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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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