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Drug Formulation

immune response. Currently most ad- shortages in vaccine production. Avan- Afr. J. Pharm. Pharmacol, 7(48),
juvants only activate the humoral im- ti, now part of Croda Pharma, supplies pp.3034-3059.
mune response; whereas ISCOMs are pure, plant-based parenteral cholesterol 3. Zhang, X., Barraza, K.M. and Beau-
able to induce strong activation of both that meets USP-NF, Ph. Eur. (2397) champ, J.L.,2018. Cholesterol pro-
the cell mediated and humoral arms of and JP pharmaceutical specifications. vides non sacrificial protection of
the immune system, generating long- The parenteral grade plant-based cho- membrane lipids from chemical
lasting biologically active antibodies lesterol can be used as a high-purity al- damage at air-water interface. Pro-
and a strong cellular response . In ternative to traditional egg- and animal- ceedings of the National Academy
8,9
addition to the immunological ben- based cholesterol. Acting as a stability of Sciences, 115 (13), pp.3255-3260.
efits, ISCOMs technology can provide enhancer and assisting in the transfec- 4. Raffy, S. and Teissie, J., 1999. Con-
commercial benefits including great tion of nucleic acids, it is available for trol of lipid membrane stability by
flexibility in vaccine design due to both R&D work and parenteral applica- cholesterol content. Biophysical
the ability to mix the ISCOMs matrix tions. journal, 76(4), pp.2072-2080.
with the required antigen at the post- 5. Cheng, X. and Lee, R.J., 2016. The
manufacturing stage. One of the most A long-term lipid innovations part- role of helper lipids in lipid nanopar-
successful ISCOMs is the AS01b for- ner ticles (LNPs) designed for oligo-
mulation used in the Zoster vaccine Croda Pharma offers its innovative nucleotide delivery. Advanced drug
(Shingrix) which has been proven to Avanti lipids portfolio in both research delivery reviews, 99, pp.129-137.
be effective at preventing Shingles in and GMP grades. This expanded ca- 6. Bae, Y.U., Huh, J.W., Kim, B.K.,
adults. This system is formulated with pability follows Croda’s acquisition of Park, H.Y., Seu,Y.B. and Doh, K.O.,
a combination of monophosphoryl Avanti Polar Lipids, a leading partner 2016. Enhancement of liposome
lipid A (MPLA) and QS-21 adjuvants, for the development and formulation of mediated gene transfer by adding
as well as cholesterol and a phospho- lipid technologies to address key formu- cholesterol and cholesterol modulat-
lipid. AS01b is also being tested in lation challenges. Croda’s high-purity ing drugs. Biochimica et Biophysi-
clinical trials as a component of Mos- lipids and excipients can be utilised in ca Acta (BBA)-Biomembranes,
quirix (the first approved malaria vac- delivery systems for complex therapeu- 1858(12), pp.3017-3023
cine) and HIV vaccines. Cholesterol tic drugs and in next-generation mRNA 7. Morein, B. and Bengtsson, K.L.,
is an important component in many vaccines, supported by a vast portfolio 1999. Immunomodulation by is
ISCOMs, including AS01b, and is be- of phospholipids, cationic lipids, PEG coms, immune stimulating complex-
ing investigated in next-generation lipids, sterols, and more. es. Methods, 19(1), pp.94-102.
AS01b-like systems. 8. Lövgren Bengtsson, K., Morein, B.
References and Osterhaus, A.D., 2011. ISCOM
Plant-based cholesterol 1. Shrestha, H., Bala, R. and Arora, technology-based Matrix M™ adju-
Currently, most cholesterol used in S., 2014. Lipid-based drug delivery vant: success in future vaccine sre-
industry is sourced from animal materi- systems. Journal of pharmaceutics, lies on formulation. Expert review of
als and extracted from either lanolin or 2014. vaccines, 10(4), pp.401-403.
animal tissues. Plant-based cholesterol 2. Chime, S.A. and Onyishi, I.V., 2013. 9. Pearse, M.J. and Drane, D., 2005.
eliminates the impurities and potential Lipid-based drug delivery systems ISCOMATRIX® adjuvant for anti-
contamination associated with animal- (LDDS): Recent advances and ap- gen delivery. Advanced drug deliv-
based cholesterol and can address lipid plications of lipids in drug delivery. ery reviews, 57(3), pp.465-474.

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Chemical Weekly October / November 2023 39