Monthly Archives: March 2017

JNU admission 2017: Applications released for MSc, MTech Biotechnology courses, check here – The Indian Express

Posted: March 24, 2017 at 3:43 pm

By: Express Web Desk | New Delhi | Updated: March 24, 2017 12:45 pm CEEB 2017: The details of the course under each university is provided in three prospectus available on the official website

CEEB 2017: The Jawaharlal Nehru University (JNU), Delhi has announced that it will hold The Combined Entrance Examination (CEEB) 2017 for MSc in Biology, MSc in Agricultural Biotechnology and MTech in Biotechnology will be held on May 19, 2017. Candidates who are interested in the courses can apply online from JNUs official website.

The exam is being held by JNU on behalf of 14 universities that offer Agricultural Biotechnology, 32 that offer Biotechnology and six institutes offering MTech in Biotechnology. The details of the course under each university is provided in three prospectus available on the official website along with the fees to be paid at the time of admission. Candidates can also check the eligibility requirements for each college provided in the prospectus.

Steps to apply for CEEB 2017:

Go to the official website for JNU (jnu.ac.in).

Click on the admissions tab on the home page.

Click on the notification Combined Entrance Examination for Biotechnology Programmes [ CEEB ] Prospectus 2017-18 and read the prospectus provided for each course. Make sure to check all details before proceeding.

On the admissions page, click on Apply online and follow the link for CEEB.

Read the instructions carefully and click on I Accept Apply Online.

Fill in the details in the fields provided and click on Register.

Download a copy of the application form for further reference.

For more stories on CEEB 2017, click here

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JNU admission 2017: Applications released for MSc, MTech Biotechnology courses, check here - The Indian Express

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Field of biotechnology is ever expanding and evolving – BSI bureau (press release)

Posted: March 24, 2017 at 3:43 pm

Dr Kalpana Joshi shares her thoughts with BioSpectrum on current biotech education and the academia-industry gap

Dr Kalpana Joshi is Professor and Head of the Department of Biotechnology at Sinhgad College of Engineering (SCOE). The institute is affiliated to Savitribai Phule Pune University (SPPU) and recognised by All India Council for Technical Education (AICTE), New Delhi. Recently, SCOE has received NAAC "A" Grade. BTech Biotechnology course run by the department is first AICTE approved course in SPPU. Dr Joshi completed her doctorate in molecular biology from National Chemical Laboratory. She headed in-vitro biology group at Pharma R and D, besides giving consultancy to pharma companies like Glenmark, Matrix, Hyderabad and Orchids, Chennai. The SCOE department has a team of faculty with expertise in fermentation engineering, biochemical engineering, pharma biotechnology, biochemistry, analytical chemistry and microbiology. Faculty is active in fetching grants for research, patents and publications. Dr Joshi shares her thoughts with BioSpectrum on current biotech education and the academia-industry gap

Do you think biotech schools are teaching what industry needs?

Field of biotechnology is ever expanding and evolving. Pharma companies have diversified into production and business of biotherapeutics, vaccines and immunologicals, and molecular diagnostics. Industries such as agri-biotech, dairy biotech, food biotech are coming up and have specific requirement of skilled manpower. I feel giving hard core fundamental knowledge of the subjects and skill development are essential to meet industry requirement.

Specific requirements of industry when it comes to biotech education?

Industry requires experienced and trained manpower. There is no time for training in companies. I remember my former boss used to tell me Kalpana this is not university for training. Take someone who would work from the next day.' Biotech schools need to develop necessary laboratory skills and strong basics.

Where is the gap according to you?

As a manager in drug discovery R&D of top pharma company, I used to interview candidates from renowned biotech schools in India. Major observation was students lacked practical skills and basic knowledge of fundamental subjects like microbiology, immunology, molecular biology, biochemistry etc. We at SCOE decided to focus on developing strong knowledge and skills in three pillars of biotechnology namely microbiology, biochemistry, and molecular biology with blend of engineering fundamentals like mass transfer, heat transfer, unit operations, plant design and process development. We have created excellent facilities so that students get to handle top brand equipment like PCR, HPLC, Lyophiliser, fermenters, microfiltrations and develop practical skills in molecular biology, animal tissue culture and data analysis softwares. Gap is at many places. I can give examples. Students use graph papers to plot graphs. We need to train them to use Excel to analyse data and plot graphs using softwares like Prism and SPSS normally used by industries

What do you do to bridge the skill gap if it exists?

At Sinhgad Institutes, we have state-of-the-art laboratories where students are trained for developing practical skills in microbiology, enzymology, molecular biology, fermentations and reaction engineering. We also teach them computation and statistics. Students work on projects and develop skills in at least one technique such as PCR, HPLC or cell culture. They are trained to be analytical, logical and develop problem solving capacity. Students are encouraged to do industry internships and projects in collaboration with companies and national laboratories.

What has been the investment in student training?

We have invested in infrastructure, facilities, equipment and faculty. Faculty members are PhD/ MTechs from renowned institutes like NCL, IITs, ICTs with industry exposure. If faculty does not know what is happening in the industry then it is difficult to percolate it to students. We ensure that faculty gets exposure to industry and maintain interactions with industry experts

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Field of biotechnology is ever expanding and evolving - BSI bureau (press release)

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Karnataka’s biotechnology finishing school programme, five years on – BSI bureau (press release)

Posted: March 24, 2017 at 3:43 pm

Dr S Balasubramanya, BTFS Coordinator and Dr Mittur N Jagadish, Head-BioTech Facilitation Cell, KBITS, Government of Karnataka

Karnataka state has remained one of the major investment destinations in the biotech industry. Currently, the State of Karnataka contributes around 35 per cent of the Indian biotechnology sector. The state government has established Biotechnology Bio-Innovation Centre at Bengaluru Helix.

Theme-based biotech parks are at various stages of implementation in Bidar, Dharwad, Mangaluru and Mysuru. The state has already in place, multi-sector start-up policy with various industry specific incentives and ease of doing business measures to stimulate growth of industry in Karnataka.

Life Sciences Sector Skill Development Council (LSSSDC) has estimated life sciences industry which includes biotechnology industry to employ 1.5-1.6 million people by 2020. The sector is expected to see a possible supply gap upwards of 0.3-0.4 million, with the highest gap in the manufacturing segment.

The majority of full-time employees are distributed between marketing and manufacturing, and a limited number in R&D and other functions. Approximately, 40 per cent job roles are clustered at entry/junior level; 35 per cent at mid-level and 20 per cent at senior levels in the industry.

The junior and entry level positions that make up 40 per cent of the job roles requires attributes such as technical proficiency in laboratories, subject knowledge (basic and superior), high learning aptitude and thinking and questioning ability as key skills. Need is also felt for skill and capability building in Quality, IP and Regulatory aspects. Biotechnology industry in India is growing conservatively at 10 - 15 per cent and is said to be adding 15 to 20 per cent workforce to existing 50,000 jobs. The entry level jobs are 5 per cent of the 15 - 20 per cent workforce added each year.

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Karnataka's biotechnology finishing school programme, five years on - BSI bureau (press release)

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MVIT organises three-day national seminar on Biotechnology – Times of India

Posted: March 24, 2017 at 3:43 pm

BENGALURU: For all Bioscience graduates pursuing BE, BTech, BSc, MSc, MTech and PhD courses, there is good news for their career. The department of Biotechnology at Sir M Visvesvaraya Institute of Tecnology (MVIT) is organising a three day national seminar on Entrepreneurial Opportunities in Biotechnology from March 23 - 25 at its campus. The seminar that is also open to inquisitive parents, energetic alumni, enthusiastic faculty and industry experts is expected to alleviate the many concerns of graduates and their parents regarding their future prospects and career development. HG Nagendra, professor and head of the Biotechnology department, said: "The focus of education is to not only train the students in curriculum defined skillsets but also to guide them towards realising their higher aspirations." The seminar includes invited plenary talks by subject experts, panel discussions, industry-academia interactive sessions, poster sessions, project idea presentations, several stalls and displays. Cash awards will be awarded to those with best presentations and networking at the seminar.

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MVIT organises three-day national seminar on Biotechnology - Times of India

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The stem cell procedure that may change the sports medicine field in 2017 5 observations – Becker’s Orthopedic & Spine

Posted: March 24, 2017 at 3:42 pm

Physicians, healthcare professionals and members of the MLB community will keep a close eye on Red Sox pitcher Andrew Pomeranz's recovery from a potentially career-saving stem cell procedure, according to The Boston Globe.

Here are five things to know:

1. Steve Yoon, MD, of the Los Angeles-based Kerlan-Jobe Orthopaedic Clinic extracted bone marrow from Mr. Pomeranz's hip bone and back and injected it into his flexor tendon.

2. Mr. Pomeranz was motivated to undergo the procedure after fellow pitchers Garrett Richards and Andrew Heaney opted for the treatment instead of undergoing Tommy John Surgery to treat the partial tears in their ulnar collateral ligaments.

3. Lyle Cain, MD, of Birmingham, Ala.-based Andrews Sports Medicine & Orthopedic Center said, "Stem cells are a way to try to deliver the chemicals to cells and the chemical attractive factors to that area to allow the body to heal that tissue. That's what PRP was used for as well. Stem cells have more promise because not only do they have the chemicals that platelet-rich plasma has, but you're also putting some of the healing cells themselves in that area."

4. Pitcher Bartolo Colon was the first baseball player known to receive stem cell treatment when he received injections in his injured rotator cuff and elbow in the Dominican Republic in 2010. The 43-year-old pitcher's career was resurrected following the operation, partially prompting the method's increased popularity.

5. If Mr. Pomeranz has a successful 2017 season, the number of players undergoing stem cell procedures may rise.

More articles on sports medicine:

Nearly-paralyzed ex-NFL player promoting neck injury research 4 takeaways

Does single-sport focus increase athlete injuries? 5 things to know

Knee application segment leads global sports medicine market 8 observations

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The stem cell procedure that may change the sports medicine field in 2017 5 observations - Becker's Orthopedic & Spine

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Peptide targeting senescent cells restores stamina, fur, and kidney function in old mice – Medical Xpress

Posted: March 24, 2017 at 3:42 pm

March 23, 2017 Two fast-aging mice. The mouse on the left was treated with a FOXO4 peptide, which targets senescent cells and leads to hair regrowth in ten days. The mouse on the right was not treated with the peptide. Credit: Peter L.J. de Keizer

Regular infusions of a peptide that can selectively seek out and destroy broken-down cells that hamper proper tissue renewal, called senescent cells, showed evidence of improving healthspan in naturally-aged mice and mice genetically engineered to rapidly age. The proof-of-concept study, published March 23 in Cell, found that an anti-senescent cell therapy could reverse age-related loss of fur, poor kidney function, and frailty. It is currently being tested whether the approach also extends lifespan, and human safety studies are being planned.

The peptide took over four years of trial and error to develop and builds on nearly a decade of research investigating vulnerabilities in senescent cells as a therapeutic option to combat some aspects of aging (Trends in Molecular Medicine, 10.1016/j.molmed.2016.11.006). It works by blocking the ability of a protein implicated in senescence, FOXO4, to tell another protein, p53, not to cause the cell to self-destruct. By interfering with the FOXO4-p53 crosstalk, the peptide causes senescent cells to go through apoptosis, or cell suicide.

"Only in senescent cells does this peptide cause cell death," says senior author Peter de Keizer, a researcher of aging at Erasmus University Medical Center in the Netherlands. "We treated mice for over 10 months, giving them infusions of the peptide three times a week, and we didn't see any obvious side effects. FOXO4 is barely expressed in non-senescent cells, so that makes the peptide interesting as the FOXO4-p53 interaction is especially relevant to senescent cells, but not normal cells."

Results appeared at different times over the course of treatment. Fast-aging mice with patches of missing fur began to recover their coats after 10 days. After about three weeks, fitness benefits began to show, with older mice running double the distance of their counterparts who did not receive the peptide. A month after treatment, aged mice showed an increase in markers indicating healthy kidney function.

Senescent cell therapy is one of several strategies being tested in mice aimed at reversing aging or lengthening healthspan. In 2015, the Valter Longo laboratory at the University of Southern California reported that mice on a calorie-restricted diet that mimics fasting benefited from a longer life, a reduction in inflammatory disease, and improved memory (Cell Metabolism, 10.1016/j.cmet.2015.05.012). And last December, Juan Carlos Izpisua Belmonte at the Salk Institute of Biological Science and colleagues made headlines with their discovery that cellular reprogramming of epigenetic marks could extend lifespan and improve health in fast-aging mice (Cell, 10.1016/j.cell.2016.11.052).

"This wave of research on how we can fight aging is complementary, and not in competition," says de Keizer. "The common thread I see for the future of anti-aging research is that there are three fronts in which we can improve: The prevention of cellular damage and senescence, safe therapeutic removal of senescent cells, to stimulate stem cellsno matter the strategyto improve tissue regeneration once senescence is removed."

de Keizer aims to start a company based on these findings, but in the short term, he and his group want to show that their peptide is non-toxic in humans with no unforeseen side effects. They plan to offer a safety clinical trial in people with Glioblastoma multiforme, an aggressive brain tumor, which also shows high levels of the biomarkers needed for this FOXO4 peptide to be effective.

Explore further: Anti-aging therapies targeting senescent cells: Facts and fiction

More information: Cell, Baar et al.: "Targeted Apoptosis of Senescent Cells Restores Tissue Homeostasis in Response to Chemotoxicity and Aging" http://www.cell.com/cell/fulltext/S0092-8674(17)30246-5 DOI: 10.1016/j.cell.2017.02.031

Sebastian Brandhorst et al. A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan, Cell Metabolism (2015). DOI: 10.1016/j.cmet.2015.05.012

Alejandro Ocampo et al. In Vivo Amelioration of Age-Associated Hallmarks by Partial Reprogramming, Cell (2016). DOI: 10.1016/j.cell.2016.11.052

Journal reference: Cell Cell Metabolism

Provided by: Cell Press

It's an exciting time to be an elderly mouse. Researchers believe that by removing senescent cells (cells with a persistent damage response), which naturally accumulate with age, senior rodents can regrow hair, run faster, ...

Most cells can divide only a limited number of times and eventually undergo permanent cell cycle arrest, a state known as cellular senescence. Cellular senescence is mediated by activation of specific cellular signaling pathways ...

An enzyme that blocks cellular senescence and its mechanisms has been discovered by a research team from Kumamoto University, Japan. They found that a reduction of the enzyme SETD8, which regulates cell proliferation and ...

Mayo Clinic researchers have uncovered three new agents to add to the emerging repertoire of drugs that aim to delay the onset of aging by targeting senescent cells - cells that contribute to frailty and other age-related ...

Researchers at Mayo Clinic have shown that senescent cells - cells that no longer divide and accumulate with age - negatively impact health and shorten lifespan by as much as 35 percent in normal mice. The results, which ...

A Mayo Clinic study has shown evidence linking the biology of aging with idiopathic pulmonary fibrosis, a disease that impairs lung function and causes shortness of breath, fatigue, declining quality of life, and, ultimately, ...

McMaster University researchers have discovered that while survivors of childhood brain tumours have a similar Body Mass Index (BMI) to healthy children with no cancer, they have more fat tissue overall, and especially around ...

Wellcome Trust Sanger Institute scientists and their collaborators at the University of Cambridge have created a new technique that simplifies the production of human brain and muscle cells - allowing millions of functional ...

Regular infusions of a peptide that can selectively seek out and destroy broken-down cells that hamper proper tissue renewal, called senescent cells, showed evidence of improving healthspan in naturally-aged mice and mice ...

Scientists at The Rockefeller University have mapped the three-dimensional structure for one of the more notorious disease-causing molecules in the human body: the protein responsible for the genetic disorder cystic fibrosis. ...

A new study from the University of South Carolina has found a gastrointestinal link that could help explain many of the health issues facing those with Gulf War Illness (GWI) as well as opening new pathways to treatment options ...

People with cystic fibrosis (CF) suffer repeated lung infections because their airway mucus is too thick and sticky to keep bacteria, viruses, and other pathogens from causing chronic infection. How mucus becomes abnormal ...

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Measuring Heart Toxicity of Cancer Drugs – Technology Networks

Posted: March 24, 2017 at 3:42 pm

A stem cell-derived heart muscle cell. Proteins that are important for muscle cell contraction are highlighted in red and green, and cell nuclei are blue. Credit: Joseph C. Wu, M.D., Ph.D., Stanford Cardiovascular Institute

Using human heart cells generated from adult stem cells, researchers have developed an index that may be used to determine how toxic a group of cancer drugs, called tyrosine kinase inhibitors (TKIs), are to human cells. While 26 TKIs are currently used to treat a variety of cancers, some can severely damage patients hearts, causing problems such as an irregular heartbeat or heart failure.

For the study, reported February 15 in Science Translational Medicine, the researchers used stem cell-derived heart cells from 13 volunteers to develop a cardiac safety index that measures the extent to which TKIs kill or alter the function of heart cells. They found that the TKIs' toxicity score on the index was generally consistent with what is known about each drug's heart-related side effects.

This work follows on the heels of an earlier study from the same research team, published in Nature Medicine, in which they assessed the heart cell toxicity of doxorubicin, a chemotherapy drug that also causes heart-related side effects, including heart failure. In that study, the researchers used stem cell-derived heart cells from women with breast cancer to correctly predict how sensitive each womans heart cells were to doxorubicin.

Such tests could ultimately help the pharmaceutical industry identify drugs that cause heart-related side effects earlier in the drug development process and help the Food and Drug Administration (FDA) during the drug review and approval process, said the study's senior author Joseph C. Wu, M.D., Ph.D., director of the Stanford Cardiovascular Institute.

I hope this research will be helpful for individual patients, once we further implement precision medicine approaches, he added.

Ranking Heart Toxicity

To assess the potential risk of heart toxicity for drugs in development, pharmaceutical companies use laboratory tests involving animals (usually rats or mice) or cells from animals or humans that are engineered to artificially express heart-related genes. Drug candidates that appear to have an acceptable balance of benefits and risks typically proceed to testing in human clinical trials.

But there can be biological differences between these existing models and humans, so non-clinical lab tests can have significant limitations, explained Dr. Wu.

Currently, the first time humans are exposed to a new drug is during clinical trials, he said. We think it would be great if you could actually expose patients heart, brain, liver, or kidney cells to a drug in the lab, prior to clinical treatment, allowing researchers to determine whether the drug has any toxic effects.

Dr. Wu, a cardiologist by training, studies toxicities cancer drugs cause in heart cells. Human heart muscle cells (called cardiomyocytes), however, are hard to obtainrequiring risky heart surgery that may be of no direct benefit to the patientand are notoriously difficult to grow in the lab.

As an alternative, researchers have developed a method to produce heart cells from human induced pluripotent stem cells (hiPSCs). hiPSCs are created by genetically engineering normal human skin or blood cells to express four specific genes that induce them to act like stem cells. Chemical treatments can prompt hiPSCs to develop into mature cell types, such as heart muscle cells.

A large body of research has established that human adult stem cell-derived heart cells, which function and grow in cell culture, can be used as an initial model to screen drug compounds for toxic effects on the heart, said Myrtle Davis, Ph.D., chief of the Toxicology and Pharmacology Branch of NCIs Division of Cancer Treatment and Diagnosis, who was not involved in the studies.

For the Science Translational Medicine study, Dr. Wu and his colleagues set out to determine if a panel of human stem cell-derived heart cells could be used to evaluate the heart toxicity of 21 different FDA-approved TKIs.

They generated hiPSC-derived heart endothelial, fibroblast, and muscle cells from 13 volunteers: 11 healthy individuals and 2 people with kidney cancer who were being treated with a TKI. Using drug concentrations equivalent to what patients receive, the investigators next determined how lethal each TKI was to the heart cells.

They found that several TKIs were very lethal to endothelial, fibroblast, and heart muscle cells from all 13 individuals, while others were more benign.

Stem cell-derived heart muscle cells grown in a dish spontaneously contract as a beating heart does, so the researchers also analyzed the effects of TKIs on the cells beat rate, or contractility. They found that several TKIs altered the cells beat rate before they were killed by the drug treatment. If severe enough, an irregular heartbeat (called an arrhythmia), can disrupt normal heart function.

From these lethality and contractility experiments, the team developed a cardiac safety index, a 0-to-1 scale that identifies how toxic a TKI is to heart cells (with 0 being the most toxic). They then used the index to rank the 21 TKIs. The control treatment scored a 1, while a few TKIs that are labeled by the FDA with boxed warnings for severe heart toxicity scored close to 0.

Safety indices like this one can be very useful during drug discovery, said Dr. Davis, and the applicability of the index developed by Dr. Wu and his colleagues will become clear when they evaluate its performance with more compounds.

And for the safety index to be applicable to more patients, the panel of cells used to develop it would need to be gathered from a sufficiently representative population of people reflecting different ages, races/ethnicities, health statuses, and other characteristics, said Lori Minasian, M.D., deputy director of NCIs Division of Cancer Prevention, who was not involved in either study.

For example, the study did not include cells derived from patients with [pre-existing] cardiac disease, said Dr. Davis.

A Personalized Approach

In addition to their potential application during drug development, Dr. Wu believes that stem cell-derived heart cells could potentially be used to predict toxicity risk for individual patients. He and his colleagues explored this possibility in their Nature Medicine study.

Doxorubicin, used on its own or in combination with other drugs, is an effective treatment for breast cancer and several other types of cancer. Like TKIs, however, it is known to cause heart toxicities, such as arrhythmias and heart failure, in a small proportion of patients. But there has been no way to predict which patients will experience these side effects.

The researchers developed stem cell-derived heart cells from eight women with breast cancer who had been treated with doxorubicinhalf of whom experienced cardiotoxicity from the treatment and half who did not.

In several different lab tests, the heart cells from women who had experienced cardiotoxicity were more sensitive to doxorubicin than those from women who had not. More specifically, in heart cells from women who had experienced cardiotoxicity, doxorubicin treatment caused more severe irregularities in cell contractility, and even low concentrations of the drug killed the cells.

An Improved Model

While the stem cell-derived heart cell model may be an improvement over the current [drug testing] system, its not perfect, said Dr. Minasian. For example, the model does not capture contributions of other organs and cells to the toxic effects of a drug, she explained. The drug may be broken down in the liver, for instance, and side products (called metabolites) may also cause toxic effects.

In addition, the lab-grown stem cell-derived version of someones heart cells are not going to be exactly the same as the cells found in that persons heart, Dr. Wu noted. Nevertheless, they reflect the same genetics and they are pretty good at predicting drug response, he said.

Looking forward, Dr. Minasian said, figuring out how to best use this approach is going to take more work, but being able to better predict human response [to cancer drugs] is important.

The research teams next steps include conducting prospective studies to determine whether they can use a patients stem cell-derived heart cells to potentially predict if that person will develop heart toxicity before they actually receive cancer treatment.

This article has been republished frommaterialsprovided byNCI. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference

Sharma, A., Burridge, P. W., McKeithan, W. L., Serrano, R., Shukla, P., Sayed, N., ... & Matsa, E. (2017). High-throughput screening of tyrosine kinase inhibitor cardiotoxicity with human induced pluripotent stem cells. Science translational medicine, 9(377), eaaf2584.

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Cell Therapy Manufacturing Market (2017-2027): Near-Term Demand Driven by Clincial Candidates – Research and … – PR Newswire (press release)

Posted: March 24, 2017 at 3:42 pm

The Cell Therapy Manufacturing Market, 2017-2027 report provides an extensive study of the rapidly growing market of cell therapy manufacturing and focuses both on contract manufacturers and cell therapy developers with in-house manufacturing facilities. These therapies are anticipated to emerge as viable alternatives to conventional treatment options.

The scope of this report primarily includes manufacturing of advanced therapy medicinal products (ATMPs) that involve the use of immune cells such as T-cells, Tregs, dendritic cells, tumor cells and NK cells, and stem cells such as adult stem cells, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).

Several players, including cell therapy developers, research institutes, contract manufacturing organizations, and government and non-profit organizations, are playing a critical role in the development and manufacturing of these cell therapies. In fact, a number of these players have made heavy investments to expand their existing capabilities and establish new facilities for cell therapy products in order to meet the increasing demand.

Additionally, stakeholders have received significant support from governments worldwide, in terms of funding and establishment of consortiums to accelerate the transition of these therapies from laboratories to clinics. It is important to highlight that companies that offer logistics and operational services have developed systems / tools for safer and quicker delivery of therapies from manufacturing sites to patients; this has been identified as one of the key challenges in the overall development process.

The near-term demand for manufacturing of cell-based therapies will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage therapies (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for cell therapy manufacturing to grow at an annualized growth rate of -42% over the course of next ten years and be worth over USD 4 billion in 2027.

Companies Mentioned

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. CELL THERAPY MANUFACTURING: INTRODUCTION

4. MARKET OVERVIEW

5. ROADMAPS: POTENTIAL STRATEGIES TO OVERCOME EXISTING CHALLENGES

6. CELL THERAPY MANUFACTURING: IN-HOUSE MANUFACTURERS

7. CELL THERAPY MANUFACTURING: INDUSTRY PLAYERS

8. CELL THERAPY MANUFACTURING: NON-INDUSTRY PLAYERS

9. ROLE OF NON-PROFIT ORGANIZATIONS

10. RECENT DEVELOPMENTS

11. MARKET SIZING AND FORECAST

12. SWOT ANALYSIS

13. CONCLUSION

14. SURVEY ANALYSIS

15. INTERVIEW TRANSCRIPT

For more information about this report visit http://www.researchandmarkets.com/research/z9w7mt/cell_therapy

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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Cell Therapy Manufacturing Market (2017-2027): Near-Term Demand Driven by Clincial Candidates - Research and ... - PR Newswire (press release)

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Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says – KQED

Posted: March 24, 2017 at 3:42 pm

A small stem cell trial in which patients with severe spinal injuriesappeared to make remarkable progress is still showing excellent results, according to the company conductingthe research.

One of the patients in the trial is 21-year-old Kris Boesen, from Bakersfield, California, whose story we reported on last year.A car crash had left theBakersfield, California native with three crushed vertebrae, almost no feeling below his neck, and a grimprognosis. Doctors believed he would live the rest of his life as a paraplegic.

Enter stem cell therapy. Most treatments for serious spinal injuries concentrate on physical therapy to expand the range of the patients remainingmotor skills and to limit further injury, not to reverse the actual damage. But last April, as part of an experimental phase 2 clinical trial called SCiStar, researchers injected Boesen with 10 million stem cells. By July, hehad recovered use of his hands to the point where he could use a wheelchair, a computer and a cellphone, and could take care of most of his daily living needs.In recent months his progress has continued, says his father.

Boesen is not the only patient to have improved in the trial, according toAsterias Biotherapeutics, which is conducting the research. Boesen is part of a cohort of six patients who were experiencing various levels of paralysis and were injected with the 10 million stem cell dose. In a Jan. 24update, the company saidfive of those patientshad improved either one or twolevels on a widely used scale to measuremotor function in spinal injury patients.

On Tuesday, Asterias issued a newupdate, announcingthat the sixth patient in the cohort has experienced a similar improvement.

While spontaneous recovery for spinal injury patients does occur,the likelihood of all six patients recovering to the degree they haveis less likely, researchers say.

This is as good as you could hope at this point, said Charles Liu, Boesens neurosurgeon and director of the USC Neurorestoration Center. So far all the evidence is pointing in the right direction.

To measure improvement in spinal injury patients, researchers use two yardsticks: the Upper Extremity Motor Scale, or UEMS, and the International Standards for Neurological Classification of Spinal Cord Injury, or ISNCSCI. On the UEMS scale,patients are scored from 0 to 5 on theirability to use five key muscles in the wrists, elbows and fingers. The ISNCSCI scale assesses where damage has occurred along the different levels of the cervical vertebrae, which generally determines the scope of impairment to the body and the level of care needed.

For instance, if a patient has sustained damage at the fourth cervical vertebra down, known as C-4, at the base of the neck, it generally means that person is paralyzed from the neck down, requiring round-the-clock care and a ventilator to breathe.A patient with a C-5 injury may not be able to move her arms or hands, requiring about 6 to 12 hours per day of assisted care; and at the C-6 level, better motor function mayallow a patient to take care of most of herdaily living needs on her own.

Which is all to say that even one level of recovery could substantially improve the daily life ofa spinal injury patient.

According to Asterias, all six patients in the 10million-cell cohort have improved their general UEMS scores, and jumped at least one motor level on the ISNCSCI scale on one or both sides of their body.

Two patients have improvedtwo motor levels on one side; and one patient,Boesen, has improved two motor levels on both sides.

Steve Cartt, president and CEO of Asterias, said anotherpatient, Jake Javier of Danville, California, has gonefrom partial paralysis to being able to use his hands well enough to considerpursuing a computer science career.

Throws Like a Regular Throw

In September, Boesens father, Rod Boesen, told us how excited he wasthat his son had regained some feeling in one of his feet. Last week, at11 months post-injection, the elder Boesensaid Kris has continued to improve.

Now he can move his toe and his knee together at the same time, Boesen said. Theyre about to give him a manual wheelchair now [instead of a motorized one]. He can grip with his hands enough to use a manual one.

Boesen said the movement in his sons arms and hands has greatlyimproved since September.Kris, a formerhigh school pitcher, had beenflinging a ball to his dog like people throw hand grenades, Boesen said. They kind of cradle them and thats how Kris would do it. But now he throws like a regular throw, tosses that ball down the hall, has that release point down, and just wings it.

Asterias is currently recruiting patients for a trial in which theyll receive 20 million stem cells, the optimal dose, according to company researchers. Two patients have already started the 20 million stem cell therapy, and six-month results from those patients will be released in the fall, Cartt said.

Patients who received 2 million stem cells in an earlier phase of the study have not shown much change in their condition, according to the Jan. 24 update.

Guarded Optimism

While Boesens father is impressed with the results, the optimism of researchers inside and outside the studyhas been guarded.The trial is still in its early stages, and the sample size is small, said Paul Knoepfler, a cell biology professor and stem cell researcher at UC Davis, who is not involved in the SCiStar study.

As a scientist, I still would want to wait for more data, Knoepfler said. Its certainly interesting, but its still early. Its a phase 2 trial.

To address the issue of small sample size, Asterias islooking at historical data to determinethe level of improvement for patients in similar circumstances who did not receive stem cell therapy. The company has said it found a meaningful difference in the recovery of its study patients compared to the norm.

Liu said one of the most importantresults is the lack of significant side effects or other negative outcomes resulting from the treatment to date.

Thats very significant to me, Liu said. Thats the first thing you look for, is anyone hurt from this therapy.

There was also a concern, he said, that some patients might regress over time, once the initial injection of stem cells wore off. Thathasyet to occur.

No one has lost anything theyve gained, Liu said. We were very happy to see that. This is all very promising.

The next step for the SCiStartrial will be to establish a control group, Cartt said.

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Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says - KQED

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Failed cell therapy study offers positives, raises new questions – ModernMedicine

Posted: March 24, 2017 at 3:42 pm

Patients with a history of frequent anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of age-related macular degeneration (AMD) may not be the best potential candidates for encapsulated cell technology (ECT).

ECT contains human cell lines that are capable of producing a variety of proteins. After a single surgical implantation, they can produce proteins for up to two years or more, according to Szilard Kiss, MD, assistant professor of ophthalmology; director of clinical research at Weill Cornell Medical College, New York.

These cell lines survive even after being inside the human eye for six months, Dr. Kiss said.

A phase II study was initiated to compare the third generation of ECT (Neurotech, Cumberland, RI) to aflibercept (Eylea, Regeneron Pharmaceuticals). The study planned to enroll 90 subjects, with a primary outcome of non-inferiority to aflibercept alone after 108 weeks. Among the patient entry criteria, all patients had to have shown a response to aflibercept before randomization.

The patient profile was similar to other anti-VEGF treatment studies, with a best corrected visual acuity (BCVA) between 80 letters (20/25) and 35 letters (20/200) at baseline; limited pathology (such as fibrosis, scarring, or atrophy); good optical coherence tomography (OCT) response to injections; and having gone through at least three previous injections, with the last injection no more than four months before study enrollment.

The goal was to have fewer than 20% of patients needing a rescue injection during the follow-up period, Dr. Kiss said.

Study particulars

Unfortunately, there was not a significant difference between the implanted patients and those that received aflibercept. Those subjects that went on to 24 weeks may appear to have gained a little bit of vision, and one subject seemed to benefit, Dr. Kiss said. The OCT results show a saw-toothed pattern that we can see in patients who are treated with aflibercept every 8 weeks.

Although the responses look impressive, most subjects underwent rescue injections of aflibercept, Dr. Kiss said.

The time to rescue injections actually occurred as soon as 4 weeks after the implantation. And as such, there was early termination of the study, because it was not going to meet the primary endpoint of fewer than 20% needing injections, Dr. Kiss said.

However, the implantation itself was deemed successful, as the cells survived and produced the anti-VEGF molecule, but the amount that was produced was significantly below the 12 g/mL necessary.

There were two outlier subjects who had received an aflibercept injection alone about 10 days before the explant, and before measuring anti-VEGF activity. Dr. Kiss believes that to be the cause of the higher numbers compared to other subjects in the study.

None of the explants who did not receive aflibercept right before the explant produced enough anti-VEGF activity, he said.

Positive take-home

However, there had been indications the technology would be successful for this indicationa patient who had undergone six aflibercept injections during the previous year before enrollment did not need any injections (rescue therapy) during the 28 weeks before the AMD study terminated.

On the positive side, Dr. Kiss said the study results created new questions for the technologyincluding whether the approach could achieve better outcomes compared to real-world experience with other patient populations since the cell viability and stability was good.

The third generation ECT (NCT-503-3) did achieve the goal of improved VEGF-receptor production by at least 2-fold compared to double ECT (NT-503-2) implants. Further, while VEGF levels were not detectable, a complex formation was observed in the preliminary native gel.

While the AMD study has been halted, the company is investigating the technology in an ongoing phase II study in conjunction with the MacTel Project to investigate the long-term delivery of ciliary neurotrophic factor (CNTF) in people with macular telangiectasia (MacTel). A pilot study of neuro-enhancement in subjects with early visual impairment in collaboration with clinicians at Stanford University is also under way.

Most promising is that ECT is a unique and versatile drug delivery platform, with more than 1,000 patient years of safety data, Dr. Kiss added. The long-term continuous release of therapeutic proteins via ECT remains a viable and effective way to treat chronic ocular conditions.

Szilard Kiss, MD

E:[emailprotected]

This article is adapted from a presentation that Dr. Kiss presented at the Retina Subspecialty Day, prior to the 2016 American Academy of Ophthalmology meeting.

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Failed cell therapy study offers positives, raises new questions - ModernMedicine

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