Singota Solutions
4320 W. Zenith Drive
Bloomington, IN 47404
T: (812) 961-1700
E: solutions@singota.com
W: www.singota.com

Singota Solutions is a contract development and manufacturing organization (CDMO) focused on getting products to patients faster by being agile, accountable, and transparent. Founded in 2006, and headquartered in Bloomington, Indiana, Singota provides responsive, quality driven outsourcing services.

Aseptic Manufacturing – Singota fills parenterals into ready-to-use vials, syringes, or cartridges utilizing our gloveless, robotic, SA25 aseptic filling workcell for pre-clinical, clinical, and small commercial therapies. Our manufacturing process ensures freedom from in-process human intervention by not only removing the impact of operators from the initial aseptic environment but also by removing operator variability from the filling process. Some features include:

• Precise, automated, robotic filling allowing repeatability and reduced line loss
• Small volume runs for vials, syringes, or cartridges
• Use of pre-sterilized, nested containers, and pre-sterilized, single use product contact materials
• Customized finishing services, specializing in small-volume clinical batches

Quality Control & Development Laboratory – Our laboratory services include formulation development, process development, and analytical testing. We work with clients in the early phases of development to post-manufacturing support. Our on-site lab saves valuable time on client projects by working seamlessly with our comprehensive services to ensure client milestones are met. Services include:

• Technology/method transfer
• Method qualification
• Thermal characterization
• Lyophilization
• Microbiology challenge studies
• Raw material testing—compendial and other QC release test methods for identity and CoAs
• Release and stability testing (ICH)
• Transport simulation testing, thermal cycling, and thermal excursion studies
• Material compatibility
• Forced degradation studies
• Regulatory support for IND submissions
• Solubility and stability formulation enhancements

Supply Chain Management & Warehousing – Singota manages a diversified group of materials from APIs and excipients to finished products in our secure cGMP warehouse. We have the capability to handle toxic, potent, flammable, and hazardous materials. Service features include:

• Controlled room temperature (15°C-25°C), cool (2°C-8°C), and frozen (-20°C, and -80°C) storage conditions available
• Clinical trial support and material distribution
• Expertise in temperature-controlled materials management and distribution practices
• Sampling and dispensing capabilities for bulk material forms (liquids, powders, tablets)
• Client accessible material management software
• International supply chain assistance including importer of record services and European storage

Contact us at solutions@singota.com or (812) 961-1700 to speak with a Business Development representative to see how we can accelerate your project.

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