RESEARCH

Thermo Fisher sketches out Carlsbad plasmid DNA plant as German cell and gene therapy facility preps for opening

Thermo Fisher | December 23, 2020

Thermo Fisher sketches out Carlsbad plasmid DNA plant as German cell and gene therapy facility preps for opening
Thermo Fisher Scientific is shoring up production of cell and quality treatments on the two sides of the lake, a move it expectations will support the advancement of COVID-19 medications and antibodies—and guarantee supplies are set up should they get by with controllers.

The New Jersey contract producer is spreading out another plasmid DNA fabricating office at its Carlsbad, California, grounds, intending to help its phone and quality treatment contributions against the setting of a worldwide plasmid market where request has immediately dominated supply, the organization said.

That is on top of plans for another cryocenter in Germany. That webpage, one of two new German offices set to come online in the following not many weeks, will offer virus chain support for clinical preliminaries of cell and quality treatments, including COVID-19 immunization hopefuls, in Europe and past.

The 67,000-square-foot Carlsbad office will add exactly 150 positions throughout the following a year, with development fixed to enclose by the principal half of 2021, Thermo Fisher said. The site will support clinical and business yield of plasmid DNA used to create and deliver cell and quality treatments for disease, just as mRNA immunizations. It will likewise be prepared to produce huge scope plasmid DNA as an essential medication substance for DNA treatments, the organization said.

The office will be kitted out with single-utilize hardware equipped for taking care of undertakings up to 1,000 liters and will flaunt computerized network and information visibility to smooth activities and make preparing representatives simpler, Thermo Fisher said.

Thermo Fisher is no more abnormal to the field, with a phone and quality treatment impression in Massachusetts and Florida, in addition to a recently stamped cell treatment producing plant in Princeton, New Jersey—however it calculates the extended business and supply chain administrations at its Carlsbad site will smooth the wrinkles in the current plasmid market.

"The competition to grow new groundbreaking cell and quality treatments and antibodies is outperforming supply of business quality plasmid DNA that can be created at scale," Mike Shafer, SVP and leader of pharma administrations at Thermo Fisher, said in a delivery.

"Our new cutting edge site won't just handle the supply bottleneck for our clients yet in addition particularly positions us to convey powerful, start to finish cell and quality treatment capacities."

Spotlight

SCN's Jane King sits down with CEO Peter Culpepper of Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT) , to discuss the biopharmaceutical company and it's future outlook.

Related News

PHARMACY MARKET

Yangtze River Pharmaceutical Group Selects TraceLink Platform for Global Compliance

Yangtze River Pharmaceutical, TraceLink | May 06, 2021

TraceLink Inc., the leading digital network platform company, today announced that Yangtze River Pharmaceutical Group has selected TraceLink's global compliance solution to aid its plans for global growth. As the company gears up for international market expansion this year, Yangtze River Pharmaceutical Group (YRPG) will use TraceLink's multienterprise compliance applications and industry-leading digital supply network to comply with track and trace requirements in multiple markets, including the United States and Europe. "As we approach our 50th anniversary this year, we are preparing to deliver our innovations to global markets beyond China," said Mr. Luo Bai Gui GM's Executive Assistant, International Projects from YRPG. "Given the broad scope of our portfolio and diverse business model, TraceLink' s integrated network, global compliance solutions and low total cost of ownership are crucial for us to achieve commercial success in multiple markets." "Global commercialization has become a top priority during this special milestone year for YRPG and serialization compliance is a necessary step in their preparation for global expansion," said Shabbir Dahod, President and CEO, TraceLink. "As one of the top pharmaceutical enterprises in China, YRPG is highly esteemed for its relentless innovation and TraceLink is proud to be their serialization partner of record as they embark on their journey of continued global growth." With more than 16,000 employees and over 20 subsidiaries located across China, YRPG has established R&D and production bases for innovative chemical medicines, patent traditional Chinese Medicine (TCMs) and biological medicines. Yangtze River Pharmaceutical Group's products include Chinese, Western medicines and APIs, covering ten fields, nearly 20 dosage forms and over 300 types of medicines and strengths. Nearly 100 innovative drugs for major diseases are currently under research & development. About Yangtze River Pharmaceutical Group With a total manufacturing footprint of more than 3 million square meters, Yangtze River Pharmaceutical Group employs 16,000 and owns 11 manufacturing subsidiaries located in Beijing, Shanghai, Nanjing, Guangzhou, etc. The company fields established R&D and production bases for innovative chemical medicines, patent traditional Chinese Medicine (TCM) and biological medicines. Currently, Yangtze River Pharmaceutical Group exports part of its portfolio assortment to 30 countries including Europe, Asia and Africa. About TraceLink TraceLink is the only business network creation platform for building integrated business ecosystems with multienterprise applications. Business networks are the foundation of an Industry 4.0 digitalization strategy that delivers customer-centric agility and resiliency of the end-to-end supply network leveraging the collective intelligence of an industry. TraceLink's Opus Digital Network Platform enables speed of open innovation and implementation with a partner ecosystem for no-code and low-code development of solutions and applications.

Read More

PHARMACY MARKET

Takeda is poised to commercialize next generation Hunter's disease therapy through collaboration with JCR Pharmaceuticals

Takeda Pharmaceutical Company Limited | October 01, 2021

Takeda Pharmaceutical Company Limited and JCR Pharmaceuticals Co., Ltd. today announce a geographically focused exclusive collaboration and license agreement to commercialize JR-141, a recombinant fusion protein under development of a next-generation antibody against the human transferrin receptor and the enzyme iduronate- 2-sulfatase (IDS), used to treat Hunter's disease (also called mucopolysaccharidosis type II or MPS II). Hunter's disease is caused by the lack of IDS and manifests itself in different forms. Administered with J-Brain Cargo®, JCR's proprietary blood-brain barrier (BBB) ​​technology, the JR-141 was designed to deliver the therapeutic enzyme across the blood-brain barrier directly to the brain and somatic and address neuronopathic manifestations of the disease, Under the exclusive collaboration and license agreement, Takeda will exclusively market the JR-141 outside of the United States, including Canada, Europe, and other regions (excluding Japan and certain other Asia Pacific countries). JCR will receive an upfront payment for the ex-US license and is eligible to receive additional development measures and commercial milestones as well as multi-tier royalties on potential product sales. Both companies will work together to provide this form of therapy to patients as soon as possible after the completion of the global Phase III program run by JCR. Takeda has an option under a separate option agreement that allows Takeda to acquire an exclusive license to commercialize JR-141 in the United States upon completion of the Phase III program. Takeda is committed to continuously improving the therapy it offers to treat Hunter's disease. JR-141 introduces a new way of delivering proteins by crossing the blood-brain barrier. This will overcome our current challenges in treating the underlying neuronopathic manifestations of Hunter's disease and help maintain or improve cognitive function in these patients, We will work closely with JCR to apply our expertise in enzyme replacement therapies with the hope of delivering this potentially transformative form of therapy to patients as soon as possible. - Dan Curran, MD, Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda. JR-141 met its primary endpoint in an open-label Phase II / III study in Japanand was able to show a significant reduction in heparan sulfate (HS) concentrations in the CSF. HS is a biomarker for assessing the effectiveness of the drug in reducing the disease-causing substrate in the central nervous system. This proof could be provided in all patients for whom measurements were available after 52 weeks of treatment. Somatic disease control was retained in patients switched from standard enzyme replacement therapy (ERT). The study also showed an improvement in somatic symptoms in participants who had not received standard ERT prior to the start of the study. In addition, an assessment of neurocognitive development in 21 of 25 patients at one year showed the maintenance or improvement of age-appropriate function.1 About JR-141 JR-141 is a recombinant fusion protein of an antibody against the human transferrin receptor and the enzyme iduronate-2-sulfatase. This enzyme is absent or defective in patients with Hunter's disease. It is expected to be effective against neuronopathic manifestations of the disease by crossing the blood-brain barrier (BBB) ​​through transferrin receptor-mediated transcytosis using J-Brain Cargo®, JCR's proprietary BBB technology. Uptake into the cells is mediated by the transferrin receptor and the mannose-6-phosphate receptor. JCR has driven development activities by allowing the company to maintain the necessary evidence from the molecular design phase through to the non-clinical and clinical study phases. In addition, JCR has confirmed that using J-Brain Cargo® technology, enzymes are absorbed into different brain tissues. A decrease in substrate accumulation could also be confirmed in an animal model of Hunter's disease. 2,3,4 In several clinical studies with JR-141, JCR was able to show a reduction in CSF heparan sulfate concentrations. This is a biomarker for assessing the effectiveness of drugs by reducing the disease-causing substrate in the central nervous system. This is done in accordance with the results obtained in non-clinical studies. JCR also produced clinical results that could show the positive effects of JR-141 on neurocognition. 5,6,7,8 JR-141 is approved by the Ministry of Health, Labor and Social Affairs and has been marketed under the brand name "IZCARGO® IV Infusion 10mg" since May 2021. About Hunter's Disease Hunter's disease is a severely debilitating, rare lysosomal disease caused by insufficient activity of the enzyme iduronate-2-sulfatase. This enzyme has the task of breaking down substances known as glycosaminoglycans (GAG) in the body. 9 The absence of this enzyme (GAG) can trigger a number of symptoms. 9,10 Around two in three people with Hunter's disease also experience progressive loss of cognitive function. 11 Hunter's disease affects 1 in 162,000 live births and almost exclusively male patients. 12th About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited is a global, values-based, leading group with a focus on research and development in the biopharmaceutical sector headquartered in Japan. His pursuit of life-changing treatments is shaped by his dedication to patients, people, and the planet. Takeda's research and development efforts focus on four therapeutic areas: Oncology, Rare Genetic Diseases and Hematology, Neuroscience and Gastroenterology (GI). We also invest parts of our research and development budget specifically in therapies with plasma derivatives and vaccines. We focus on developing highly innovative drugs that help improve people's quality of life. To this end, we are opening up new treatment options and using our improved, synergistic research area and our combined skills to create a robust pipeline based on different modalities. Our employees are committed to improving the quality of life for patients and work with our healthcare partners in around 80 countries and regions. About JCR Pharmaceuticals Co., Ltd. JCR Pharmaceuticals Co., Ltd. is a global specialty pharmaceutical company that is redefining expectations and expanding opportunities for those with rare hereditary diseases around the world. We continue to build on our 46 year tradition in Japan as we expand our presence in the United States, Europe and Latin America. We improve the lives of patients by applying our scientific expertise and unique technologies to research, develop and deliver next generation therapies. Our approved products in Japan include therapies for the treatment of stunted growth, Fabry disease, acute graft versus host disease and renal anemia. Our test products, which are being developed around the world, aim, among other things, at the treatment of rare diseases, including MPS I (Hurler's disease, Hurler-Scheie and Scheie syndrome), MPS II (Hunter's disease) and Pompe disease. JCR strives to expand the possibilities for patients as the company accelerates medical advancement on a global basis. Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we reach greater heights.

Read More

PHARMACY MARKET

CURE Pharmaceutical Receives Patent Approval for Its CUREfilm Blue™ Technology

CURE Pharmaceutical Holding Corp. | November 17, 2021

CURE Pharmaceutical Holding Corp. (OTC: CURR), a technology focused, vertically integrated drug delivery and product development company focused on pharmaceutical and health & wellness products, announced today that it received an issue notification from the U.S. Patent Office (USPTO) stating that U.S. Patent No. 11,179,331 (the ’331 patent) is set to issue on November 23, 2021. The ’331 patent, entitled “Oral Soluble Film Containing Sildenafil Citrate,” covers the product CUREfilm Blue™, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra®1) for the treatment of erectile dysfunction (ED). CURE is seeking approval of this product via the 505(b)(2) regulatory pathway. CUREfilm Blue™ utilizes the Company’s patented and proprietary fast-dissolving drug delivery platform, known as CUREfilm™, to deliver the active pharmaceutical ingredient (API) sildenafil citrate. By innovating beyond the traditional pharmaceutical delivery of pills and solutions, CURE is advancing this uniquely discrete, convenient and portable oral film product for achieving a better patient experience. The ’331 patent highlights several key aspects of the CUREfilm Blue™, such as a balance of performance characteristics (e.g., fast-dissolving and early onset of action) and physical parameters (e.g., large mass and small thickness), while it can be administered with or without water or beverage. The global erectile dysfunction drug market is projected to grow at a CAGR of 6% and reach approximately USD$6.6 billion by 2025 with sildenafil representing a majority of the market, according to a report by QYR Research. About CURE Pharmaceutical Holding Corp. CURE Pharmaceutical® is the pioneering developer of CUREform™, a patented drug delivery platform that offers a number of unique immediate- and controlled-release drug delivery vehicles designed to improve drug efficacy, safety, and patient experience for a wide range of active ingredients. As a vertically integrated company, CURE’s 25,000 square foot, FDA-registered, NSF® and cGMP-certified manufacturing facility enables it to partner with pharmaceutical and wellness companies worldwide for private and white-labeled production. CURE has partnerships in the U.S., China, Mexico, Canada, Israel, and other markets in Europe. Forward Looking Statement Statements CURE makes in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. CURE intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. The forward-looking statements in this press release reflect CURE’s judgment as of the date of this press release. CURE disclaims any intent or obligation to update these forward-looking statements

Read More

Spotlight

SCN's Jane King sits down with CEO Peter Culpepper of Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT) , to discuss the biopharmaceutical company and it's future outlook.