Manufacturing News and Research

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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

FDA makes the first gene therapy Kymriah available for treatment of pediatric ALL

The U.S. Food and Drug Administration (FDA) has issued a press release making the first even gene therapy available for treatment of children with a form of acute lymphoblastic leukemia (ALL).

30 Aug 2017

$Novartis gets FDA approval for novel immunocellular therapy to treat relapsed or refractory B-cell ALL$

Novartis gets FDA approval for novel immunocellular therapy to treat relapsed or refractory B-cell ALL

Novartis announced today that the US Food and Drug Administration has approved Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

30 Aug 2017

New biomedical tool using nanoparticles could improve therapies for many diseases

A new biomedical tool using nanoparticles that deliver transient gene changes to targeted cells could make therapies for a variety of diseases - including cancer, diabetes and HIV - faster and cheaper to develop, and more customizable.

30 Aug 2017

FDA approves first cell-based gene therapy for use in the United States

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

30 Aug 2017

FDA issues warning letter to US Stem Cell Clinic for significant deviations

The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.

28 Aug 2017

‘Breakthrough’ leukemia drug also portends ‘quantum leap’ in cost

When doctors talk about a new leukemia drug from Novartis, they ooze enthusiasm, using words like "breakthrough," "revolutionary" and "a watershed moment."

23 Aug 2017

Optical species identification for preservation and species identification

Species identification is important for ecological research and in particular to study the impact of natural hazards or environmental pollutants present, because it’s possible to determine the general health of the ecosystem through the diversity of life that are found in a given area.

From Teledyne FLIR Systems 22 Aug 2017

New diagnostic tool uses near-infrared light to spot patients at risk of heart attacks and strokes

Patients at risk of heart attacks and strokes may be spotted earlier thanks to a diagnosis tool that uses near-infrared light to identify high-risk arterial plaques, according to research carried out at WMG, University of Warwick, the Baker Institute and Monash University.

18 Aug 2017

Bespoke filtration equipment facilitates delivery of critical drugs to leading children’s hospital

Amazon Filters has supplied a major pharmaceutical manufacturer with bespoke filtration equipment enabling them to fulfil a contract to deliver critical drugs to a leading children’s hospital.

From Amazon Filters Ltd. 16 Aug 2017

Poplar trees fortified with probiotic effectively clean up polluted sites

Trees have the ability to capture and remove pollutants from the soil and degrade them through natural processes in the plant. It's a feat of nature companies have used to help clean up polluted sites, though only in small-scale projects.

14 Aug 2017

Portable spectral analyzer enables smartphone to perform lab-grade medical diagnostic tests

Researchers at the University of Illinois at Urbana-Champaign have developed technology that enables a smartphone to perform lab-grade medical diagnostic tests that typically require large, expensive instruments.

10 Aug 2017

New technique combines electricity and chemistry to scale up drug manufacturing

Give your medicine a jolt. By using - electrochemistry - a technique that combines electricity and chemistry, future pharmaceuticals - including many of the top prescribed medications in the United States - soon may be easily scaled up to be manufactured in a more sustainable way.

10 Aug 2017

Certain occupations may put workers at increased risk of developing rheumatoid arthritis

New research indicates that certain occupations may put workers at an elevated risk of developing rheumatoid arthritis. The findings, which appear in Arthritis Care & Research, suggest that work-related factors, such as noxious airborne agents, may contribute to the pathogenesis of rheumatoid arthritis.

10 Aug 2017

Shortage of Hepatitis B vaccine - prioritization of vaccinations announced in UK

According to a recent announcement made by Public Health England, there is a global shortage of vaccines used against hepatitis B infection. This announcement is followed up by a “prioritisation guidance” which means that persons who are at greatest risk of getting hepatitis B are to be vaccinated on priority if they have not received the vaccine before.

7 Aug 2017

Biologic substance APOSEC shows promise for healing dermal wounds

APOSEC is a substance obtained from white blood corpuscles and was developed by a research group led by thoracic surgeon Hendrik Jan Ankersmit, Head of the Christian Doppler Laboratory for Cardiac and Thoracic Diagnosis and Regeneration at MedUni Vienna.

3 Aug 2017

Researchers develop soft robotic arm for endoscopes to assist in surgical procedures

Flexible endoscopes can snake through narrow passages to treat difficult to reach areas of the body. However, once they arrive at their target, these devices rely on rigid surgical tools to manipulate or remove tissue.

2 Aug 2017

InDevR gets NIAID support for verification, validation studies on new potency test for influenza viruses

InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced support from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for verification and validation studies on a new potency test for influenza viruses with pandemic potential.

2 Aug 2017

U.S. FDA approves updated labeling for pan-genotypic single tablet regimen for HCV/HIV co-infected patients

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved updated labeling for Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

1 Aug 2017

ITL Group to celebrate 40 years of med-tech innovation at AACC

ITL Group’s global operation will be front and centre at the 69th Annual Scientific Meeting and Clinical Lab, from 29 July to 3 August in San Diego, California, marking its first appearance in 15 years.

From Vitl Life Science Solutions 1 Aug 2017

Researchers streamline beta cell differentiation process to develop safer cell therapy for diabetes

More than 36 million people globally are affected by type 1 diabetes (T1D), a lifelong disorder where insulin producing cells are attacked and destroyed by the immune system resulting in deficient insulin production that requires daily blood glucose monitoring and administration of insulin.

1 Aug 2017

Manufacturing News and Research

Further Reading

FDA makes the first gene therapy Kymriah available for treatment of pediatric ALL

Novartis gets FDA approval for novel immunocellular therapy to treat relapsed or refractory B-cell ALL

New biomedical tool using nanoparticles could improve therapies for many diseases

FDA approves first cell-based gene therapy for use in the United States

FDA issues warning letter to US Stem Cell Clinic for significant deviations

‘Breakthrough’ leukemia drug also portends ‘quantum leap’ in cost

Optical species identification for preservation and species identification

New diagnostic tool uses near-infrared light to spot patients at risk of heart attacks and strokes

Bespoke filtration equipment facilitates delivery of critical drugs to leading children’s hospital

Poplar trees fortified with probiotic effectively clean up polluted sites

Portable spectral analyzer enables smartphone to perform lab-grade medical diagnostic tests

New technique combines electricity and chemistry to scale up drug manufacturing

Certain occupations may put workers at increased risk of developing rheumatoid arthritis

Shortage of Hepatitis B vaccine - prioritization of vaccinations announced in UK

Biologic substance APOSEC shows promise for healing dermal wounds

Researchers develop soft robotic arm for endoscopes to assist in surgical procedures

InDevR gets NIAID support for verification, validation studies on new potency test for influenza viruses

U.S. FDA approves updated labeling for pan-genotypic single tablet regimen for HCV/HIV co-infected patients

ITL Group to celebrate 40 years of med-tech innovation at AACC

Researchers streamline beta cell differentiation process to develop safer cell therapy for diabetes

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