US Specialty Formulations LLC
US Specialty Formulations (USSF) is a U.S.-based contract development and manufacturing organization providing cGMP-compliant formulation, analytical, and manufacturing services for pharmaceuticals, vaccines, biologics components, and botanical extracts. Services cover pre-clinical and clinical material production through commercial manufacturing, sterile aseptic fill–finish (vials, syringes, IV bags), analytical method development and validation, stability programs, and private-label packaging and serialization.
Industries
N/A
Nr. of Employees
small (1-50)
US Specialty Formulations LLC
Permanent address: 1401 S Albert St, Allentown, PA 18103; Mailing address: 17 S. Commerce Way #20747, Lehigh Valley, PA 18002-0747
Products
Botanical distillate derived from Sarracenia purpurea
A botanical distillate supplied in vial formats; batches undergo testing for consistency and purity intended for use by licensed healthcare professionals.
Oral mucosal vaccine delivery platform
Oral vaccine delivery platform designed to induce mucosal and systemic immunity and enable needle-free administration with scalability for clinical studies.
Sterile IV bag solutions (single and multi-chamber)
Single- and multi-chamber sterile IV bag products and fill services for saline and other sterile solutions with configurable sizes and packaging.
Botanical distillate derived from Sarracenia purpurea
A botanical distillate supplied in vial formats; batches undergo testing for consistency and purity intended for use by licensed healthcare professionals.
Oral mucosal vaccine delivery platform
Oral vaccine delivery platform designed to induce mucosal and systemic immunity and enable needle-free administration with scalability for clinical studies.
Sterile IV bag solutions (single and multi-chamber)
Single- and multi-chamber sterile IV bag products and fill services for saline and other sterile solutions with configurable sizes and packaging.
Services
End-to-end cGMP manufacturing for clinical and commercial pharmaceutical products including sterile injectables, oral liquids, topicals and solid oral dosage forms.
Pre-formulation studies, prototype development, excipient selection and manufacturability optimization to support clinical advancement and technology transfer.
Analytical method development and validation, impurity profiling, endotoxin and particulate testing, dissolution and stability studies to support product characterization and regulatory submissions.
Aseptic filling and packaging services for sterile vials, pre-filled syringes and IV bags (single and multi-chamber) using isolators and ISO-class cleanrooms.
Turnkey private-label packaging with artwork management, tamper-evident and child-resistant closures, and serialization/track-and-trace implementations.
Upstream fermentation and downstream purification processes to generate biologic components used in vaccines and specialty biologics.
End-to-end cGMP manufacturing for clinical and commercial pharmaceutical products including sterile injectables, oral liquids, topicals and solid oral dosage forms.
Pre-formulation studies, prototype development, excipient selection and manufacturability optimization to support clinical advancement and technology transfer.
Analytical method development and validation, impurity profiling, endotoxin and particulate testing, dissolution and stability studies to support product characterization and regulatory submissions.
Aseptic filling and packaging services for sterile vials, pre-filled syringes and IV bags (single and multi-chamber) using isolators and ISO-class cleanrooms.
Turnkey private-label packaging with artwork management, tamper-evident and child-resistant closures, and serialization/track-and-trace implementations.
Upstream fermentation and downstream purification processes to generate biologic components used in vaccines and specialty biologics.
Expertise Areas
- cGMP pharmaceutical manufacturing
- Formulation development and scale-up
- Sterile aseptic processing and fill–finish
- Vaccine and adjuvant development
Key Technologies
- Single-use filling systems
- Semi-automated fill lines
- Oral mucosal vaccine delivery platforms
- Aseptic isolators and ISO-class cleanrooms
News & Updates
Announcement of positive pre-clinical safety and immunological results enabling progression to Phase I human clinical trials for an oral COVID-19 vaccine formulation.
Company press items including announcement of a $15M expansion to modernize biopharma operations and increase production capacity at the Lehigh Valley facility.
Publication notes completion of Phase I clinical trials for an oral vaccine delivered via the oral mucosal platform.
Announcement of a $15 million expansion project to modernize biopharma operations and add clean room suites and packaging equipment.
Announcement of positive pre-clinical safety and immunological results enabling progression to Phase I human clinical trials for an oral COVID-19 vaccine formulation.
Company press items including announcement of a $15M expansion to modernize biopharma operations and increase production capacity at the Lehigh Valley facility.
Publication notes completion of Phase I clinical trials for an oral vaccine delivered via the oral mucosal platform.
Announcement of a $15 million expansion project to modernize biopharma operations and add clean room suites and packaging equipment.