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Home About us Services Contact us Upcoming Events Lyophilization Publications Tech transfer Our Customers Exp. Design Biochemical Analysis Case study 1 Case study 2 Case study 3 Case study 4 Case study 5 Solid-state structure JOBS Case Study 1. Development of a multivalent vaccine (current ongoing project) Client Profile DynPort Vaccine Company LLC (DVC), a biopharmaceutical company focused on the development of biodefense biologics products. Products in development at DVC include vaccines for botulinum neurotoxin, tularemia, Venezuelan equine encephalitis, anthrax and plague, and a therapeutic blood product, vaccinia immune globulin, to treat complications of smallpox vaccination. Business Need National Institute of Allergy and Infectious Diseases announced an $11 million grant to the DynPort Vaccine Company for fast-track development of two botulinum vaccines. The grant covers development of a pentavalent vaccine covering botulinum neurotoxin serotypes A, B, C, E, and F, and a heptavalent vaccine covering serotypes D and G. Botulinum toxin is generally accepted as the deadliest naturally occurring substance known. Technical Challenge Seven botulinum antigen proteins require detailed preformulation/formulation development and characterization. Binding to the adjuvant needs to be optimized in a formulation space that accomodates all seven proteins that have different biochemical properties. Multivalent vaccines of the serotypes need to be formulated in a stable formulation and evaluated for potency and efficacy at one of the partnership's sites. HTD Services As five different partnership sites are involved in this project, HTD has established fluid communication systems so that information and data is dessiminated seamlessly between our partners. HTD has been working closely with the purification team at University of Nebraska (Lincoln) bioprocess facility to identify stable formulations for the bulk APIs. With the University of Colorado at Health Sciences Center (Denver) and Engineering Department (Boulder), we have been involved in cutting-edge research on vaccine characterization and bioprocessing of stable vaccine formulations. We have developed a high throughput approach to rapidly identify stabilizing conditions for the seven proteins as they become available and optimize binding of the protein antigens to the adjuvant. The vaccines are characterized by a number of biochemical and biophysical techniques and tested for potency in an animal model. A Product Target Profile (PTP) has been finalized with our client so that there is a clearly defined drug product that the formulation scientist can develop. We have successful prepared and characterized a number of vaccine formulations and evaluated their potencies. Results HTD has delivered the appropriate vaccine formulations according to the fast-track developmental timeline of the project and helped the purification team in formulating a stable API formulation of the purified protein antigens.

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