BUSINESS INSIGHTS, PHARMA TECH
CONTINUUS Pharmaceuticals | March 15, 2023
On March 14, 2023, ValGenesis, Inc., a leading enterprise validation lifecycle management solutions provider, announced that CONTINUUS Pharmaceuticals has successfully implemented the ValGenesis Validation Lifecycle Management System (VLMS) for efficient management of validation processes across the company in a 100% digital format.
CONTINUUS Pharmaceuticals is a rapidly growing small business specializing in end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals. As a spin-out company resulting from a long-term collaboration between MIT and Novartis, CONTINUUS Pharmaceuticals is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of raw materials and APIs to final dosage forms.
Due to the immense validation requirements involved in the production of different drug products, CONTINUUS Pharmaceuticals needed an electronic solution that determines the disposition of their assets while switching amongst product lines. By leveraging the ValGenesis VLMS, CONTINUUS Pharmaceuticals has successfully implemented facilities, equipment validation, computer system and utility validation.
The ValGenesis VLMS is the system of record for CONTINUUS Pharmaceuticals' engineering team and will be expanded to other teams in the future. The highly automated, real-time, and compliant system provided by ValGenesis minimizes the potential for Good Manufacturing Practice (GMP) non-compliance while accelerating time to market.
About CONTINUUS Pharmaceuticals
CONTINUUS Pharmaceuticals is an end-to-end integrated continuous manufacturing (ICM) company specializing in pharmaceutical production. The company is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of APIs and raw materials to final dosage forms. It leverages a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through a $65 million joint research project between Novartis and MIT. With ICM, it aims to transform and streamline the supply chain of pharmaceuticals by delivering high-quality, lower-cost drugs "on-demand."
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CPD AND LEARNING
Miravo Healthcare | March 16, 2023
Nuvo Pharmaceuticals Inc., which operates as Miravo Healthcare (Miravo), and Searchlight Pharma Inc., a Canadian specialty firm, have recently announced the closing of the previously announced plan of arrangement of Miravo with Searchlight. As per the arrangement terms, Searchlight acquired all the outstanding common shares of Miravo in exchange for $1.35 per share in cash, and the Miravo common shares will be removed from the Toronto Stock Exchange. Miravo will also apply to cease being a reporting issuer in each of the Canadian provinces.
The registered shareholders of Miravo must complete, sign and return the letter of transmittal and share certificate(s) to TSX Trust Company, the depositary, to receive their compensation under the arrangement. Non-registered shareholders will receive their compensation through their intermediary.
Before the Arrangement, Searchlight did not possess any Company Shares. Searchlight bought 11,388,282 Company Shares, representing 100% of the issued and outstanding Company Shares, for $1.35 per Company Share in conjunction with the arrangement.
Searchlight Pharma Inc., President and CEO, Mark Nawacki, commented, "Today marks the beginning of a new chapter for Miravo as it officially combines with Searchlight and continues as a private company." He further emphasized, "Searchlight plus Miravo will be a diversified, large and strong company – based on IQVIA CDH sales data, we will rank in the top three of Canadian specialty pharma companies – and this positions us well to continue to execute our successful business model and to deliver on our leadership objective in the sector. On behalf of the Searchlight team, I express our thanks to all Miravo stakeholders for their cooperation throughout this acquisition process, and I warmly welcome our new Miravo colleagues to the Searchlight family."
(Source – Business Wire)
About Miravo Healthcare
Miravo Healthcare, formerly known as Nuvo Pharmaceuticals Inc., is a Canadian specialty pharmaceutical company that focuses on developing and commercializing innovative therapies. Its mission is to improve patient's quality of life by providing them with safe and effective treatments for chronic conditions such as pain, inflammation, and addiction. Miravo Healthcare's portfolio includes a range of prescription drugs, over-the-counter products, and medical devices used in various therapeutic areas, including pain management, dermatology, and women's health. The company's flagship product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID) used to treat knee osteoarthritis. It is committed to sustainability and social responsibility, and the company's initiatives include reducing its environmental footprint, supporting local communities, and promoting diversity and inclusion. With a focus on innovation and patient care, it continues making significant contributions to the pharmaceutical industry in Canada and beyond.
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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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