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, PHARMACY MARKET
VERO Biotech | February 03, 2023
On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution.
GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow.
The following are the expected advantages of the second generation GENOSYL® DS
Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture).
Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost.
Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds.
Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment.
It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023.
About VERO Biotech
Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.
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BUSINESS INSIGHTS, PHARMA TECH
Avacta | January 23, 2023
Avacta Group plc, a leading life sciences company focused on developing innovative, targeted oncology medicines and powerful diagnostics, recently announced that AVA6000 has maintained a very favorable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial. Furthermore, analysis of tumor samples acquired from six patients across multiple cohorts shows that doxorubicin is being released within the tumor tissue, supporting the pre|CISIONTM technology's tumor-targeting capability.
Patients in cohort 4 continue to tolerate AVA6000 well, with a significant decrease in the occurrence and severity of the commonly associated toxicities with the administration of traditional doxorubicin treatment. Nausea, vomiting, Alopecia, mucositis, myelosuppression, and cardiotoxicity are all among the typical toxicities. Notably, the typical drug-related cardiotoxicity of doxorubicin was not found even at the highest dosage levels in group 4, equivalent to more than double the standard dose of doxorubicin.
In order to confirm the release of the active chemotherapy, doxorubicin, in tumor tissue, several tumor biopsies acquired from patients in different cohorts have been analyzed. This analysis demonstrates that AVA6000 targets the release of doxorubicin to tumor tissue at therapeutic levels that are significantly higher than those detected in the bloodstream at the same time point.
To date, AVA6000 has been administered to 19 patients with advanced and/or metastatic solid tumors who were enrolled across four groups. Based on the very favorable safety profile of AVA6000 in the study thus far, the Safety Data Monitoring Committee (SDMC) has recommended that the study be extended to higher dose cohorts in order to identify a maximum tolerated dose (MTD) required to inform dosing levels for the phase 1b and future studies. The Company anticipates completing these additional cohorts within the first half of 2023.
About Avacta
Avacta is a healthcare group that promotes human health and well-being by creating new cancer treatments and powerful in vitro diagnostics. Its mission is to create the future of medicine by producing safe and effective medications as well as high-performance diagnostics using its unique Affimer® and pre|CISIONᵀᴹ platforms. By merging these two platforms, the Company is constructing a pipeline of innovative cancer therapeutics to fulfil its goal of developing successful treatments for all cancer patients, including those who do not react to current immunotherapies.
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