US Specialty Formulations
USSF is a leading cGMP pharmaceutical manufacturer dedicated to providing high-quality clinical materials, vaccines, and pharmaceutical solutions. Founded in 2013, the company specializes in vaccine development, formulation, and manufacturing, including innovative oral COVID-19 vaccines, with a focus on regulatory compliance, advanced technologies, and collaborative partnerships to advance global healthcare.
Industries
Nr. of Employees
small (1-50)
US Specialty Formulations
Bethlehem, Pennsylvania, United States, North America
Products
Oral mucosal COVID-19 vaccine candidate (clinical-stage)
Oral/mucosal vaccine formulation developed for SARS-CoV-2 reported to have completed Phase I human safety testing and demonstrated thermal stability.
Vaccine candidates (pre-clinical: Group A Strep, Pertussis)
Vaccine candidates for Group A Streptococcus and pertussis developed as oral/mucosal formulations in pre-clinical stages.
Botanical pharmaceutical-grade extracts
Pharmaceutical-grade botanical extracts manufactured under cGMP for use in formulations.
Small molecule formulations and custom formulations
Contract-manufactured small molecule formulations and bespoke custom formulations for clinical and commercial needs.
Clinical and pre-clinical supplies for IND studies
cGMP clinical supplies produced to support investigational studies, including packaging and label services for clinical trial use.
Oral mucosal COVID-19 vaccine candidate (clinical-stage)
Oral/mucosal vaccine formulation developed for SARS-CoV-2 reported to have completed Phase I human safety testing and demonstrated thermal stability.
Vaccine candidates (pre-clinical: Group A Strep, Pertussis)
Vaccine candidates for Group A Streptococcus and pertussis developed as oral/mucosal formulations in pre-clinical stages.
Botanical pharmaceutical-grade extracts
Pharmaceutical-grade botanical extracts manufactured under cGMP for use in formulations.
Small molecule formulations and custom formulations
Contract-manufactured small molecule formulations and bespoke custom formulations for clinical and commercial needs.
Clinical and pre-clinical supplies for IND studies
cGMP clinical supplies produced to support investigational studies, including packaging and label services for clinical trial use.
Services
Formulation development and scale-up
End-to-end formulation design, method analysis and scale-up from lab to clinical/commercial production.
Analytical development and QC testing
Analytical method development, stability testing and quality control for clinical and commercial materials.
Fermentation and purification services
Upstream fermentation and downstream purification of biologic intermediates.
Formulation and fill services (fill–finish)
Advanced formulation and fill services including single-use and semi-automated filling for vials, syringes and IV bags.
cGMP materials for vaccine manufacturing
Production of clinical-grade vaccine materials and adjuvants for pre-clinical and human trials (Phase I/II).
Stability programs
Design and execution of stability studies to define storage conditions and shelf-life, including high-temperature stability assessments.
Formulation development and scale-up
End-to-end formulation design, method analysis and scale-up from lab to clinical/commercial production.
Analytical development and QC testing
Analytical method development, stability testing and quality control for clinical and commercial materials.
Fermentation and purification services
Upstream fermentation and downstream purification of biologic intermediates.
Formulation and fill services (fill–finish)
Advanced formulation and fill services including single-use and semi-automated filling for vials, syringes and IV bags.
cGMP materials for vaccine manufacturing
Production of clinical-grade vaccine materials and adjuvants for pre-clinical and human trials (Phase I/II).
Stability programs
Design and execution of stability studies to define storage conditions and shelf-life, including high-temperature stability assessments.
Expertise Areas
- cGMP sterile and aseptic manufacturing
- Oral and mucosal vaccine development
- Formulation development and scale-up
- Clinical and pre-clinical materials production for INDs
Key Technologies
- Oral mucosal vaccine delivery platforms
- Aseptic fill–finish with isolator systems
- Single-use and semi-automated filling systems
- Fermentation and downstream purification