Our Company

US Specialty Formulations LLC (USSF) is a registered Good Manufacturing Practice (cGMP) production manufacturer founded in 2013 to bring state-of-the-art quality processes to pharmaceutical manufacturing.

USSF provides materials and services for:

  • Clinical materials (investigational new drugs)
  • Pre-clinical materials
  • Stability programs
  • Private label formulations and packaging

Formulation development and scale-up

Quality

USSF operates as an FDA registered and monitored outsourced facility manufacturing sterile drugs exclusively. These include but are not limited to:

  • Sterile Vials & Bottles
  • Pre-­filled syringes
  • IV Bags single & Multi-­‐chamber

USSF maintains isolators and clean rooms at the ISO 8, ISO 7 and ISO 5 designations for aseptic production of pharmaceuticals for human use. Batch sizes range from 10 -­‐ 15000 vials with additional capacity available.

Operations are conducted under the FDA Regulations as a 503B Outsourced Facility. Incoming materials, production and release data are rigorously evaluated and controlled. In addition, batch release data is reviewed by a licensed pharmacist prior to release.

Sterile injectable pharmaceuticals with the highest quality production systems:

  • Controlled environment ensures product sterility
  • State-of-the-art paperless electronic manufacturing and batch record control
  • World-class incoming materials management, supply chain and product quality systems
  • Integrated quality and supply systems allow expedited delivery and a secure supply chain
  • Specialty formulations are packaged in syringe, vial and IV bag presentations. All products undergo quality control testing

We are growing. Apply for open positions.

 

Led by Kyle Flanigan, PhD and Garry Morefield, PhD, the USSF team of scientists and experts have created diverse solutions, applications, and approaches to help their clients overcome various challenges related to drug discovery and development. We apply an Agile High Performance Teams system to facilitate efficient collaboration and problem solving to select the best path to get your products to market.

We leverage our proven methods, analytics, scale-up technologies, and technology transfer best practices to guide your complex small compound or vaccine development securely and as efficiently as possible from development through to commercial manufacture.

Kyle Flanigan

PhD, Co-Founder and CEO, brings over 20 years of experience with all development stages of performance materials. He served as the Director Electronic Materials Avantor (Mallinckrodt/Baker), Inc, responsible for Commercialization. He consults with several companies, providing robust and stable solutions and services for formulation, scale-up, contingency planning, supply-chain, quality systems implementation and new facility design.

Dr. Flanigan was the Product Line Manager at Honeywell Electronic Materials, and also served as the Staff Scientist, Technology and Manufacturing Fab Materials, at Intel Corporation.

Garry Morefield

PhD, as COO, is the founder of VaxForm LLC, Co-Founder 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).

USSF cGMP Facilities offer diverse approaches with a state-of-the-art facility, that operate under current good manufacturing practice (cGMP), necessary for compliance with regulatory guidelines. We have vetted, rigorous procedures in place that ensure the regulations are always followed to meet compliance. We offer Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms for conducting cGMP manufacture of sterile injectable products, and Class 10,000 (ISO 7) manufacturing suites for production of oral dosage forms. Our modern facility is qualified to produce Phase I/II clinical trial materials and has self-contained isolators for use with high potency compounds and/or aseptic processing.

We are also about controlling cost when meeting cGMP guidelines, especially during early stage development. Our leadership team, supported by our scientists and experts offer immense knowledge and experience to provide cost saving proof-of-concept applications during early stages of drug discovery and development.

Our expertise and experience with cGMP process also offer realistic timelines and schedules, to help with budgeting and planning. Our best practices enable us to keep to the estimated budgets and committed deadlines, as we are able to anticipate risks and delays, that come at all stages of drug development.

We offer all the essential capabilities required from a cGMP partner – an experienced management team, highly qualified team of scientists and SMEs, advanced technologies, a state-of-the-art facility, proven track record, and most importantly, regulatory compliance.

Living in the Lehigh Valley: Oral COVID-19 Vaccines promises to expand the number of people vaccinated .

April 18, 2022

An Allentown company, U.S. Specialty Formulations, is developing a new oral COVID-19 vaccine that promises to expand the number of people vaccinated around the world. The vaccine is undergoing clinical trials now. Grover Silcox reports.

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Allentown biopharmaceutical firm calls oral COVID-19 vaccine a game changer

March 11, 2022

An Allentown biopharmaceutical firm is making progress on an oral vaccine for the COVID-19 virus that could be a game changer in the fight against the disease.

Kyle Flannigan and Garry Morefield of U.S. Specialty formulations said the ease and safety of the vaccine is what’s needed in the next stage in the fight against COVID-19 in the U.S. and around the globe.

Read More

Kyle Flanigan, CEO and co-founder of U.S. Specialty Formulations, talks about the company Thursday, Feb. 10, 2022, at its facility in Allentown. The biotech company is working to develop an oral COVID vaccine.

Feb 10, 2022

For Kyle Flanigan of Bethlehem, one of few African Americans in a pharmaceutical business leadership position, getting into the field wasn’t a challenge; it was what came afterward. “The challenge for Black people in this industry is recognition and promotion,” said Flanigan, 51, co-founder and chief executive officer of US Specialty Formulations, which makes medications and vaccines.

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Meet The Next Generation Of Black Leaders And Entrepreneurs

Feb 22, 2022

Black entrepreneurship is booming across all industries and these enterprising business owners are smashing barriers, celebrating diversity, and representing the next generation of Black-owned businesses. Endorsed by Soulaima Gourani (Forbes Contributor),

Dr. Kyle Flanigan, Ph.D., co-founder of US Specialty Formulations, LLC, is one of the very few Black owners of a biotech company. Dr. Flanigan’s specialty is in the development and commercialization of medication bringing oral vaccines to market. He is an innovator in vaccines and immunotherapies, small molecule formulations, botanical pharmaceutical-grade extracts, and contract manufacturing.

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Husband of Vice President Kamala Harris Meets with Manufacturers and Business Owners at AEDC’s Bridgeworks Center

May 18, 2021

US Specialty Formulations owner Kyle Flanigan offered remarks about his own challenges supporting employees during the pandemic before discussing his company’s coronavirus vaccine development and rollout. Bridgeworks Incubation Program Manager David Dunn worked closely with Flanigan in securing financing for his company through AEDC’s Urban Made program. Dunn was extremely pleased to see Flanigan as a part of the roundtable discussion.

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December 3, 2020 — Pennsylvania DCED Press Conference

On December 3, 2020, the Pennsylvania Department of Department of Community and Economic Development (DCED) held a zoom press conference to announce expansion of USSF into a new full cGMP manufacturing facility.

Excerpts from the press conference are featured in the video below: