over it, and they can easily be modded to fit the administrator's needs.

You can connect to one using the "Join Game" button under the "Play" menu. Unlike local LAN servers, you will have to enter the host's IP address and port. Also unlike local LAN servers, once you add a server, it will automatically show up on your server list when you open it, and the game will automatically check the server's status.

To establish a dedicated server, a dedicated Linux or Windows machine is highly recommended.

Unless you have already enabled port forwarding, your dedicated server can only be connected to by clients within your local network. If you want to make your server globally available, read below.

In simplified terms, an IP address is a number that identifies your computer on the internet. You can connect to someone's Mindustry server if you know their IP address. There are two types; a public and a local address.

Most of the time, this is what you should remember; never share your public IP with the public if you're hosting from your home, unless you acknowledge the implications of doing so! Your public IP is tied to your household, and if it falls into the wrong hands, and when put into the wrong hands, can open up your network to vulnerabilities and dangers. Exercise caution, do your research, and use a VPN or webhost if possible.

It is also recommended and that you use a domain name or DNS service to mask your IP for public servers for ease of use, or even better, use a cloud service e.g. Amazon AWS or a dedicated server/VM from a hosting provider such as Linode or DigitalOcean, which is much safer. Do your research, and determine which option best fits your needs.

A local LAN or Steam server is a server that is built into the game, and can be started using the "Host Multiplayer Game" button in the in-game menu. It is meant to be simple and straightforward, for sessions between a few players under a LAN network (aka in your household's WiFi network). It is not really meant for several players, as it takes more and more resources from your device to be able to use it that way; for that you will need a dedicated server mentioned above. It can only run when the game is open, and is immediately terminated when it is closed.

You can connect to one using the "Join Game" button under the "Play" menu. Unlike dedicated servers, your device will automatically find the host device and it will ususally appear in the server list without you having to enter the host's IP address in.

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Stem Cell Therapy Market worth $558 million by 2027 – Exclusive Report by MarketsandMarkets – PR Newswire

CHICAGO, Sept. 2, 2022 /PRNewswire/ --Stem Cell Therapy Marketis projected to reach USD 558 million by 2027 from USD 257 million in 2022, at a CAGR of 16.8% during the forecast period, according to a new report by MarketsandMarkets.Key drivers of the stem cell therapy market include increase in stem cell research funding, expanding number of clinical trials related to stem cell therapies, and growing number of GMP-certified cell therapy production facilities. However, high costs associated with the development of stem cell therapy along with the ethical concerns related to embryonic stem cells are likely to hamper the market growth to a certain extent.

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Browse in-depth TOC on "Stem Cell Therapy Market"155 Tables43 Figures166 Pages

The adipose tissue-derived MSCs segment dominates the cell source market in the stem cell therapy through 2020-2027.

The global stem cell therapy market is segmented into adipose tissue-derived MSCs (mesenchymal stem cells), bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources. Adipose-derived stem cell tissues can be obtained easily and also possess a variety of the regenerative properties similar to other mesenchymal stem cells/tissues. These cells are multipotent and are easy to isolate & harvest; these qualities have collectively rendered the adipose tissue-derived MSCs segment highest revenue in 2021.

In 2021, the musculoskeletal disorders ranked first in terms of revenue in the stem cell therapy market.

Based on therapeutic application, the global stem cell therapy market is segmented into musculoskeletal disorders, wounds & injuries, cardiovascular diseases, surgeries, inflammatory & autoimmune diseases, neurological disorders, and other therapeutic applications. In 2021, the musculoskeletal disorders application segment accounted for the largest share of the stem cell therapy market. Increasing market availability of stem cell-based therapeutic products across major markets and the growing patient preference for effective & early treatment strategies are driving the growth of this segment.

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The Asia Pacific region is the fastest-growing region of the stem cell therapy market in 2021.

The Asia Pacific region is estimated to grow at the highest CAGR in the stem cell therapy market during the forecast period. Japan and South Korea are the key revenue contributors of the Asia Pacific stem cell therapy market. Favorable government support for product approvals and the presence of major players in these countries are anticipated to drive the regional market growth.

The stem cell therapy market is consolidated in nature with prominent players in the stem cell therapy market include Smith+Nephew (UK), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), CORESTEM (South Korea), Pharmicell Co., Ltd. (South Korea), NuVasive, Inc. (US), RTI Surgical (US), AlloSource (US), JCR Pharmaceuticals Co., Ltd. (Japan), Takeda Pharmaceutical Company Limited (Japan), Holostem Terapie Avanzate Srl (Italy), Orthofix (US), Regrow Biosciences Pvt Ltd. (India), and STEMPEUTICS RESEARCH PVT LTD. (India).

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Stem Cell Therapy Market worth $558 million by 2027 - Exclusive Report by MarketsandMarkets - PR Newswire

From optimized stem cell transplants to CAR T cell therapy: Advancing options for cancer, HIV and more – City of Hope

City of Hope recently shared significant news at the 24th Annual AIDS Conference about a patient treated in 2019 whose HIV has been in remission. The man had been living with HIV for 31 years before coming to City of Hope with another grave diagnosisacute myeloid leukemia.One of the best hopes for long-term remission of acute myeloid leukemia (AML) is a stem cell transplant, and City of Hope has one of the nations leading transplant programs, having performed more than 17,000 transplants since 1976. In addition, the institution is at the forefront of using transplants to treat older adults with blood cancers, including increasing efficacy and safety in those over 60 and those with comorbidities, like the then 63-year-old City of Hope patient with HIV. The research was presented by Jana K. Dickter, M.D., City of Hope associate clinical professor in the Division of Infectious Diseases.

City of Hope hematologist Ahmed Aribi, M.D., assistant professor in the Division of Leukemia, prepared the patient for an allogeneic blood stem cell transplant with a chemotherapy-based, reduced-intensity regimen developed for treatment of older patients with blood cancers. Reduced-intensity chemotherapy makes the transplant more tolerable for older patients and reduces the potential for transplant-related complications from the procedure.

Aribi and his team worked with City of Hopes Unrelated Donor BMT Program directed by Monzr M. Al Malki, M.D. to find a donor who was a perfect match for the patient and had the rare genetic mutation, homozygous CCR5 Delta 32, which is found in just 1 to 2% of the general population.

People who have this mutation have a resistance to acquiring HIV. CCR5 is a receptor on CD4+ immune cells, and most strains of HIV use that receptor to enter and attack the immune system. But the CCR5 mutation blocks that pathway, which stops HIV from replicating.

After this successful transplant for both AML and HIV, the patient has been in remission for HIV since stopping ART in March 2021. While this outcome has happened in three other patients, the City of Hope patient was both the oldest to undergo a transplant with HIV and leukemia and go into remission for both. He had also lived with HIV the longest 31 years.

The City of Hope patient is another major advancement. It demonstrates that research and clinical care developed and led at City of Hope are changing the meaning of an HIV diagnosis for patients across the United States and the world, said John Zaia, M.D., director of City of Hopes Center for Gene Therapy, Aaron D. Miller and Edith Miller Chair for Gene Therapy and a leader in HIV research. City of Hope remains at the forefront of clinical research that changes peoples lives for the better.

When I was diagnosed with HIV in 1988, like many others, I thought it was a death sentence. I never thought I would live to see the day that I no longer have HIV. City of Hope made that possible, and I am beyond grateful. The City of Hope patient

The story above is one significant example of several important advances being made at City of Hope in the care of people with HIV. When many centers still treated patients with low-intensity, noncurative treatment approaches for HIV-related lymphoma, City of Hope challenged that paradigm by demonstrating that autologous transplantation could be used to cure patients who would otherwise die.

More recently, City of Hope is leveraging its leadership in CAR T cell therapya groundbreaking treatment currently used to rally the bodys natural defenses against cancer and exploring its potential in tandem with another advance, City of Hopes vaccine for cytomegalovirus (CMV).

In a proof-of-concept study, funded by theCalifornia Institute for Regenerative Medicine, lab models demonstrated that the combination therapy could recognize and eliminate HIV without serious toxicity to cells in the virus host. In cultured human cells, the CAR T cells killed cells tagged with the gp120 protein, and kept killing them, without significant signs of risking damage to healthy cells. In a mouse model for HIV/AIDS, high doses of the dual-action CAR T cells followed by the CMV vaccine were successful in controlling HIV, and even nestled into the bone marrow, indicating potential for treatment to keep working over the long term.

In addition to achieving breakthrough outcomes in cancer and HIV, City of Hope has been recognized as the seventh "Best Hospital" for cancer in the nation according to U.S. News & World Report's 2022-23 Best Hospitals: Specialty Ranking. This marks the first time the cancer treatment center has cracked the top 10 of the U.S. News & World Report annual rankings and the 16th consecutive year it has been distinguished as one of the nation's elite cancer hospitals. It was also rated as high performing in four cancer surgery specialties: lung, colon, prostate and ovarian cancers.

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From optimized stem cell transplants to CAR T cell therapy: Advancing options for cancer, HIV and more - City of Hope

UBC researchers are accelerating the immune cell production pipeline – UBC Faculty of Medicine – UBC Faculty of Medicine

Breakthrough research led by postdoctoral fellow Dr. Yale Michaels (above) reveals how to produce cancer fighting immune cells faster and more efficiently.

Great gains have been made in the field of stem cell research, especially in the last five years with immune cells emerging as a promising treatment for cancer. Despite the progress, the bottleneck of costly and laborious means of production for personalized medicine has remained a barrier. Now, researchers at the Michael Smith Laboratories and the School of Biomedical Engineering have published a breakthrough paper in Science Advances that just might change the game.

The research team, based out of the Zandstra Laboratory, has refined a process to produce cancer fighting immune cells from stem cells faster and more efficiently than previously known methods. With a patent application in the works, this exciting finding could help transform the field of stem cell medicine from an expensive, niche endeavour to something easily scalable and broadly applicable in the clinic.

CAR T therapy, a well-known and successful cancer treatment, involves obtaining immune cells from a patient and genetically modifying them to fight against the patients cancer. Although this type of therapy has an efficacy rate of close to 50 per cent for some cancers, a new batch of medicine needs to be created for each treatment, costing roughly half a million dollars each round.

Because the main cost associated with these treatments is the fact that theyre made individually, a more cost-effective strategy could be figuring out how to manufacture those immune cells in the lab using stem cells, instead of taking them directly from a patient, explains Dr. Yale Michaels, a UBC postdoctoral fellow and first author of the study.

Dr. Yale Michaels

Building on a large body of previous work in the area, Dr. Michaels and team have discovered an efficient way to do exactly that.

Weve figured out the minimal necessary steps to efficiently guide pluripotent stem cells to develop in the dish into immune cells, in particular, T cells, he adds.

T cells are important infection fighters in our body that originate from pluripotent stem cells (PSCs), and until now, their developmental pipeline has been difficult to replicate effectively in the lab. Dr. Michaels and his team discovered that by providing two proteins to the cells during a key window of development improved the efficiency of immune cell production by eighty times.

Their novel method is the fastest known means of producing immune cells in the lab and could mean that hundreds of doses of medicine could be derived from a single cell.

One of the next steps were working on is to scale this up and make it work more efficiently so that we can make enough cells to treat patients. I hope that this publication and the ongoing work in the lab will contribute to future clinical pipelines, says Dr. Michaels.

The improvement of this production pipeline is one step towards solving a variety of human health challenges from cancer to other immune diseases. The success of the research project is the culmination of effort from a diverse team of people within the Zandstra lab and beyond, including engineers, molecular biologists, computer scientist and more.

One of the next steps were working on is to scale this up and make it work more efficiently so that we can make enough cells to treat patients. I hope this ongoing work will contribute to future clinical pipelines. Dr. Yale Michaels

Its been quite rewarding seeing all the fruits of those different knowledge bases coming together, Dr. Michaels reflects. Its the collective work of hundreds or thousands of people, each making important contributions that collectively enable this to succeed. People have made tremendous progress over the last 20 years; this breakthrough is an exciting continuum.

Seeing the potential for findings like these to work towards treating human problems like cancer, immune diseases and transplant rejection is hugely motivating for Dr. Michaels.

Its fascinating to think that one single cell can produce all the cells, with their diverse functions, required to make up an adult human body. And how that happens is an interesting fundamental question about what makes us. The more we learn about how this process unfolds, the better we are able to apply it to treating human disease.

A version of this story originally appeared on the Michael Smith Laboratories website.

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Single-cell Analysis Market worth $6.3 billion by 2026 – Exclusive Report by MarketsandMarkets – GlobeNewswire

Chicago, Sept. 01, 2022 (GLOBE NEWSWIRE) -- According to the new market research report "Single-cell Analysis Market by Cell Type (Human, Animal, Microbial), Product (Consumables, Instrument), Technique (Flow Cytometry, NGS, PCR, Microscopy, MS), Application (Research, Medical), End User (Pharma, Biotech, Hospitals) - Global Forecast to 2026", is projected to reach USD 6.3 billion by 2026 from USD 3.1 billion in 2021, at a CAGR of 15.1% during the forecast period.

Browse and in-depth TOC on "Single-cell Analysis Market" 257 - Tables 57 - Figures 296 Pages

List of Key Players in the Single-cell Analysis Market:

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Single-Cell Analysis Market Dynamics:

Growth in this market is mainly driven by factors such as technological advancements in single-cell analysis products coupled with increasing R&D in the pharmaceutical and biotechnology industries, growing focus on personalized medicine, growth in stem cell research, and the rising prevalence of cancer. However, the high cost of single-cell analysis products is a major factor hampering the growth of the single-cell analysis market.

Based on products, the single-cell analysis market is segmented into consumables and instruments. Consumables accounted for the largest share of 67.4% of the single-cell analysis market in 2020. The large share of this segment can primarily be attributed to the frequent purchase of these products compared to instruments, which are considered a one-time investment. The wide applications of consumables in research and genetic exploration, exosome analysis, and isolation of RNA and DNA are also expected to drive market growth.

Based on cell type, the single-cell analysis market is segmented into human cells, animal cells, and microbial cells. The human cells segment accounted for the largest share of 51.6% of the single-cell analysis market in 2020. The large share of this segment can be attributed to the high utilization of human cells in research laboratories and academic institutes.

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Based on technique, the single-cell analysis market is segmented into flow cytometry, NGS, PCR, microscopy, mass spectrometry, and other techniques. The flow cytometry segment accounted for the largest market share of 29.7% in 2020. The large share of this segment can be attributed to the wide usage of flow cytometry in detecting and measuring the physical and chemical characteristics of a population of cells or particles.

Based on applications, the single-cell analysis market is segmented into research and medical applications. The research applications segment accounted for the largest share of 68.3% of the single-cell analysis market in 2020. Increasing government initiatives in stem cell research and the wide usage of single-cell analysis in cancer research are the major factors driving the growth of the research applications segment.

Based on end users, the single-cell analysis market is segmented into academic & research laboratories, biotechnology & pharmaceutical companies, hospitals & diagnostic laboratories, and cell banks & IVF centers. In 2020, the academic & research laboratories segment accounted for the largest share of the single-cell analysis market. Factors such as growth in funding for life science research and the increasing number of medical colleges and universities are driving the growth of this end-user segment.

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Geographical Growth Scenario:

Based on region, the single-cell analysis market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America accounted for the largest share of 44.9% of the global single-cell analysis market in 2020. This market is expected to reach USD 2,520.2 million by 2026 from an estimated USD 1,282.2 million in 2021, at a CAGR of 14.5%. North Americas prominence in this market is mainly attributed to the presence of key market players, coupled with increasing R&D expenditure and federal funding.

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Mayflower BioVentures to Announce New Cell & Gene Therapy Companies within Months – BioSpace

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A cell and gene therapy accelerator formed by Mayo Clinic, Hibiscus BioVentures and Innoforce is officially up and running, the partners announced Wednesday.

Mayflower BioVentures will identify and launch companies around technologies that address unmet patient needs.

Mayo Clinic hasaccumulated a portfolio of next-generation immune system modulators as well as numerous novel therapeutics in cell and gene therapy. Now Mayo is sharing those discoveries and research capabilities in hopes of reaching patients.

We have the first right to look at the technologies that Mayo considered to be high-value opportunities, Chris Jeffers, CEO of Hibiscus BioTechnology, told BioSpace. Thats an internal designation. And we have the first rights to create companies from those.

It gives Hibiscus the opportunity to incubate and accelerate the companies within Mayflower anywhere between one and two years. Eventually our goal is to graduate those companies to be self-sufficient, independent companies that can obtain their own funding once they leave the accelerator, Jeffers added.

Andrew Danielsen, chair of Mayo Clinic Ventures, told BioSpace that each company will be within Mayflower and owned by the investor syndicate proportionally.

Mayflower has been in the works for at least a year, Jeffers and COO Sia Anaganostou shared, adding that they have been working with Mayo on identifying and developing several companies, which they expect to announce in the coming months.

While unable to provide further details, Jeffers said the areas of focus are anticipated to range from various types of stem cell therapies and gene therapies covering a number of conditions. Some of those technologies are ancillary to cellular therapies, while some are for new pathways to try to escape from traditional immuno-oncology, he said.

Mayflower will be run by the Hibiscus management team.

This is a big push from the Mayo Clinic to really increase its commercialization in this space. Were really proud to be associated with such a fantastic institution with unparalleled clinical expertise, Jeffers said, adding that these factors are a real differentiator.

Danielsen spoke of transitioning research from bench to bedside.

We believe this collaboration can bridge the gap between industry and innovative cell and gene therapy research, enabling emerging startups to navigate the challenges of producing meaningful, novel therapeutics that transform health and medicine, he said in a statement.

Mayos Center for Regenerative Biotherapeutics focuses on advancing regenerative technologies from discovery into early phase clinical studies.

Hibiscus is a venture capital firm focused on building patient-focused companies around new technology and helping to develop those discoveries into commercial drugs and therapies. Hibiscus is comprised of Hibiscus Biotechnology, a venture studio that works to build companies from scratch, and Hibiscus Capital Management, a VC firm that invests in promising early-stage biotech companies.

Innoforce is a partnership-focused biopharma company targeting advanced therapy medicinal products (ATMPs) and biologics. It offers contract development and manufacturing services including GMP manufacturing of plasmid DNA, RNA, viral vector and cell products.

Any revenue generated by Mayflower will go toward Mayo Clinics patient care, education and research.

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Mayflower BioVentures to Announce New Cell & Gene Therapy Companies within Months - BioSpace

Effect of sorafenib maintenance on Epstein-Barr virus and cytomegalovirus infections in patients with FLT3-ITD AML undergoing allogeneic hematopoietic…

Study population

A total of 202 patients with FLT3-ITD AML (sorafenib, n=100; control, n=102) were recruited from June 20, 2015, to July 21, 2018. The median age was 35 (range: 1860) years, with 102 males and 100 females. Patient characteristics are summarized in Table 1. Baseline factors were well balanced between the two groups. With a median of 18 days after sorafenib initiation, 59 of 100 patients required dose modifications due to adverse events, including 42 dose reductions, 12 dose interruptions, and 5 discontinuations. The median follow-up was 36.8 (range, 2.567.1) months post-transplantation.

EBV-DNAemia occurred in 22 (22.0%) patients in the sorafenib group and 23 (22.5%) patients in the control group (P=0.925). Four patients developed EBV-DNAemia 1 year after allo-HSCT, including two in the sorafenib group and two in the control group. The 1-year cumulative incidence of EBV-DNAemia was 22.0% (95% CI: 14.430.6%) and 22.5% (15.031.1%) in the sorafenib and control groups (HR=0.946, 95% CI: 0.5271.698, P=0.931). The 3-year cumulative incidence of EBV-DNAemia was 24.0% (16.132.8%) and 24.5% (16.633.2%) in the two groups, respectively (HR=0.930, 95% CI: 0.5311.629, P=0.937) (Fig. 2A).

Cumulative incidences of EBV-DNAemia (A), EBV-associated disease (B), CMV-DNAemia (C), and CMV-associated disease (D) in the sorafenib and control groups

Five patients developed EBV-associated diseases in the sorafenib group including 4 EBV-post-transplant lymphoproliferative diseases (PTLD) and 1 EBV-pneumonia, and 6 patients in the control group including 3 EBV-PTLD, 2 EBV-enteritis, and 1 EBV-encephalitis. Two patients developed EBV-associated diseases 1 year after allo-HSCT, including one in the sorafenib group and one in the control group. The 1-year cumulative incidence of EBV-associated diseases was 4.0% (95% CI: 1.39.2%) and 4.9% (1.810.4%) in the sorafenib and control groups (HR=0.745, 95% CI: 0.2002.779, P=0.744). The 3-year cumulative incidence of EBV-associated diseases was 5.0% (1.810.6%) and 5.9% (2.411.6%) in the two groups, respectively (HR=0.745, 95% CI: 0.2272.448, P=0.771) (Fig. 2B).

Only one patient in the control group received EBV-CTL for EBV-PTLD, and none of the patients received DLI for EBV infections. No patients in the sorafenib group died of EBV-associated diseases, and one patient in the control group died of EBV-PTLD. The 3-year cumulative mortality of EBV-associated diseases was 0.0% (95% CI: 0.00.0%) and 1.0% (0.14.8%) in the sorafenib and control groups (HR=0.016, 95% CI: 0.0150458.5, P=0.322).

CMV-DNAemia occurred in 54 (54.0%) patients in the sorafenib group and 53 (52.0%) patients in the control group (P=0.772). Seven patients developed CMV-DNAemia 100 days after allo-HSCT, including four in the sorafenib group and three in the control group. The initial and maximum CMV loads in the sorafenib group were 2070 (range, 51233,600) copies/ml and 2750 (range, 550175,000) copies/ml, compared with 1790 (range, 55012,300) copies/ml and 3120 (range, 57070,500) copies/ml in the control group (P=0.612; P=0.882). The duration of CMV-DNAemia was 16 (range, 450) days and 17 (range, 477) days in the sorafenib and control groups (P=0.904). The 1-year cumulative incidence of CMV-DNAemia was 54.0% (95% CI: 43.763.2%) and 52.0% (41.861.2%) in the sorafenib and control groups (HR=0.974, 95% CI: 0.6671.423, P=0.911). The 3-year cumulative incidence of CMV-DNAemia was 56.0% (45.665.1%) and 52.9% (42.762.1%) in the two groups, respectively (HR=0.991, 95% CI: 0.6821.441, P=0.997) (Fig. 2C).

Up to the last follow-up, 8 patients developed CMV-associated diseases in the sorafenib group including 4 CMV-pneumonia, 3 CMV-enteritis, and 1 CMV-retinitis, and 9 patients in the control group including 6 CMV-enteritis, 2 CMV-pneumonia, and 1 CMV-encephalitis. Six patients developed CMV-associated diseases 100 days after allo-HSCT, including three in the sorafenib group and three in the control group. The 1-year cumulative incidence of CMV-associated diseases was 8.0% (95% CI: 3.714.4%) and 7.8% (3.714.1%) in the sorafenib and control groups (HR=0.949, 95% CI: 0.3562.531, P=0.984). The 3-year cumulative incidence of CMV-associated diseases was 8.0% (3.714.4%) and 8.8% (4.315.3%) in the two groups, respectively (HR=0.830, 95% CI: 0.3202.155, P=0.826) (Fig. 2D).

Seven patients (four in the sorafenib group and three in the control group) received CMV-CTL for CMV infections, and none of the patients received DLI for CMV infections. Two patients in the sorafenib group and two in the control group died of CMV-associated diseases. The 3-year cumulative mortality of CMV-associated diseases was 2.0% (95% CI: 0.46.4%) and 2.0% (0.46.3%) in the sorafenib and control groups (HR=0.955, 95% CI: 0.1346.786, P=0.980).

Univariable and multivariable analyses of the risk factors for EBV and CMV infections post-transplantation are shown in Tables 2 and 3. All patients undergoing HID/MUD transplants received ATG as GVHD prophylaxis, and none of patients undergoing MSD transplants received ATG as GVHD prophylaxis. Considering there was collinearity between transplant modality (HID/MUD vs MSD) and ATG use in the conditioning (ATG vs no ATG), we only included ATG use in the analysis of risk factors for EBV/CMV infections. On multivariate analysis, ATG use was the only risk factor for EBV-DNAemia (HR=4.408, 95% CI: 1.9679.878, P<0.001) and EBV-associated diseases (HR =3.235, 95% CI: 1.0789.711, P=0.036), respectively. ATG use (HR =2.797, 95% CI: 1.7834.387, P<0.001) and aGVHD (HR =1.641, 95% CI: 1.0672.522, P=0.024) were the risk factors for CMV-DNAemia; aGVHD (HR =3.179, 95% CI: 1.1758.601, P=0.023) was the only risk factor for CMV-associated diseases. In contrast, age, sex, EBV and CMV serological status, CR status at transplantation, sorafenib use pre-transplantation and post-transplantation, and cGVHD did not show any significant influence on the risk of EBV and CMV infections.

Immune reconstitution was similar with respect to the counts of T lymphocyte subsets (CD3+, CD3+CD4+, CD3+CD8+), B lymphocytes (CD19+), and NK cells (CD3-CD56+) at 1, 3, 6, 9, and 12 months after allo-HSCT between the sorafenib and control groups (all P >0.05) (Table 4).

At the date of statistical analysis, 142 patients survived and 60 died, of whom 21 were in the sorafenib group and 39 were in the control group. Causes of death were leukemia relapse (n=31; 7 in the sorafenib group and 24 in the control group), infections (n=18; 10 in the sorafenib group and 8 in the control group), GVHD (n=8; 3 in the sorafenib group and 5 in the control group), EBV-PTLD (n=1; control group), thrombotic microangiopathy (n=1; control group), and acute left heart failure (n=1; sorafenib group). The 3-year cumulative incidence of relapse was 13.0% (95% CI: 7.320.4%) and 34.8% (25.544.2%) in the sorafenib and control groups, respectively (HR=0.306, 95% CI: 0.1620.579, P<0.001) (Fig. 3A). The 3-year NRM was 11.1% (95% CI: 5.918.3%) and 12.7% (7.120.0%) in the two groups (HR=0.689, 95% CI: 0.3081.540, P=0.656) (Fig. 3B). The 3-year OS was 79.0% (95% CI: 69.685.8%) and 61.4% (51.170.1%; HR=0.481, 95% CI: 0.2830.818, P=0.005), LFS was 75.9% (95% CI: 66.283.1%) and 52.5% (42.261.7%; HR=0.410, 95% CI: 0.2510.670, P<0.001), and GRFS was 65.8% (95% CI: 55.674.3%) and 46.6% (36.656.0%; HR=0.531, 95% CI: 0.3450.816, P=0.003), respectively, in the sorafenib and control groups (Fig. 3CE).

Cumulative incidences of leukemia relapse (A), non-relapse mortality (B), overall survival (C), leukemia-free survival (D), and GVHD-free/relapse-free survival (E) in the sorafenib and control groups. *P < 0.05

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Effect of sorafenib maintenance on Epstein-Barr virus and cytomegalovirus infections in patients with FLT3-ITD AML undergoing allogeneic hematopoietic...

Applied StemCell expands manufacturing facility to support cell and gene therapies – BioPharma-Reporter.com

The Milpitas, California cell and gene therapy CRO/CDMO, whose focus is on supporting the research community and biotechnology industry in developing and manufacturing cell and gene products, has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/QA space.

The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow ASCs team of experts to work simultaneously on multiple manufacturing projects such as iPSC generation, gene editing, differentiation, and cell bank manufacturing for safe and efficacious therapeutic products.

ASC estimates it will be able to take on four times as many projects once the expansion is complete early next year. Work on construction will begin within the next month and the company has already started the process to hire new staff.

President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. said, We are committed to becoming a CDMO leader to support regenerative medicine and cell/gene therapy development and manufacturing. We aim to expand our bio-manufacturing capacity to meet the fast-growing demand in the cell and gene therapy industry.

"Our unique platform of GMP-grade allogeneic iPSC and TARGATTgene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.

ASC has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB). It has a Quality Management System (ISO 13485 certified) and established cGMP-compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation, and cell product manufacturing.

With over 13 years of gene-editing and stem cell expertise, ASC offers customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATT) technologies, facilitate site-specific, large cargo (up to 20kb) transgene integration and the development of allogenic cell products.

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Applied StemCell expands manufacturing facility to support cell and gene therapies - BioPharma-Reporter.com

This Week at FDA: ACIP signs off on bivalent boosters – Regulatory Focus

| 02 September 2022 | By Michael Mezher Welcome to another installment of This Week at FDA, your weekly source for updates big and small on FDA, drug and medical device regulation, and what were reading from around the web. The biggest news out of FDA this week was the agencys decision to authorize bivalent COVID-19 vaccine boosters from Pfizer-BioNTech and Moderna. On Thursday, a key Centers for Disease Control and Prevention (CDC) panel voted 13-1 in support of both modified boosters. On Wednesday, FDA amended the emergency use authorizations (EUAs) for both the Pfizer and Moderna vaccines to authorize the vaccine makers new bivalent compositions targeting the Omicron BA.4/5 subvariants and the original SARS-CoV-2 strain. The bivalent Pfizer-BioNTech booster is authorized for use in individuals 12 and older, while Modernas bivalent shot is authorized for adults 18 and older. FDA noted that the primary series will retain the original monovalent formula, though the monovalent boosters will no longer be offered to the age groups eligible for the bivalent vaccines. The following day, the CDCs Advisory Committee on Immunization Practices (ACIP) voted nearly unanimously to recommend the modified boosters, Stat reports. The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants, said CDC Director Rochelle Walensky. She noted that the agency expects to recommend bivalent boosters for other pediatric age groups in the coming weeks. Pfizer has said it plans to submit a request for its Omicron-adapted bivalent vaccine for the 5-11 age group early next month. In other regulatory news, Bloomberg Law reports that FDAs proposed rule to harmonize its regulations on human subject protection and institutional review boards with the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, has gone through Office of Management and Budget (OMB) review, clearing the proposal for publication. We also learned from Endpoints and the Los Angeles Times that a federal judge in California ruled against FDA in its case against the California Stem Cell Treatment Center (CSCTC). The ruling could upend FDAs efforts to reign in stem cell clinics offering unproven treatments. FDA ended a multi-year period of enforcement discretion for regenerative medicine products last year and has since stepped up efforts to bring such entities in compliance with its regulations. It has written dozens of untitled letters to companies offering various cellular-derived products that the agency feels should be subject to a biologics license application. Drugs & Biologics On Thursday, FDA announced a new pre-consortium partnership with the Critical Path Institute (C-Path) aimed at facilitating the development of drugs for patients with lysosomal diseases. The partnership will involve academic institutions, drugmakers and patient groups, and the effort falls under FDAs Accelerating Rare disease Cures (ARC) program. FDA also announced the approval of Sanofis Xenpozyme (olipudase alfa) as the first approved treatment for acid sphingomyelinase deficiency (ASMD) in the US. ASMD has a debilitating effect on peoples lives and there is a critical need to increase treatment options for patients who suffer from this rare disease, said Christine Nguyen, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDAs Center for Drug Evaluation and Research. The drug is an enzyme replacement therapy that reduces the amount of sphingomyelin accumulation in the liver, spleen and lungs. It received fast track, breakthrough therapy, priority review and orphan designation, and FDA awarded the company a valuable rare pediatric disease priority review voucher with the approval. Additionally, the agency posted new data on the impact of its Generic Drug User Fee Amendments (GDUFA II) science and research efforts in FY2021.

For generic products in development, FDA noted that the number of pre-ANDA meetings impacted by the agencys research increased from 92 meetings in FY2020 to 113 meetings in FY2021. Similarly, the number of controlled correspondences impacted by its research rose from 291 to 457 in the same time period. Some measures decreased; FDA said the number of product-specific guidances (PSGs) impacted by its research declined from 86 in FY2020 to 40 in FY2021. For products with an ANDA submission, most of the metrics declined or stayed about the same from FY2020 to FY2021. Medtech This week, the Center for Devices and Radiological Health identified several recalls as Class I recalls, the most serious type, including recalls for Integras CereLink ICP Monitor, certain Philips Respironics BiPAP Machines, Intera Oncologys Intera 3000 Hepatic Artery Infusion Pump and Hamilton Medical AGs Hamilton-C6 Intensive Care Ventilator. We also learned this week that a Philips Respironics will pay $24 million to address alleged false claims for its respiratory products, according to Reuters.

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Recombinant Cell Culture Supplements Market to Witness a CAGR of 12.5% during Forecast Period | BlueWeave Consulting – GlobeNewswire

New Delhi, Aug. 31, 2022 (GLOBE NEWSWIRE) -- Global Recombinant Cell Culture Supplements Market is growing at a high CAGR because of the rising investments in life sciences research and development. The increased preference and use of animal-free supplements is also driving the global recombinant cell culture supplements market.

A recent study conducted by the strategic consulting and market research firm, BlueWeave Consulting, revealed that the Global Recombinant Cell Culture Supplements Market was worth USD 309.3 million in the year 2021. The market is projected to grow at a CAGR of 12.5%, earning revenues of around USD 702.5 million by 2028. The global recombinant cell culture supplements market is booming because of the increasing investment in drug research and development coupled with the rising demand for cell culture supplements. Moreover, the advantages of animal-free biotherapeutics and biopharmaceuticals over traditional animal-derived supplements are driving the growth of the global recombinant cell culture supplements market during the forecast period 2022-2028.

Rising Demand for Recombinant Cell Culture Supplements to Drive the Market Growth

Over the years, the demand for recombinant cell culture supplements has risen. This is because cell culture is an integral part of drug research and development, and manufacturing. With the increasing population, humanity is seeing the advent of novel viruses, fungi, and bacteria, causing diseases. To save humanity against acute and chronic, infectious and non-infectious, communicable and non-communicable diseases, it is essential to invent and produce a variety of recombinant proteins, vaccines, diagnostic reagents, advanced therapies, and biotherapeutics and biopharmaceuticals. They are produced using prokaryotic (bacteria, yeast cells) and eukaryotic (mammalian cells, transgenic plants) expression host systems in large-scale settings. These therapeutic and prophylactic recombinant proteins are produced by continuous upstream processing, continuous chromatography, integrated continuous bioprocessing, etc., to achieve high quality and quantity of proteins. The increased production to fulfill the high demand is expected to bolster the growth of the market in the forecast period.

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Global Recombinant Cell Culture Supplements Market - By Product

Based on products, the global recombinant cell culture supplements market is segmented into recombinant growth factors, recombinant insulin, recombinant albumin, recombinant transferrin, recombinant trypsin, recombinant aprotinin, recombinant lysozyme, and others. Amidst the segmentation, the recombinant albumin (rAlbumin) segment is expected to grow with the highest CAGR during the forecast period 2022-2028 because albumin is a widely used nutrient in all cells cultures; for example, the production of monoclonal antibodies.

Global Recombinant Cell Culture Supplements Market - Regional Insights

Based on regions, the global recombinant cell culture supplements market has been segmented into five categories- North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Amidst the segmentation, North America dominated the global Recombinant Cell Culture Supplements market share in 2021 due to the availability of appropriate technology and sufficient funding. On the other hand, Europe is estimated to grow at the highest rate due to a large number of recombinant cell culture supplement products and manufacturing units, biopharmaceutical organizations and research institutes, and increased government funds for cell science research organizations.

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Impact of COVID-19 on Global Recombinant Cell Culture Supplements Market

As a result of the COVID-19 pandemic, worldwide lockdowns were imposed, and manufacturing and operations were seriously affected. This hampered the ongoing research and clinical development of various biopharmaceutical products. To prevent infection from the notorious SARS-CoV-2, research grants were given out for the research and development of Covid vaccines. In the later phases of the pandemic, the governments emphasis shifted on building a robust supply chain for the transportation of Covid test kits, diagnostics, drugs, vaccines, and recombinant supplements. Due to the recommencement of sales for research purposes, the recombinant cell culture supplement-producing firms were able to maintain their financial position.

Competitive Landscape

Thermo Fisher Scientific Inc., Merck KGaA, Becton, Dickinson and Company, Hi-Media Laboratories, Sartorius AG, InVitro, SeraCare Life Sciences Inc., GE Healthcare, Novozymes A/S, Advanced Biotechnologies Inc., Lonza, STEMCELL Technologies Inc., PeproTech Inc., Sino Biological Inc., FUJIFILM Irvine Scientific, Evercyte GmbH, Kingfisher Biotech Inc. In March 2022, Thermo Fisher Scientific acquired PeproTech, a company that specializes in the development and manufacturing of recombinant proteins, for USD 1.85 billion. The companies aim to expand their business by setting up more manufacturing plants to gain a significant market share. For example, in May 2022, FUJIFILM Irvine Scientific built a new bioprocessing center in China. They also constructed a new cell culture media manufacturing facility in the Netherlands in June 2019.

Dont miss the business opportunity in the Global Recombinant Cell Culture Supplements Market. Consult our analysts to gain crucial insights and facilitate your business growth.

The in-depth analysis of the report provides information about growth potential, upcoming trends, and statistics of the global recombinant cell culture supplements market. It also highlights the factors driving forecasts of total market size. The report promises to provide recent technology trends in the global recombinant cell culture supplements market and industry insights to help decision-makers make sound strategic decisions. Furthermore, the report also analyzes the growth drivers, challenges, and competitive dynamics of the market.

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Recombinant Cell Culture Supplements Market to Witness a CAGR of 12.5% during Forecast Period | BlueWeave Consulting - GlobeNewswire