Our mission is to provide high quality, boutique pharmaceutical solutions to healthcare, diagnostic and new drug inventors so that they may help to make the world more comfortable to live in. From method analysis to cGMP commercial formulation, USSF guides you seamlessly through each phase of product development to bring your product to market successfully.
Our ability to provide a multi-faceted approach to formulation and cGMP compliance is of critical value to our customers as there are many unknowns through all the stages of the product development process. With extensive experience in research, formulation, analytics and advanced manufacturing, our world-class scientific team understands the challenges and complexities of providing regulatory conforming clinical materials.
The SARS-CoV2 pandemic highlighted the need for proven and effective approaches to vaccine development. It is important to note that USSF has been working in partnership with Vaxform to develop vaccines since its inception in 2013.
USSF Vaccine Products
Allentown, PA, May 25, 2021 — US Specialty Formulations (USSF), a cGMP pharmaceutical manufacturer, and VaxForm, a vaccine development company, announced positive results from pre-clinical safety and immunological studies for their oral-dosage COVID-19 vaccine, demonstrating the formulation is safe to proceed to human clinical trials.Read More
At US Specialty Formulations (USSF), we take immense pride in our ability to provide a multi-faceted approach to formulation and cGMP compliance, catering to the diverse needs of our esteemed customers. As a leading player in the pharmaceutical industry, we understand that the product development process can be riddled with uncertainties at every stage. To address these challenges effectively, we have expanded our capabilities to include the provision of clinical materials for specialty formulations, including adjuvants, fermentation and purification services, botanical pharmaceutical-grade extracts, cGMP materials for vaccine manufacturing, cGMP vaccine adjuvant development, drug formulation services, making us a comprehensive partner for pharmaceutical production companies.
Excipients play a pivotal role in the formulation of pharmaceutical products. These inactive substances are carefully selected and added to the active pharmaceutical ingredient (API) to facilitate various aspects of drug manufacturing and administration. By leveraging excipients strategically, USSF ensures that the final drug product is safe, effective, and can deliver the intended therapeutic benefit.
Our scientific team, which boasts extensive experience in research, formulation, analytics, and advanced manufacturing, recognizes the significance of providing regulatory-conforming clinical materials. We work closely with pharmaceutical production companies to offer tailor-made solutions that meet compliance standards and optimize the product development journey. One of the key advantages of collaborating with USSF is our deep understanding of the complexities of producing clinical materials for specialty formulations. We acknowledge that each pharmaceutical product has unique challenges, whether related to the active pharmaceutical ingredient (API) characteristics, drug delivery mechanisms, stability, or bioavailability.
Our team of experts is well-equipped to navigate these complexities, ensuring that the clinical materials we provide are of the highest quality and suitable for clinical trials. Through our state-of-the-art facilities, we can manufacture clinical materials on both small and large scales, catering to the requirements of pharmaceutical production companies of various sizes. Our advanced manufacturing processes adhere to strict cGMP guidelines, guaranteeing the consistency, safety, and efficacy of the materials produced. We recognize that the success of clinical trials and subsequent commercialization hinges on the reliability and quality of the clinical materials utilized during the initial stages.
To further enhance our ability to provide specialty formulations, we have established strategic partnerships with leading suppliers and technology providers in the industry. These collaborations allow us access to cutting-edge technologies, novel excipients, and advanced analytical tools, enabling us to stay at the forefront of formulation science. By incorporating these innovative elements into our approach, we aim to expedite the formulation development process while ensuring the products meet regulatory standards.
USSF’s commitment to providing high-quality clinical materials for specialty formulations aligns with our vision to improve global healthcare. These materials are the foundation for investigational new drugs (INDs) and other experimental therapeutics during the pre-clinical and clinical stages of drug development. Our clinical materials undergo rigorous testing and quality assurance measures ensuring they meet the strictest regulatory requirements. In addition to our focus on formulation science, our commitment to cGMP compliance remains unwavering. We understand the stringent regulatory requirements imposed by global health authorities and are fully aware of the consequences that non-compliance can have on the drug development process. By integrating compliance considerations into every step of our clinical materials’ production, we ensure that the materials are in full accordance with industry guidelines and regulations.
Pharmaceutical production companies partnering with USSF can expect a seamless and transparent collaboration. Our project management teams are dedicated to keeping clients informed about the progress of their projects, ensuring timelines are met and potential challenges are proactively addressed. This level of communication and engagement instills confidence in our clients, knowing they are in capable hands throughout the development process. Moreover, we recognize that efficient and robust supply chain management is integral to delivering high-quality clinical materials for specialty formulations. By maintaining a well-established network of suppliers and partners, we minimize the risk of delays and disruptions, allowing for the timely delivery of materials and ultimately speeding up the drug development timeline.
At USSF, the journey to pharmaceutical innovation and market success is a collaborative effort. We value our client’s input and actively encourage open dialogue throughout the development process. By understanding each pharmaceutical company’s unique needs and goals, we can tailor our approach to ensure maximum alignment with their objectives. Our multi-faceted approach to formulation and cGMP compliance, complemented by the capability to provide clinical materials for specialty formulations, sets us apart as a leading partner in the pharmaceutical industry. We take pride in advancing cutting-edge treatments and therapies, empowering our clients to bring life-changing products to market.
The USSF stands ready to support pharmaceutical production companies with our comprehensive research, formulation, analytics, and advanced manufacturing expertise. Our ability to provide regulatory-conforming clinical materials for specialty formulations adds another layer of value to our customers. With a team of dedicated professionals and state-of-the-art facilities, we are committed to delivering high-quality products that meet the rigorous standards set by industry and global health authorities. Our team looks forward to forging new partnerships and making significant contributions to the pharmaceutical landscape as we continue to grow. Together, we can shape a healthier, more promising future for patients worldwide.