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Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1 Trial

Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon, Nathaniel Macapagal, Pam Bruce-Staskal, Christina Fiaschetti and Darryl B. Sampey. Clinical Pharmacology in Drug Development.  July 2023. BioFactura has developed a proposed biosimilar candidate (BFI-751) to ustekinumab reference product. Results are reported for the first-in-human trial designed to compare the pharmacokinetic profiles, safety, and immunogenicity of BFI-751 and … Continue reading

July 24, 2023 Publications

Intranasal monkeypox marmoset model: Prophylactic antibody treatment provides benefit against severe monkeypox virus disease

Eric M. Mucker, Suzanne E. Wollen-Roberts, Adrienne Kimmel, Josh Shamblin, Darryl Sampey and Jay W. Hooper. PLOS Neglected Tropical Diseases.  June 2018. Concerns regarding outbreaks of human monkeypox or the potential reintroduction of smallpox into an immunological naïve population have prompted the development of animal models and countermeasures. Here we present a marmoset model of monkeypox and smallpox disease utilizing a … Continue reading

June 23, 2018 Publications

Enhanced expression of a biosimilar monoclonal antibody with a novel NS0 platform

Darryl Sampey, Pascal Courville, David Acree, Jeffrey Hausfeld and William E. Bentley.  Biotechnology Progress.  January 2018. The precise product quality and lower cost of goods demands of the growing biosimilars industry are driving biomanufacturing innovation. Biosimilar cell lines that produce complex glycoproteins such as monoclonal antibodies must be both highly productive and express a product … Continue reading

January 13, 2018 Publications

Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 1

Simran J. Kaur, Darryl Sampey, Lester W. Schultheis, Leonard P. Freedman and William E. Bentley.  BioProcess International.  October 2016. Biosimilars are biologically derived pharmaceuticals intended to have clinical similarity to a legally marketed innovator product when that product’s patent or market exclusivity has expired. By contrast with generic small-molecule drugs, clinical performance of a biologic … Continue reading

October 14, 2016 Publications
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