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Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. The post Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run appeared first on Pharmaceutical Technology.
Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs. Yet this is far from straightforward.
. – A Purdue University engineering innovator has developed a cloud-based platform aimed at mapping inter-industry dependence networks for materials and waste generation among manufacturers in sectors such as chemicals, pharmaceuticals and other industries tied to biobased economies.
Ginkgo Bioworks has strengthened its end-to-end R&D capabilities in gene therapy with the purchase of adeno-associated virus (AAV) capsid discovery and engineering assets from StrideBio, for an undisclosed sum. As part of the transaction, one StrideBio employee will be transferred to Ginkgo’s mammalian engineering team.
ElevateBio has entered a partnership with Affini-T Therapeutics to progress the latter’s engineered TCR-T therapies focused on Kirsten rat sarcoma viral oncogene homolog (KRAS), a dominant oncogenic driver mutation in solid tumours.
— Ten Sandia National Laboratories engineers received Black Engineer of the Year Awards, including Most Promising Scientist, Modern Technology Leaders and Science Spectrum Trailblazers. Ten pre-eminent problem solvers honored for scientific, community feats Credit: Randy Montoya ALBUQUERQUE, N.M.
A leader from ACG Engineering shares insight on how âsmartâ drug manufacturing, accelerated by COVID-19, can best be put to work now and in months to come.
Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. A cGMP-compliant production facility will be housed at the centre for manufacturing cell products at scale. The RMR Group is redeveloping the property into Unison Elliott Bay.
Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work. This thought leadership series has been paid and developed by Kite, a Gilead Company. The journey of the cell.
However, scaling processes up to a manufacturing scale is far from straightforward. The challenges with scaling up mAbs therapy production When developing a mAb therapeutic, there has traditionally been inconsistency between early lab processes, pilot processes and commercial manufacturing.
CytoImmune Therapeutics, a clinical-stage immunotherapy company developing a novel class of engineered natural killer (NK) cell-based cancer therapies, has announced the opening of its clinical cell manufacturing facility in Toa Baja, Puerto Rico.
Best practices include the use of contained engineering solutions to safeguard drug product integrity and protect operators. This versatility eliminates the need to manufacture separate stock-keeping units (SKUs) for each dosage variation, streamlining inventory management and reducing production costs for pharmaceutical companies.
Credit: Victoria Chen/Alwin Daus/Pop Lab Ultrathin, flexible computer circuits have been an engineering goal for years, but technical hurdles have prevented the degree of miniaturization necessary to achieve high performance.
French drugmaker wants the efficiency of its manufacturing operations to go up a gear, and has joined forces with Formula One racing team McLaren to make it happen. The post Sanofi revs up manufacturing with help from McLaren appeared first on.
According to Tom Lenaerts, Head of Global Process Engineering at Datwyler, this transformation will reshape the entire healthcare ecosystem. Along the way, the company hopes to find new possibilities to transform its manufacturing processes and improve product quality. Disruptive technologies.
Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Compared to other dosage forms, tablets are simpler to manufacture, package, and transport.
Industry-leading cold storage manufacturers are engineering new solutions that can reliably meet performance benchmarks while consuming far less energy than yesterday’s ULT and laboratory-grade freezers.
With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.
The iPSC-based allogeneic cell therapy platform of Umoja leverages its synthetic receptor enabled differentiation (ShRED) manufacturing process to guide iCIL differentiation and development with robust anti-tumour activity. In the initial stage, the partnership will focus on acute myeloid leukaemia (AML) to boost accessibility to patients.
Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.
Symvess is a one-time, single-use, acellular tissue-engineered vessel (ATEV) composed of human extracellular matrix proteins. Manufactured using vascular smooth muscle cells derived from human aortic tissue, Symvess offers a novel solution for patients with traumatic vascular injuries.
Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).
The company has presently attained steady manufacturing of several innovative vaccines and set up a supply chain worldwide to increase accessibility to quality vaccine products for people globally.
The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. The totality of preclinical, manufacturing and clinical trial findings that were submitted for analysis formed the basis for the EUA.
The conceptualisation, development and manufacturing of primary packaging in the pharmaceutical industry require a meticulous and multi-disciplinary approach to ensure that the products meet the highest standards of safety and efficacy.
For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The enzymes must be manufactured under cGMP conditions – completely free of animal-derived ingredients.”. Developing best-in-class speciality enzymes.
It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. Expertise in analytical testing, validation, and quality control are also essential.
This years honorees tackle the sectors biggest challenges: cutting waste, boosting nutrition and engineering better flavor without compromise. Its platform delivers ingredient solutions for both chefs and food manufacturers, all while diverting tons of waste.
Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Regulators in Japan have granted approval for the manufacturing plant of Kite in El Segundo, California, US, to produce Yescarta for the Japanese market.
As per the initial agreement, Sanofi is in charge of these products’ development, manufacturing and marketing while Innate Pharma is entitled to get up to $423.3m (€400m) in development and commercial milestone payments.
Telstar will be actively participating at CPhI, to be held in Milan, during 9-11th November 2021, promoting its personalized GMP consultancy & engineering reply to the new trends in pharma. The post Telstar promotes 360º solutions at CPhI Worldwide-2021 appeared first on Pharma Mirror Magazine.
The technology platforms include the Life Edit gene editing platform, an RNA, cell, protein, vector engineering and induced pluripotent stem cells (iPSCs) platform. ElevateBio intends to use the funds to advance its genetic medicine current good manufacturing practice (cGMP) and process development business, BaseCamp.
CAMBRIDGE, MA — Perovskites are a family of materials that are currently the leading contender to potentially replace today’s silicon-based solar photovoltaics.
Inceptor Bio has partnered with cell engineering technology company Avectas to improve CAR-T cell therapies’ development and manufacturing to treat solid tumours. Under the collaboration deal, Inceptor Bio will use the Solupore technology from Avectas instead of electroporation for engineering T cells to yield a healthier T cell.
By Michael von Papen, Chief Expert at Pharmatec GmbH – a Syntegon Company When a leading global collagenase manufacturer wants to renew and optimize a system at the heart of its production, technical expertise, and engineering competence is paramount. Moreover, cooperation within the project team needs to be well organized.
From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR).
A research team in Korea has synthesized metal nanoparticles that can drastically improve the performance of hydrogen fuel cell catalysts by using the semiconductor manufacturing technology.
Borrowing a technique from inkjet printers, researchers at Princeton Engineering have rolled out a pixel-by-pixel method to program and manufacture soft structures for use in robotics, biomedical devices or architectural features.
Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. AstraZeneca will make an upfront payment to Quell of $85m, mostly in cash.
Credit: Pavel Odinev / Skoltech Scientists from the Skoltech Center for Design, Manufacturing, and Materials (CDMM) have developed a method for designing and manufacturing complex-shaped ceramic bone implants with a controllable porous structure, which largely enhances tissue fusion efficiency.
But despite this surge in demand, research from GlobalData shows that many CMOs have decreased in-house, non-containment, small molecule manufacturing. These turnkey solutions cover every process through the drug manufacturing life cycle. Finding the right solution. Their active properties must remain intact.
Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced the completion of the initial phase of investment at its site in Dudley, UK to create the company’s centre of excellence for research into commercial applications of continuous flow chemistry.
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