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When it comes to drug development, immunogenicity is one concept that has risen up the agenda for pharmaceutical companies in the past few years. Much investment has been placed into improving the potential for a drug to trigger a person's immune system, particularly due to both new guidelines on the issue and the potential risks that could arise from the release of a drug that causes a negative reaction.

Technology has understandably played a major role in the creation of new drug development policies, strategies and techniques that can be used to test the effectiveness of new products. Some breakthroughs may involve the equipment used during the assessment process or substances that can be used to boost certain products.

One item that can be placed in the latter category is NasVax's adjuvant technology VaxiSome. Created to both stimulate the immune system and responses to vaccines, the product has recently been the subject of a joint research and option for licence agreement between its manufacturer and Novartis.

VaxiSome is produced from a synthetic polycationic sphingolipid derived from D-erythro ceramide, to which spermine is then attached to create ceramide carbamoyl spermine. The solution is then missed with cholesterol, which is when it self-assembles into liposomes known as VaxiSome. Studies have suggested that the adjuvant could prove potent in stimulating immune responses via the Th1 and Th2 pathways.

Pre-Clinical studies have shown that the VaxiSome-Influenza is more immunogenic than two commercial adjuvanted influenza vaccines, while adjuvanted hepatitis B, anthrax, and pandemic flu vaccine antigens also experienced higher levels of potency. Novartis has up to 14 months to exercise its non-exclusive licence covering the adjuvant technology from the agreement's effective date, although it could be extended under certain conditions.

Erez Chimovits, chief executive officer of NasVax, said the agreement with Novartis was "another major step" in its strategy to launch "innovative technologies to the market through collaborations with world-leading vaccine manufacturers". VaxiSome seemingly looks set for a bright future, but the technology is not the only type to be improving the efforts of those involved in drug development to consider immunogenicity . Pharmaceutical technology provider NanoSight recently confirmed that its LM20 equipment is now being used by a research team working for the Leiden/Amsterdam Center for Drug Research (LACDR), which is based at the Gorlaeus laboratories in the Netherlands.

The system is designed for nanoparticle analysis and is compatible with 0.3ml samples. Scientists can then use NanoSight's Nanoparticle Tracking Analysis software suite to track and size results on an individual basis. According to Azanano.com, before using the technology, the LACDR team used a range of techniques, such as dynamic light scattering, which all had deficiencies in terms of speed of use and sample preparation.

According to the leader of the team Professor Wim Jiskoot the LM20 system would be key as the researchers work to consider vaccine delivery and protein formulation with respect to immunogenicity. He told the website: "It is very important to know the size of the delivery systems as the size can influence the uptake by the cells of the immune system, the diffusion through the skin, the release of vaccine components and thus the immune response."

The group of scientists are presently concerned with understanding what causes unwanted immunogenicity of therapeutic proteins, as well as the development of mouse models able to predict immunogenicity in human proteins.

Professor Jiskoot said: "For the protein group, a good size characterisation of protein aggregates is essential to better understand which size class is responsible for triggering unwanted immunogenicity of therapeutic proteins which is believed to be related to the presence of aggregates in the protein formulations."

Technological advances like those mentioned above are helping drug developers and researchers to improve their work while also increasing the likelihood of new products and vaccines becoming available sooner. New breakthroughs in immunogenicity are bound to occur in the near future which will then push the sector forward even further.

All of this is vital in the Pharmaceuticals sector, where the release of new guidelines and regulations mean companies need to be open to both changes in the strategies they employ during drug development. A technological approach looks set to be vital to firms for the foreseeable future.

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asay development

The Technological Approach to Immunogenicity

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