2021 Year in Review
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In 2021, you did incredible things — and we are grateful to have been part of your journey. Virpax Announces Clinical Trial Site in Canada for First in Human Study of Epoladerm™ for Pain Associated with Osteoarthritis of the KneeProactive Investors: Emyria's Ultra-Pure CBD Capsule Outperforms TGA-Approved CBD Treatment in Pre-Clinical Animal TrialDrug Discovery World: Pharmacokinetic Study for Developing Kidney Disease and Injury TherapiesAltasciences Chosen by Respira Technologies, Inc. as Drug Product Manufacturing Partner for the World’s First Inhaled Nicotine Replacement Therapy (NRT)Laval, Quebec, December 14, 2021 – Altasciences’ pharmaceutical contract manufacturing site in Philadelphia, PA, has been chosen by Respira Technologies, Inc. to manufacture proprietary drug products for the world’s first inhaled smoking cessation therapy. This treatment uses RespiRx™, a vibrating mesh nebulizer (VMN) with a maintenance-free disposable cartridge that reduces and potentially eliminates the risk of patient misuse and non-compliance. Following a successful Pre-Investigational New Drug (IND) meeting with the Food and Drug Administration (FDA) on November 18, Respira is intending to submit their IND application in 2022 under the 505(b)(2) regulatory pathway. Respira also plans to create a larger platform approach for active pharmaceutical ingredient (API) delivery, taking advantage of the multi-drug capabilities of their proprietary platform drug delivery system. To date, 91 potential APIs have been identified. “Our team chooses best-in-class partners, and working with Altasciences has been a great experience overall. Altasciences is playing a big role in advancing Respira’s ambition to secure the FDA’s authorization on a potential breakthrough drug product, and through this collaborative environment, we can change the world of drug development. Altasciences is agile, flexible, and quick, while providing the proven expertise and capability required for cGMP pharma drug product manufacturing. We are thankful for their fast response rate, creativity, and ability to take on the needs of nimble start-ups like Respira,” said Mario Danek, Founder and CEO at Respira Technologies, Inc. Altasciences leverages deep expertise in formulation, development, and manufacturing, as well as flexible processes and significant investments in state-of-the-art technologies, to support clients in their research and commercial manufacturing requirements. “We are delighted to be partnering with Respira Technologies, Inc. on this new and exciting technology. Our team has truly enjoyed having the opportunity to work with a world-class organization that quickly makes key decisions to ensure we meet accelerated timelines,” stated Ben Reed, Executive Vice President of Operations at Altasciences. More information on Respira Technologies, Inc.’s program can be found here. About Altasciences Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. Julie-Ann Cabana Four Reasons to Choose Altasciences as Your Flow Cytometry Partner
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Altasciences offers specialized services in flow cytometry, a highly sensitive system Contract Pharma: XORTX Selects Altasciences to Conduct Pharmacokinetic Bridging StudyAltasciences Chosen by XORTX Therapeutics, Inc. to Conduct Pharmacokinetic Bridging Study XRX-OXY-101 in Support of Developing New Therapies for Progressive Kidney Disease and Acute Kidney InjuryLaval, Quebec, December 9, 2021 – Altasciences is pleased to have been chosen by XORTX Therapeutics, Inc. to conduct a pharmacokinetic bridging study in support of the XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury associated with COVID-19. XORTX’s novel, proprietary formulations of xanthine oxidase inhibitors are aimed at reducing uric acid levels in order to slow the progression of the genetic disorder ADPKD, and protect against acute kidney injury following COVID-19 infection. The first of several clinical trials to characterize XORTX’s novel, proprietary formulations of xanthine oxidase inhibitors, its purpose is to determine whether the increased bioavailability of oxypurinol demonstrated for this formulation in preclinical studies will be replicated in humans. “With a pressing need for better therapeutic options and a global prevalence of kidney disease, we are proud to partner with XORTX for such an important study. We look forward to supporting this innovative company in their goal of bringing a valuable new treatment to the next stage, and getting better drugs to the people who need them, faster,” stated Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences. Altasciences offers a seamless drug development solution that allows sponsors to work with a single, integrated CRO/CDMO in support of early-phase research, from lead candidate selection to preclinical testing to clinical proof of concept in the most time- and cost-efficient way possible. About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. Julie-Ann Cabana
ISSUE NO. 21 — Terminal Sterilization of Pharmaceutical Products
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 In the human health field, injectable medications, ophthalmic preparations, irrigation fluids, dialysis solutions, sutures and ligatures, implants, and certain surgical dressings, as well as the instruments necessary for their use or administration, must be presented in a sterile condition. USP <797> states: “Medications that are required to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine).” There is a growing demand for sterilization of small-molecule parenteral products, including heart medications, eye drops, analgesics, and antibiotics, as well as common intravenous solutions such as glucose, potassium, and saline. Many such products are used by medical professionals in hospitals, and to ensure patient safety, the drug products and related instruments and materials are sterilized at manufacture. This ensures there are no microbial contaminants like fungi or bacteria present when the product is used. In Issue 21 of The Altascientist, we review:
Terminal Versus Aseptic Sterilization for Pharmaceutical ProductsGenerally, regulatory agencies such as the FDA, EMA, among others, prefer terminal sterilization over aseptic, as it provides a high level of sterility assurance. With terminal sterilization, most drug products are produced by mixing the ingredients to form the bulk drug product solution. The bulk product is filled into a tightly sealed container and the entire container is sterilized. Terminal sterilization also offers time savings and cost advantages to pharmaceutical companies. Since terminal sterilization takes place after the formulation and filling steps, these initial manufacturing processes can occur in a less rigidly structured environment, which lowers the complexity, increases the speed, and therefore positively impacts the cost of manufacturing. When terminal sterilization is not an option, aseptic processing is used. Each component (drug, container, closure, etc.) is individually sterilized first, then carefully assembled in a dedicated clean room with a highly controlled environment to make the finished drug product in a manner that prevents contamination. Containers, closures, and filling materials go through their own validated sterilization cycles. Aseptic processing cannot provide the same quantitative level of sterility assurance as terminal sterilization, but it features several layers of control to minimize the risk of contamination. Why Terminal Sterilization is the Ideal Choice for Pharmaceutical ProductsTerminal sterilization is the preferred method for drug products because sterilization takes place after the product has been filled into the primary packaging, thus severely limiting further opportunities for contamination due to human intervention. The process is reliable, repeatable, and delivers an excellent quality product. Terminal sterilization is also less complex, less costly, and more easily reproducible than aseptic processing. When conducted by well-trained, knowledgeable experts, sterilization conditions can be adapted to ensure they are appropriate to the drug product in question, and deliver the robust, thorough sterility results expected from this type of process. In Altasciences’ Grade C suites, we develop injectable drug products and topical ophthalmic preparations that can be terminally sterilized after manufacture. All such drug processing is conducted in our Grade C, cGMP facility, which has been inspected by both the FDA and the European Union Quality Personnel. Our team will guide you in the selection, method development and validation, and final delivery of fully sterilized product. We have decades of experience as a CDMO, and will ensure the efficient, effective implementation of the most appropriate sterilization method for your drug products.
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