Optimizing Noninvasive Delivery of Biomolecules

Julien Meissonnier (vice president of science and technology, Catalent), BPI Theater @ BIO, June 7, 2016, 2:00–2:20 pm

The Catalent Applied Drug Delivery Institute (CADDI) is an organization that aims to improve comfort for patients and expand the use of advanced noninvasive delivery technologies. The institute was developed in 2012, when Catalent recognized a gap existing between academia and industry when it came to the science of noninvasive delivery. Through it, the company strives to foster the development of new technologies, share knowledge, and promote collaboration among industry leaders, academic experts, customers, and regulators.

The CADDI supports the Noninvasive Macromolecule Delivery Consortium (NMDC), which consists of a group of experts who gather regularly to share knowledge about noninvasive delivery of macromolecules (proteins, peptides, and vaccines). The consortium has four working groups that each consider a different form of noninvasive delivery: oral, pulmonary/nasal, ocular, and transdermal. The NMDC has produced a comprehensive guide on noninvasive delivery methods and will be hosting a four day conference next February about new technologies, science, and deliverables in the field.

When considering noninvasive delivery, you might need to test several methods of administration and drug formulations to find the best one. Absorption is related to biomolecule structure, so companies need to find the right structure to succeed — for example, in passing the dermal or sublingual barriers. In one case, a client first tried a tablet that was swallowed, but the drug was not absorbed into patient’s bodies. Then the Catalent team tried the same drug in a wafer that was dissolved under the tongue and was successful: The drug was absorbed through the sublingual barrier.

Catalent has an integrated offering that can rapidly screen the potential of a biomolecule to be delivered appropriately. Meissonnier presented examples of finding the best delivery method. First, a development team assesses surrogate formulations for their ability to get a biomolecule past different barriers. Once they’ve found the best barrier to target, they reengineer the molecule and develop the most efficacious formulation. Finally, they ensure that the selected method provides the right amount of exposure to deliver the drug.

Further Reading

Breit J, Dubose D. Spray-Dry Manufacture of Vaccine Formulations: Enabling New Vaccine Concepts and Delivery Through Particle Engineering. BioProcess Int. 11(9) 2013: S32–S40.

Della Porta G, Reverchon E. Engineering Powder Properties By Supercritical Fluid for Optimum Drug Delivery. BioProcess Int. 3(2) 2005: 48–54 and 3(3) 2005: 54–60.

Patil NV. Smart Polymers Are in the Biotech Future. BioProcess Int. 4(8) 2006: 42–46.

Brown LR. Formulation and Delivery: The 21st Century Brings New Challenges and Opportunities. BioProcess Int. 5(9) 2007: S43–S46.

Kim JJ. Electroporation-Enhanced Delivery of DNA Vaccines. BioProcess Int. 9(8) 2011: S10–S14.

Mire-Sluis A, et al. Drug Products for Biological Medicines: Novel Delivery Devices, Challenging Formulations, and Combination Products. BioProcess Int. 11(4) 2013 and 11(6) 2013.

Listen to the full presentation at www.bioprocessintl.com/BIO2016