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 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

Vaccines are among the best tools we have to protect people’s health. And yet, public confidence in vaccines is under threat as never before. So what can we do to stop this dangerous trend and rebuild public trust? A new global policy approach is needed, one that takes public concerns seriously, builds more time for dialogue and patient consultation into increasingly stressed health services, supports public health officials and professionals to build their own confidence and have the answers they need when confronted with questions and concerns. At the same time, we must not shy away from confronting those who undermine the facts behind vaccine safety, real risks and benefits. Otherwise, there is a serious risk that global immunization goals could be undermined and public health compromised.

Spotlight

Vaccines are among the best tools we have to protect people’s health. And yet, public confidence in vaccines is under threat as never before. So what can we do to stop this dangerous trend and rebuild public trust? A new global policy approach is needed, one that takes public concerns seriously, builds more time for dialogue and patient consultation into increasingly stressed health services, supports public health officials and professionals to build their own confidence and have the answers they need when confronted with questions and concerns. At the same time, we must not shy away from confronting those who undermine the facts behind vaccine safety, real risks and benefits. Otherwise, there is a serious risk that global immunization goals could be undermined and public health compromised.

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BUSINESS INSIGHTS

Catalent to Acquire Metrics Contract Services for $475 Million to Expand High-Potent Capabilities and Oral Development and Manufacturing Capacity

Catalent, Inc. | August 10, 2022

Catalent, Inc. the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that it has reached an agreement to acquire Metrics Contract Services a full-service specialty Contract Development and Manufacturing Organization with a facility in Greenville, North Carolina, for $475 million from Mayne Pharma Group Limited. Upon completion, the acquisition will strengthen Catalent’s capabilities in integrated oral solid formulation development, manufacturing, and packaging to help customers simplify and accelerate their programs, while also expanding Catalent's capacity to handle highly potent compounds. The 333,000 square-foot Greenville facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlined one-site solution. Over the past five years, the facility has seen more than $100 million in capital improvements and now includes 16 manufacturing suites, with 11 designed to handle highly potent compounds, as well as two packaging lines that can support a large variety of development and commercial supply programs. The facility’s estimated annual production capacity exceeds one billion oral solid dose units. “This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas,” said Dr. Aris Gennadios, Group President of Catalent’s Pharma & Consumer Health segment. “Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers,” Scott Richards, Chief Executive Officer of Mayne Pharma The new facility will seamlessly integrate into Catalent’s industry-leading oral development and manufacturing network, which includes flagship sites for large-scale and controlled release oral solids manufacturing in Winchester, Kentucky; softgel development and manufacturing in St. Petersburg, Florida; and additional facilities with bioavailability enhancement technologies and complex oral solids manufacturing platforms. The acquisition is expected to close before the end of this calendar year, subject to customary closing conditions, and the entire team of over 400 employees will join Catalent. Mayne Pharma and Catalent have also agreed on the terms of a long-term supply agreement whereby the Greenville facility will continue to manufacture multiple Mayne Pharma products. Catalent will pay the purchase price for this all-cash acquisition using a combination of cash on hand, existing credit facilities, and, depending on market conditions, potentially new debt financing. The closing of the acquisition is not contingent on any financing activity. ABOUT CATALENT Catalent, Inc. an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the industry’s preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce of approximately 19,000 includes more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. ABOUT METRICS CONTRACT SERVICES Metrics Contract Services, a division of Mayne Pharma Group Limited, is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering proven scientific and operational excellence for novel oral dosage forms. Metrics provides formulation development, analytical testing and commercial manufacturing from its single-campus facility in Greenville, North Carolina

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PHARMA TECH

Nucleai Announces a Partnership with Sirona Dx for AI-Driven Discovery of Novel Spatial Biomarkers in Solid Tumors

Nucleai and Sirona Dx | July 14, 2022

Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, and Sirona Dx, a leading provider of multiomic single-cell analytical services, today announced a collaboration to advance the discovery of novel spatial biomarkers in solid tumors. The partnership combines Nucleai’s powerful AI spatial analytics platform with Sirona Dx’s leading multiplex assay development expertise to identify novel spatial signatures in high-plex assays that predict response to therapy and inform treatment decisions. Through this strategic collaboration, Sirona Dx will provide Nucleai and its customers with a CRO partner that will enable the deployment of AI-based diagnostic algorithms to support biopharma clinical trials. Nucleai’s robust computational AI-powered spatial biology algorithm supports various image modalities and cancer indications, offering a highly customizable, deployable solution across the drug development ecosystem. These capabilities earned Nucleai the position of one of the top 10 spatial biology companies in 2022. “Multiplex imaging technologies have improved rapidly over the years; however, identifying actionable insights from all the data collected remains immensely challenging. This powerful synergy between Sirona Dx and Nucleai is very exciting as it will allow us to identify actionable spatial signatures that can predict response to immunotherapy.” Avi Veidman, Co-Founder & Chief Executive Officer of Nucleai Sirona Dx is recognized as the original pioneers of spatial biology, having launched the first spatial-omics CRO service to biopharma in 2018. Today, their technology-agnostic, spatial biology suite includes the leading multiplexed imaging platforms and combines deep technical expertise required to develop high-performance multiplexed assays as large as 50 markers. Sophisticated multiplexed tissue imaging capabilities contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook. “We are delighted to announce a partnership with Nucleai,” said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. “Nucleai’s AI-driven analytical capabilities are exceptional. Our combined expertise in multiplexed tissue assay development, data generation and state-of-the-art analysis will unlock new spatial insights and accelerate the spatial biology revolution in precision medicine.” About Nucleai Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. About Sirona Dx Sirona Dx is a technical, CLIA accredited CRO, founded in 2016 to accelerate the pace of immunotherapy and targeted therapy development. With a leading-edge menu of specialized high complexity, single-cell proteomics and genomics services, Sirona Dx supports exploratory biomarker programs and advanced precision medicine initiatives to deliver safer and more effective treatment solutions.

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PHARMACY MARKET

BC Platforms Drives Data Enablement and Collaboration to Accelerate Precision Medicine in Asia

BC Platforms | June 07, 2022

BC Platforms a leading provider of data and technology platforms for personalized medicine and drug development, will host a key, day-long, Precision Medicine and Data Science Conference in Singapore on 7 June 2022 to discuss how stakeholders can securely collaborate and enable the use of federated data at scale to empower precision medicine, population health, and preventive care initiatives in the region. The event features preeminent local and international experts from healthcare, government, and academia, including Professor Patrick Tan, Executive Director of the Genome Institute of Singapore, Associate Professor Neerja Karnani, BioInformatics Institute A*STAR and Dr Shay Ben-Shachar, Director of Precision Medicine and Genomics at Clalit Research Institute, Israel. It is part of BCP's efforts to support the growth of precision medicine activities in Asia Pacific. "Access to connected, secure data is a key pillar in overall healthcare development. High quality clinical and genomics information is foundational to predictive and preventive clinical care as well as drug development. Today, real-world data generated from Asian countries is not represented well enough and data diversity is key to solving the most pressing research questions. At BC Platforms we recognize that Asian countries continue to remain under-represented in global life science research; so it is important for healthcare systems in the region to collaborate, build highly secure, enabling technologies and ensure local legislation is supportive of real-world data initiatives. It will allow the whole ecosystem to stay in front of the development, and our vision focuses on personalized care models for patients in this region." Mr Tero Silvola, Chief Executive Officer of BC Platforms The company had expanded its R&D operations in Singapore earlier this year and partnered with SingHealth, Singapore's largest public healthcare group. Parties aim to build a series of research projects and by doing so accelerate relevant clinical research with pressing targets on diseases prevalent in the Asian population, including but not limited to cancer and cardiovascular diseases. This highly visible partnership is part of BC Platforms' rapidly growing data partner network for secure and regulatory compliant sharing of real-world data. The BCRQUEST.com global partner network now comprises 33 million patient lives from 37 data partners on five continents. While BC Platforms has been active in Singapore since 2019, it plans to ramp up activities and continue to build its presence in the region as it continues to develop and deploy safe and secure infrastructure for healthcare data. The company is also focusing on partnerships with local and regional healthcare and research institutions to strengthen translational research capabilities in Asia Pacific and improve care outcomes for patients in the region. About BC Platforms BC Platforms is a global leader in providing a powerful data and technology platform for personalised medicine and drug development, accelerating the translation of insights into clinical practice. Our technology drives the infinite loop between personalised care and research discoveries, leveraging latest science, deep technical expertise, strategic partnerships, and harmonized, diverse data collections. Our high performing genomic data discovery and analytics platform enables flexible data integration, secure analysis, and interpretation of molecular and clinical information.

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