LFB USA
LFB USA is a globalized biopharmaceutical company dedicated to developing and providing innovative pharmaceutical bioproducts for patients with serious and rare diseases. Rooted in science and driven to meet unmet medical needs, LFB USA leverages its proprietary rPRO Technology™ to develop life-changing therapeutics, including a recombinant form of human Factor VIIa. The company offers a full spectrum of services from research to commercialization, fostering partnerships and advancing medical care worldwide.
Industries
Nr. of Employees
medium (51-250)
Products
Recombinant activated coagulation Factor VIIa (development program)
A recombinant analog of human Factor VIIa developed via transgenic-animal expression for treatment and control of bleeding episodes in adolescent and adult patients with hemophilia A or B with inhibitors; supported by Phase II/III clinical programs and regulatory filings.
Human plasma-derived fibrinogen concentrate (development/portfolio)
Plasma-derived factor I (fibrinogen) concentrate developed for treatment of congenital and acquired hypofibrinogenemia.
Intravenous immunoglobulin (IVIG) plasma-protein therapies
Plasma-derived polyvalent IgG replacement therapy for immune deficient patients and high-dose IVIG for certain autoimmune conditions.
Plasma-free antithrombin concentrate (transgenic-derived product)
A transgenic-derived antithrombin product produced without plasma sources, developed via the transgenic production platform and previously progressed to regulatory approval.
Recombinant activated coagulation Factor VIIa (development program)
A recombinant analog of human Factor VIIa developed via transgenic-animal expression for treatment and control of bleeding episodes in adolescent and adult patients with hemophilia A or B with inhibitors; supported by Phase II/III clinical programs and regulatory filings.
Human plasma-derived fibrinogen concentrate (development/portfolio)
Plasma-derived factor I (fibrinogen) concentrate developed for treatment of congenital and acquired hypofibrinogenemia.
Intravenous immunoglobulin (IVIG) plasma-protein therapies
Plasma-derived polyvalent IgG replacement therapy for immune deficient patients and high-dose IVIG for certain autoimmune conditions.
Plasma-free antithrombin concentrate (transgenic-derived product)
A transgenic-derived antithrombin product produced without plasma sources, developed via the transgenic production platform and previously progressed to regulatory approval.
Services
End-to-end development and commercialization services for recombinant proteins
Research through commercialization services including development, clinical support, regulatory strategy, quality systems and manufacturing support for recombinant protein therapeutics.
Transgenic-based manufacturing services
Upstream production in transgenic mammals and associated farm and veterinary operations to produce recombinant therapeutic proteins for clinical and commercial supply.
Clinical development and regulatory filing support
Design and conduct of multicenter clinical trials, dose-ranging and registrational studies, and preparation/submission of regulatory dossiers to health authorities.
End-to-end development and commercialization services for recombinant proteins
Research through commercialization services including development, clinical support, regulatory strategy, quality systems and manufacturing support for recombinant protein therapeutics.
Transgenic-based manufacturing services
Upstream production in transgenic mammals and associated farm and veterinary operations to produce recombinant therapeutic proteins for clinical and commercial supply.
Clinical development and regulatory filing support
Design and conduct of multicenter clinical trials, dose-ranging and registrational studies, and preparation/submission of regulatory dossiers to health authorities.
Expertise Areas
- Therapeutic protein development
- Transgenic animal bioproduction
- Hemostasis therapeutics (bleeding disorders)
- Clinical trial management for biologics
Key Technologies
- Transgenic animal expression systems
- Recombinant DNA expression constructs
- Milk-based protein expression
- Scalable bioprocessing (g to kg scale)