US Specialty Formulations (USSF) develops custom formulations for sterile injectable pharmaceuticals and oral-mucosal vaccines, focusing on regulatory-compliant clinical materials for vaccine development. The company addresses the need for effective vaccine solutions against viruses like SARS-CoV-2 and Group A Streptococcus, facilitating the timely delivery of safe and effective treatments to healthcare providers.
Funding
$75K raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Developing sterile injectable pharmaceuticals and oral-mucosal vaccines requires specialized formulation expertise and adherence to stringent regulatory requirements, particularly for clinical trial materials. Many pharmaceutical companies lack the in-house capabilities to navigate the complexities of formulation development, analytical testing, and cGMP manufacturing, leading to delays and increased costs.
Solution
US Specialty Formulations (USSF) provides custom formulation and manufacturing services for sterile injectable pharmaceuticals, botanical extracts, and oral-mucosal vaccines, with a focus on producing regulatory-compliant clinical trial materials. USSF guides clients through each phase of product development, from initial method analysis to cGMP commercial formulation. With expertise in research, formulation, analytics, and advanced manufacturing, USSF's scientific team offers tailored solutions that meet compliance standards and optimize the product development journey. The company's capabilities include formulation development, analytical development, fermentation and purification, and formulation and fill services, ensuring a comprehensive approach to pharmaceutical production.
Target Audience
USSF primarily serves pharmaceutical companies, diagnostic firms, and new drug inventors seeking specialized formulation and cGMP manufacturing services for clinical trial materials and commercial products.
Features
- Custom formulation development for sterile injectables, botanical extracts, and oral vaccines
- Analytical development services, including method analysis and validation
- Fermentation and purification capabilities for biologics and vaccine components
- cGMP manufacturing of clinical trial materials, adhering to strict regulatory guidelines
- Formulation and fill services for sterile products
- Expertise in excipient selection and optimization for drug stability and delivery
- Support for investigational new drug (IND) applications and other regulatory submissions