About Us
Our History Since 2014 Trust Built on Performance
Trust Built on Performance
US Specialty Formulations LLC (USSF) is a thriving biotech and pharmaceutical facility. Today, the 41,000-square-foot manufacturing facility spans over two acres and has become a hub of experts creating diverse solutions, applications and approaches to help clients overcome hurdles in drug discovery and development. USSF provides clinical materials for several clinical trials being conducted both in the USA and abroad.
QYNDR, a vaccine technology offering from (USSF) is a cGMP pharmaceutical manufacturing company, based out of Allentown, PA.
QYNDR is an oral liquid dose vaccine delivery platform. We focus on proprietary NextGen Vaccines, including development of two versions of the SARS-CoV-2. Two formats, G1 oral liquid and G2 capsule oral formats. USSF also engages in collaborations applying the QYNDR technology to target specific diseases. The vaccine is being developed in partnership with VaxForm LLC, a vaccine development company, from an alliance formed in the Ben Franklin TechVentures, Bethlehem, PA.
Current NDA Experience
- Sponsored Human clinical Phase I trial for Oral Covid Vaccine (Completed)
- Providing clinical contracted materials and CMC (Chemistry Manufacturing controls) support for 11 human clinical trials
Uniquely versatile oral vaccination delivery platform
USSF has developed a uniquely versatile method by which Antigen and molecule targeting gut associated lymphoid tissue (GALT) are attached to delivery particles.
2014
Founders built and qualified 1st cleanroom suite
2015
Provided 1st GMP materials for sale to USA market
2015
Provided 1st contract for GMP materials for toxicology lots for client
2016
Secured 1st contract for clinical materials for human Phase I clinical trial
QYNDR Leadership Team
Kyle Flanigan, PhD
CEO, Co-Founder
With more than 25 years of experience, Dr. Kyle Flanigan, Co-founder and CEO of US Specialty Formulations LLC (USSF), is an expert in all pharmaceutical and medical performance materials development stages. He consults with several companies, providing robust and stable solutions and services for formulation, scale-up technology, contingency planning, supply-chain issues, quality systems implementation and new facility design. He brings this knowledge and guidance to USSF’s manufacturing and development teams enabling their clients’ and their pharmaceutical and medical developments on the best path to market.
Dr. Flanigan's latest project is QYNDR, a drinkable oral COVID-19 vaccine that promises to be easier to use, longer lasting and with fewer side effects. He has the expertise and equipment to bring a safe, accessible mucosal COVID-19 vaccine to market.
Garry Morefield, PhD
COO, Co-Founder
As the founder of VaxForm LLC., and Co-Founder of US Specialty Formulations LLC., Dr. Morefield has over 20 years of experience with all stages of development and production in the pharmaceuticals and biologics industry.
He has served as the Deputy Director Formulation and Stability, at Sanofi-Pasteur Inc. He has worked on numerous Disease targets, such as Group A Strep; Covid-19; Pertussis; Group B Strep; Meningococcus; Influenza, C. Difficle; Hepatitis B; Rabies; Diphtheria; Tetanus; S. Aureus; HIV; Anthrax, Plague, Botulinum toxin and combination products.
Dr. Morefield has been closely involved in various industrial collaborations that have led to breakthrough innovations with Sanofi Pasteur; Pfizer; Astellas; Janssen; Serum Institute of India; Lundbeck; Affinivax; and Advanced Bioscience Laboratories (ABL).
Professional Staff
Kyle Flanigan, PhD
Garry Morefield, PhD
COO, Co-Founder
