Singota Solutions, a pharmaceutical contract development and manufacturing organization, can provide benefit to clients through increased testing capabilities.
Bloomington, IN (June 21, 2018)–Singota Solutions has been certified as an analytical laboratory qualified for release testing of Captisol. The qualification will benefit Singota’s clients, especially pharmaceutical firms at clinical trial and commercial stages looking to solubilize or stabilize their drug product and improve characteristics of their formulations.
Captisol is a Ligand Pharmaceuticals product consisting of uniquely modified cyclodextrin. The unique design enables the creation of new products by significantly improving solubility, stability, bioavailability, and dosing of many types of active pharmaceutical ingredients (APIs).
Singota worked closely with Ligand to establish a protocol to execute a method verification for the Compendial testing of Betadex Sulfobutyl Ether Sodium (Captisol), per the USP-NF monograph. The first lots of Captisol successfully completed their analysis and release testing in July 2017.
Singota’s laboratory focuses on formulation development and analytical testing. In addition, the company also provides the pharmaceutical industry with state-of-the-art robotic aseptic manufacturing, especially suited for small volume fills in the pre-clinical, early clinical, and small population commercial therapeutic segments.
For more information, please contact Singota – email@example.com or 812.961.1700.
About Singota Solutions
Singota Solutions is a contract development and manufacturing organization focused on moving products through the development pipeline faster—with agility, accountability, and transparency. Founded in 2006, the company is a woman-owned business operating in Bloomington, Indiana. Singota’s gloveless, robotic aseptic filling service is ideally suited for the production of clinical and niche commercial injectable products in vial, syringe, and cartridges formats. Singota also provides customized solutions for formulation development, supply chain & materials management, analytical testing, and labeling & kitting services. For more information, please visit www.singota.com.
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s Kyprolis®, Baxter International’s Nexterone®, Spectrum’s EVOMELA® and Melinta Therapeutics’ Baxdela™. There are many Captisol-enabled products currently in various stages of development.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. We have a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly.