BUSINESS INSIGHTS, PHARMA TECH
US Pharmacopeia | January 04, 2023
The United States Pharmacopeia (USP) has announced the launch of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, as a part of its launch of a suite of R&D analytical solutions. These analytical lab services will aid drug manufacturers in adopting advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM), to increase geographic diversity in pharmaceutical manufacturing and support medicine supply chain resilience.
The new R&D analytical solutions will include analytical lab services that take advantage of USP's in-house scientific expertise and cutting-edge facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as its headquarters in Rockville, Maryland. These capabilities will be utilized to characterize materials and qualify and develop ways to help ensure the quality of PCM-based medicines.
PCM involves a continuous flow of materials through a process pipeline in which two or more unit operations are directly connected and the sequential transformation of those materials. As the input materials are fed in, the process output, such as an active pharmaceutical ingredient or drug product, is collected, and the complete procedure is carried out in a single facility.
USP's emphasis on R&D analytical solutions and PCM-specific quality assessments is part of a broader set of activities aimed at addressing the problems of PCM adoption and bolstering pharmaceuticals' supply chain resilience.
Consulting services provided by a USP company, Pharmatech Associates, Inc., can assist manufacturers with decision-making and problems associated with PCM adoption. Pharmatech Associates consulting services, which operate independently of USP's standards-setting processes, provide manufacturers interested in PCM and other advanced manufacturing technologies with technical, business, and regulatory strategies, workforce training, and equipment and process design.
About The U.S. Pharmacopeia (USP)
USP is a non-profit, independent scientific organization that provides safe, high-quality pharmaceuticals. The organization has strived to establish confidence in the world's drugs, dietary supplements, and foods for more than two centuries. It protects patient safety and enhances global health via rigorous science and the establishment of public quality standards.
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BUSINESS INSIGHTS, PHARMACY MARKET
PCI Pharma Services | March 20, 2023
PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), announced plans for a new 200,000-square-foot facility in Rockford, Illinois to enhance the organization’s capacity in injectable drug-device combination product assembly of both biologics and small molecules. Building on PCI’s leadership in this space with its Philadelphia Biotech Center of Excellence, the new facility is the second expansion building off the success in Philadelphia and will house over 20 dedicated customer suites with multiformat machines for the assembly and packaging of vials, pre-filled syringes, auto-injectors, and pen-cartridge combinations. This machinery can be used for the glucagon-like peptide 1 agonists (GLP-1) class of drugs prescribed to treat diabetes and obesity, as well as those needed for oncology treatment and autoimmune diseases.
PCI’s Rockford location will have extensive product testing capability, state-of-the art top-load cartoning technology, and industry leading injector and pen assembly equipment. Additional capabilities include on-site cold storage, high-speed vial labeling, assembly, and packaging of multiformat autoinjectors, serialization, testing, and drug product release.
“We see the tremendous impact that we can make with patients with this investment,” said Salim Haffar, CEO of PCI Pharma Services. “The need for injectable drug-delivery device combination product capacity and expertise is critical, and we are responding with a world-class facility to address the future demands of our global clients so they can focus on developing therapies to improve the lives of patients with serious chronic conditions.”
The $50 million investment in Rockford will amplify PCI’s specialty drug leadership presence in the Midwest, adding to clinical and commercial sterile fill-finish capabilities in Madison, Wisconsin. The new facility will provide a second hub within the U.S., expanding from PCI’s foundation in the Northeast, with Bedford, New Hampshire’s campus growth in aseptic processing. PCI also has sterile fill-finish capabilities at its Leon, Spain; San Diego, California; and Melbourne, Australia locations. The expansion in Rockford is expected to bring 250 jobs to the region in the next two years, with continued growth over three to five years. The site is expected to be fully operational in summer 2024.
“With this new facility, we will be able to serve all clients focused on injectable drug products including biologics with the equipment and capacity to make life-changing medicines,” said Gil Valadez, Senior Vice President, Commercial Packaging Technology, PCI Pharma Services. “We want to help our clients by managing the technical aspects of drug manufacturing, engineering, and delivery, so they can focus on what’s most important: delivering quality products to meet patient needs. That's what PCI is ultimately all about.”
About the Rockford, IL Facility
Rockford is the largest of PCI’s 30 locations across the U.S., European, and Asia Pacific regions, providing industry-leading services for the clinical and commercial packaging of a diverse portfolio of products and specialized delivery forms destined to reach more than 100 countries across the world. The gated secured facility is classified by the Drug Enforcement Administration (DEA) as Schedule 3. It features temperature and humidity control, an approved Foreign Trade Zone (FTZ) and offers TF1 and Uhlmann blistering, vibratory and slat filler bottling, powder filling, cartoning, carding, kitting and serialization capabilities. Warehouse storage includes freezer storage -15°C to -30°C and cold storage 2°C to 8°C.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 5,000 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.
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BUSINESS INSIGHTS, PHARMA TECH
Tonix Pharmaceuticals | February 14, 2023
On February 13, 2023, Tonix Pharmaceuticals, a leading clinical-stage biopharmaceutical firm, announced that it has exercised an option to acquire an exclusive license from Columbia University to develop a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the prophylaxis or treatment of SARS-CoV-2 infection. COVID-19 is caused by SARS-CoV-2. Tonix Pharmaceuticals and Columbia University announced a research collaboration and option agreement in 2020, which resulted in the development of the licensed mAbs.
Although the FDA granted emergency use authorization (EUA) to five mAb products containing seven distinct mAbs for either prophylaxis or treatment of COVID-19, none stayed available or functional since January 26, 2023, when the FDA stated that the last remaining mAb, Evusheld®, is no longer authorized. Previously, either FDA or the National Institutes of Health COVID Treatment Guidelines Panel had revoked recommendations or clearances for the other mAbs.
Until recently, the earlier EUA-approved products were obtained from the blood of humanized mice or COVID-convalescent patients. Columbia University's TNX-3600 fully human mAbs were generated utilizing a proprietary system that involved a human hybridoma fusion partner.
The firm feels that murine monoclonal antibodies, such as TNX-4100, have the capacity to generate antibodies with a high affinity that detect distinct epitopes on the SARS-CoV-2 spike protein. This is due to the fact that mice have a different antibodies repertoire than humans, and the technology for making antibodies optimizes the selection of relevant B cells via harvesting approach, immunization timing and screening platform.
About Tonix Pharmaceuticals
Founded in 2007, Tonix Pharmaceuticals is a clinical-stage biopharmaceutical firm committed to finding, acquiring, licensing, and developing therapies for the treatment and prevention of diseases and the alleviation of human suffering. Its pipeline is focused on rare diseases, immunology, infectious diseases, and central nervous system (CNS) product candidates. The company's immunology portfolio consists of biologics for the treatment of organ transplant rejection, cancer and autoimmunity. At the same time, its infectious disease portfolio includes next-generation COVID-19 vaccines and vaccinations against smallpox and monkeypox.
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