What we do

Aid in formulation development activities dedicated to pre-clinical through licensed products for:

  • mono- or multi-valent bacterial or viral antigen formulations,
  • vaccine combinations,
  • live attenuated vaccines.

Assist implementation of ICH Q8 to increase the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.

All other activities associated with development projects such as preparation of technical reports, scientific manuscripts, and invention disclosure memos.

Review, preparation for filing or prosecution of patents, as well as scientific publication writing.

Our competitive edge is the broad experience and scientific expertise we have in vaccine formulations for the manufacturing of pre-clinical and clinical lots, under GLP/GMP recommendations.

We have experience developing formulations with a variety of vaccine targets: Anthrax, HepatitisB, Botulinum neurotoxinA, Clostridium difficile toxoids, Meningococcal conjugates, Meningococcal recombinant proteins, Combination vaccines (DTaP, HepB, IPV, Hib), Plague (recombinant F1-V), Pneumococcal conjugates, H1N1 pandemic split virus, Pneumococcal recombinant proteins, H5N1 pandemic split virus, Seasonal flu, Staphylococcal enterotoxin B

  • Stability:
    Identification of stability indicating assays, correlation of real time and accelerated conditions for shelf life predictions, impact of temperature excursions during storage.
  • Adjuvantation:
    Global expert in formulation with aluminum adjuvants, Experienced with manufacturing and formulation of emulsion adjuvants, Experienced with alternative adjuvants such as Toll-like receptor agonists.
  • Stabilization (liquid and freeze-dry):
    Determination of optimal stabilizers to maintain stability of the antigen(s) in the desired presentation for the shelf life of the product.