Altasciences 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 Injury
Laval, 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
Altasciences
+1 514 601-9763
jcabana@altasciences.com
ISSUE NO. 21 — Terminal Sterilization of Pharmaceutical Products
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:
- the benefits of terminal sterilization over aseptic sterilization
- selecting the best terminal sterilization method for your pharmaceutical product process validation
Terminal Versus Aseptic Sterilization for Pharmaceutical Products
Generally, regulatory agencies such as the FDA, EMA, among others, prefer terminal sterilization over aseptic, as it provides a high level of sterility assurance.
XORTX Therapeutics Appoints Altasciences as CRO for Clinical Study
Globe Newswire: XORTX Therapeutics Appoints Altasciences as CRO for Clinical Study
Up Close and Personal with Dr. Denise Milovan
Neuroscientist Dr.
Psychedelics — Regulatory Environment Challenges
A History of Public Attitude Towards Psychedelic Drugs
Psychedelic drugs exist within a unique social, legal, and historical environment, with roots in the public imag
Driving Simulation – An Indispensable Tool for Clinical Trials
Altasciences Expands Ligand Binding Laboratory to Meet High Demand for Bioanalytical Solutions
Laval, Quebec, November 23, 2021 — Altasciences, a leading drug development solution company, announced today the completion of a second expansion of their ligand binding laboratory to meet the high demand for quality bioanalytical services. The GLP, GCP laboratory was enlarged to include 52 benches for sample analysis, an enhanced space for cell culture and flow cytometry services, additional extraction rooms for handling all types of tissue matrices, a dedicated CL2 room for handling samples and RG2 material, a balance room for critical reagent and solution preparation, and an extraction space for an additional 50 analysts.
“At Altasciences’ One Laboratory Sciences, we accelerate our clients’ programs by seamlessly integrating our new state-of-the-art bioanalytical lab with our preclinical and clinical studies,” added Dr. Lynne Le Sauteur, Vice President, Laboratory Sciences.
With this expansion, Altasciences’ ligand binding assay tripled its square footage and will add to its employee base. Altasciences’ goal is to offer clients the opportunity to leverage the significant knowledge and industry experience of our team of scientific experts to develop strategic bioanalytical testing plans to complement their drug development programs.
“Our growing state-of-the-art laboratory will further expand our breadth of expertise and services for ligand binding assays, cell-based assays, flow cytometry, and other specialty assays to support biologics and oligonucleotide drug development,” says Dr. Danielle Salha, Senior Director, Immunochemistry & Immunology, Ligand Binding Assays.
Altasciences uses innovative and cost-effective approaches to develop or customize ligand binding assays for the quantitative determination of biologics and small-molecule therapeutic products. Altasciences continues to expand its immunogenicity, PK, oligonucleotide, and biomarker testing to its already robust preclinical and clinical study and bioanalysis testing capabilities.
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
Altasciences
+1 514 601-9763
jcabana@altasciences.com