Pharmaceutical Technology Editors

Novo Nordisk announced on March 9, 2022 that it is expanding its existing research collaboration with the Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital (BWH) focused in oral drug delivery technologies.

Novel technologies have been explored as alternatives to syringes and pen injectors by scientists from Novo Nordisk and the laboratories of Prof. Giovanni Traverso and Prof. Robert Langer since 2015. The collaboration has explored new devices that safely and effectively deliver biologic medicines through oral administration.

The collaboration has been extended through 2026 and will expand its focus to include the creation and integration of bioelectronics, biosensors, and stimuli-responsive delivery devices.

“We continue to explore the immense potential for enhanced delivery of biologic drugs and stem cell-derived therapeutics through the platforms we are developing,” said Giovanni Traverso, the Karl van Tassel, career development assistant professor of mechanical engineering at MIT and a gastroenterologist at Brigham and Women’s Hospital, Harvard Medical School.

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Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.

Novo Nordisk Expands Research Collaboration in Novel Delivery Technologies for Biologic Medicines

Evonik has launched a new microparticle technology, EUDRATEC SoluFlow, to improve solubility of APIs in oral drug products. This emulsion-based technology is used to overcome solubility issues in oral small molecules.

The technology is able to improve solubility in oral drugs by turning them into a free-flowing powder of the amorphous solid dispersion (ASD). ASD reduces the complexity of post-processing steps by its ability to be easily compressed into tablets or filled into capsules. This process also creates the ability to manufacture uniform microparticles with a controlled target size. More than 70% of new small molecules are insoluble, making EUDRATEC a unique technology that enables the development of new oral therapeutics for a range of diseases.

“Our new technology opens doors to a wider spectrum of oral drugs by enabling the use of molecules that were previously considered insoluble,” said Paul Spencer, head of the product line Drug Delivery & Medical Device Solutions at Evonik’s Health Care business, in a press release. “We look forward to working with customers to develop oral drugs for better, healthier lives.”

Evonik has launched new EUDRATEC technology to improve solubility and performance of oral small molecules. 

Evonik Launches New EUDRATEC Technology to Improve Solubility of Oral Small Molecules

Curia, formerly AMRI, announced on March 9, 2022 that it is entering a cooperative agreement with the US government to expand and advance fill/finish capabilities for injectable medicines. The groups of the US government involved in the agreement include the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR); the Department of Defense Joint Program Executive Office or Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND); and the US Army Contracting Command.

The agreement will focus on funding to add a new high-speed fill/finish vial line, which includes biosafety level 2 (BSL-2) containment. Curia is also supporting smaller batch advanced therapies with two lyophilizers for the high-speed fill/finish line and an isolated flexible filling line for vials, syringes, and cartridges, all of which are self-funded.

The expansion will be housed at Curia’s Albuquerque, NM facility, which already supports the supply of various treatments and vaccines for cancer, cardiovascular, auto-immune, infectious, and rare diseases. The facility also is home to Curia’s “Sterile University,” a training program focused on simulating a sterile manufacturing environment for employees to develop skills that improve safety, efficacy, and accuracy in the workplace.

“This agreement assures our ability to meet urgent demands for the supply of critical medicines well into the future,” said John Ratliff, chairman and CEO of Curia, in a press release. “Scientific advances including biologics and vaccines require injectable formulations. The fill-finish of this type of product demands specialized expertise and equipment. Our investments in Curia’s Albuquerque facility have already increased capacity and added to our talented team in New Mexico. This agreement not only secures our continued contribution to the nation’s pandemic response plans, it also enables us to meet the need to deliver life-changing life science to patients into the future.”

Curia and the US government have entered into a cooperative agreement to expand fill/finish capability for injectable medicines.

Curia Enters Cooperative Agreement with US Government to Expand Sterile Fill/Finish Capability

UCB announced on March 8, 2022 that it will build a new innovative facility, focused on gene therapy process development and clinical manufacturing, in Wallonia, Belgium. The new facility will be BREEAM (Building Research Establishment Environmental Assessment Method) certified, supporting UCB’s carbon neutrality ambition to reduce resource consumption and waste production. The 17,0000-sq.-ft. facility is expected to be operational in 2024.

The development of the gene therapy field fuels a change in how diseases are treated, focusing on disease modification rather than just symptom treatment. The new facility will provide end-to-end process and analytical development, clinical manufacturing, quality control, scalability, and speed to UCB’s gene therapy research projects.

“Upon completion of our new gene therapy development and clinical manufacturing facility, UCB will have complete ownership and control of its chemistry, manufacturing and controls (CMC) capabilities, this will enable agility, flexibility, unparalleled product and process understanding, scalability, and yield improvements, all translating to a significant competitive advantage for UCB and a smart investment in the technologically evolving gene therapy landscape,” said Dr. Kirsten Lund-Jurgensen, executive VP and head of supply & technology solutions at UCB.

UCB has announced it will build a new innovative gene therapy facility in Belgium.

UCB Expands Innovation Footprint with New Gene Therapy Facility

Spectrum Chemical, a leading global manufacturer and distributer of fine chemicals, laboratory equipment, and supplies, announced on March 8, 2022 that it is expanding its bioCERTIFIED product portfolio to support the growing global demand for new vaccines and therapeutics. The product portfolio is part of an exclusive quality management system, which will meet the needs of biopharmaceutical manufacturers by providing additional testing and certifications for products.

Spectrum Chemical has added 11 new products to the portfolio, which had already included more than 100 products. The new products include sugars and various salts that will aid in upstream processing of cell culture development as well as downstream processing for biopharmaceuticals. The expansion of products is meant to support the customized needs of pharmaceutical and biopharmaceutical manufacturers as the global demand for new medicines and vaccines grows.

Spectrum Chemical has further expanded its bioCERTIFIED product portfolio to support the growing global demand for new vaccines and therapeutics. 

Spectrum Chemical Announces Expansion of bioCERTIFIED Product Portfolio to Support Global Demand for New Vaccines and Therapeutics 

Amgen announced on March 7, 2022 the groundbreaking of its new biomanufacturing facility, located in Holly Springs, NC, that is expected to be operational by 2025. The facility will support the growing demand for medicines that treat serious illnesses such as cancer and heart disease. The new facility will produce a wide range of medicines, utilizing new technologies to maximize efficiency and quality.

"For over four decades, Amgen has been an innovative leader in the manufacturing of complex biologics. Our commitment to continuous improvement and our significant investments in new technologies have enabled us to further accomplish our mission to serve patients while science rapidly evolves," said Robert A. Bradway, chairman and CEO of Amgen, in a press release. "We are delighted to be building our newest facility in North Carolina, a major hub for biopharmaceutical innovation."

The facility will be environmentally conscious, focusing on reducing water usage and waste. Amgen is also focused on increasing diversity in the workplace through the OneTen Coalition, which it is a founding member of. The Coalition’s goal is to change the employment paradigm for black people in the United States. “To achieve this goal, Amgen will work with businesses, educational institutions, and training partners to better develop, retain, and advance diverse talent, focusing on Black Americans without four-year college degrees,” the company said in the press release.

Amgen has announced the groundbreaking of its newest biomanufacturing facility in North Carolina.
