Johnson and Johnson (JNJ)

[Trend-Setter]

MACIVIVA = Game Changer

"Vaccines are often produced as liquid biological products containing > 80% of water, which explains in part their instability during the storage in laboratories, hospitals, or manufacturing facilities. Liquid vaccines are inherently prone to physical and/or chemical modification, and degradation might also affect the immunological properties of the vaccine immunogens, with unwanted immune responses or insufficient immune protection. There is growing evidence that solid vaccine forms (e.g. powder) may offer several advantages over the liquid formulations, such as slowing down modifications and degradation.
The vaccine industry has developed freeze-drying lyophilization with low residual moisture content for improving stability and extending vaccine shelf-life. Such vaccines are stored as stable lyophilized dry products in a continuously frozen state at < -18°C, while others can be stored in refrigerators (+2-8°C). Therefore, maintenance of the cold chain is fundamental for preserving the bioactivity of most liquid and lyophilized vaccines currently on the market as well as those under development. However, many regions of developing countries also lack electricity and cooling capability for keeping vaccines below +8oC. The development of cold-chain independent vaccines in solid powder forms may greatly simplify the logistics and represent one of the long-term global solutions for addressing important issues faced by the vaccine field."

"Furthermore, lyophilized vaccines must be reconstituted with a diluent prior to administration, which implies also that lyophilized vaccines must be packed and shipped together with vials/syringes containing the diluents for reconstitution. As most of the standard liquid vaccines, reconstituted lyophilized vaccines are generally administered intramuscularly, subcutaneously or intradermally with syringes. All the above suggests that liquid and freeze-dried vaccines, despite their good immunogenicity and stability, could be further improved by: i) Developing vaccines that are more thermostable, which means able to support high and low temperature excursions outside the recommended cold chain conditions or storage outside the cold chain; ii) Circumvent the powder reconstitution step prior administration; iii) Needle-free vaccination by one of the mucosal routes (sublingual, nasal or oral) with the solid vaccine powder forms."

"MACIVIVA Consortium has for main objective to develop robust “universal-like” manufacturing processes by heat spray drying or freeze-drying for obtaining new thermostable virosome dry powders for novel vaccine formulations for sublingual, oral and intranasal delivery, each representing a different manufacturing Pilot Line allowing GMP scale-up. If the project is successful, these thermostable virosomal vaccines could be stored outside the cold chain without affecting the vaccine properties, simplifying the logistics and addressing one of the major problems in the vaccine field. In the future, this may also allow the manufacturing of other human safe virosome-based vaccine formulations, as well as other vaccines. These innovative needle-free vaccines could be self-administered directly to the subject through the following non-invasive routes: Intranasal, oral and sublingual, without the need of reconstitution, favoring a broad acceptance in the target population."

"From May 2015 to October 2016 (M1-M18), all six MACIVIVA partners have closely collaborated together to achieve the project milestones and objectives set for this period. During the downstream processing from liquid to solid dosage forms, various analyses on virosomes were performed to make sure that they retain their original physical and biological properties after formulation as sublingual tablet, nasal spray and oral capsule. Mymetics SA had produced 12 different virosome fomulations during the first 18 months of the project, which were distributed among Upperton, Catalent, Chimera and Mymetics SA/BV. Catalent and Upperon have then evaluated various buffers and excipients for identifying the most suitable one for preserving the initial virosome structure, antigens and pH, respective to their own manufacturing process. Several manufacturing process parameters were investigated and optimized."

Full Coverage Report: http://cordis.europa.eu/result/rcn/194900_en.html


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