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
1401 S Albert St, Allentown, PA 18103
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
End-to-end formulation design, method analysis and scale-up from lab to clinical/commercial production.
Analytical method development, stability testing and quality control for clinical and commercial materials.
Upstream fermentation and downstream purification of biologic intermediates.
Advanced formulation and fill services including single-use and semi-automated filling for vials, syringes and IV bags.
Production of clinical-grade vaccine materials and adjuvants for pre-clinical and human trials (Phase I/II).
Design and execution of stability studies to define storage conditions and shelf-life, including high-temperature stability assessments.
End-to-end formulation design, method analysis and scale-up from lab to clinical/commercial production.
Analytical method development, stability testing and quality control for clinical and commercial materials.
Upstream fermentation and downstream purification of biologic intermediates.
Advanced formulation and fill services including single-use and semi-automated filling for vials, syringes and IV bags.
Production of clinical-grade vaccine materials and adjuvants for pre-clinical and human trials (Phase I/II).
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
News & Updates
USSF and VaxForm announced positive pre-clinical safety and immunological study results for their oral COVID-19 vaccine, demonstrating safety for human trials.
VaxForm and USSF are among the few companies developing next-generation mucosal COVID-19 vaccines aimed at reducing infection and transmission.
Kyle Flanigan, Ph.D., co-founder and CEO of USSF, discusses the development of an oral, thermo-stable COVID vaccine that is easier to use and with fewer side effects.
USSF is developing an oral COVID-19 vaccine to increase global vaccination rates, currently in clinical trials.
USSF, a biotech startup in Allentown, PA, is working to bring an oral COVID-19 vaccine to market, with Phase 1 trials completed.
Research on mucosal vaccines including oral, nasal, and inhaled vaccines, with USSF developing an oral COVID-19 vaccine.
USSF and VaxForm announced positive pre-clinical safety and immunological study results for their oral COVID-19 vaccine, demonstrating safety for human trials.
VaxForm and USSF are among the few companies developing next-generation mucosal COVID-19 vaccines aimed at reducing infection and transmission.
Kyle Flanigan, Ph.D., co-founder and CEO of USSF, discusses the development of an oral, thermo-stable COVID vaccine that is easier to use and with fewer side effects.
USSF is developing an oral COVID-19 vaccine to increase global vaccination rates, currently in clinical trials.
USSF, a biotech startup in Allentown, PA, is working to bring an oral COVID-19 vaccine to market, with Phase 1 trials completed.
Research on mucosal vaccines including oral, nasal, and inhaled vaccines, with USSF developing an oral COVID-19 vaccine.