Singota Solutions is a Contract Development and Manufacturing Organization (CDMO) focused on moving products through the drug development pipeline faster—with agility, accountability, and transparency. Our goal is to collaborate with our clients and provide customized services to meet their needs and hit their milestones faster.
Our gloveless, robotic aseptic filling workcell provides a state-of-the-art filling process for manufacturing injectable therapies into vials, syringes, or cartridges. Advantages of our aseptic filling service include rapid access to our line with standard, ready-to-use components and the potential to reduce line losses as compared to traditional manufacturing capabilities. Singota also provides customized solutions for formulation development, supply chain/materials management, analytical testing, and finishing services.
Singota’s shorter lead times, dedicated team of experts, and single site location mean your project will receive focus and speed while never compromising quality, whether you are a virtual or large pharmaceutical company.
4320 W Zenith Drive
Bloomington, IN 47404
Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug product. This article is the first in a series that describes some of the challenges and solutions available to pharmaceutical/biotech companies and their supply chain partners in the CDMO realm to ensure that critical clinical supply materials are ready when they are needed and how one CDMO, Singota Solutions, has positioned itself to meet these challenges.
A small, research-focused biotechnology company received incredibly positive results in the clinic for their current program and was instructed by leadership to push ahead quickly with an aseptic fill for another trial. They urgently needed help to get their finished drug product clinical supplies to their distributor by December to make it in the clinic by January 2020.
Dealing with contract development and manufacturing organizations (CDMOs) can be a daunting task for some drug developers. Here are five key factors to keep in mind when trying to troubleshoot drug development delays by selecting the right CMO.
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Learn how perform various risk assessments to adequately determine the level of control required to ensure the safe transport of products throughout the pharmaceutical supply chain.
If you’re struggling to achieve legitimate value, take advantage of this 3-step process to strengthen your supply chain partnerships.
Supply chain visibility is paramount, but what criteria should be considered when evaluating monitoring devices whose data can be accessed from the provider’s software platform in real-time?
Once you have successfully encapsulated an (API), the next task is to characterize that product and understand its release kinetics, such that it can be labeled and prepared for subsequent studies. Following are some lessons learned from characterizing the end product.
The emulsion system created when forming microparticle can quickly become complex. Following are critical factors to consider when beginning work with microparticle formulation for a large protein molecule.
When an employee performs a wide range of manufacturing tasks, both in and beyond his or her comfort zone, there is less likelihood of burnout.
Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow client access to data.
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.