Human vaccines

Although the principle of active vaccination is identical for every vaccine, the different nature of pathogenic germs requires specific technologies. The addition of vaccine adjuvants to enhance the body’s immune response has proven to be extremely powerful for some of the currently available vaccines to achieve strong protection. For more than 80 years, aluminium-based adjuvants have been the only licensed adjuvants for human vaccines. At Croda, we are committed to provide the vaccine industry with products meeting the highest quality standards. Alhydrogel® and Adju-Phos® are widely recognised industry-leading adjuvants produced in the only aseptic manufacturing site for adjuvants globally. 

The high potential of saponin-based adjuvants had been recognised earlier going back to vaccination studies carried out by Gaston Ramon, a French veterinarian, in 1925. Dr. Kristian Dalsgaard successfully purified and characterised a mixture of saponins from the bark of Quillaja saponaria Molina known as Quil-A® in 1974. Quil-A has since been used as a highly performing adjuvant in numerous veterinary vaccines. 

Finally, the isolation of a defined fraction of the saponin mixture enabled usage of saponins in human vaccines. In 1991, Dr. Charlotte Kensil et al. isolated and named QS-21 as a component of the triterpenoid quillaja saponins comprising different isomeric forms. QS-21 demonstrated an optimal balance of enhanced immunostimulatory properties and tolerable reactogenicity and has already been used in one commercialised vaccine. QS-21 is part of our offer and available for investigational use. 

New challenges for future development have revealed the need for new and high-performing adjuvants. Consequently, there is high research activity in the field of vaccinology and several promising adjuvant systems are entering the field. Recent research has also shown the potential of therapeutic vaccines aiming to treat and cure patients who suffer already from a disease. 

Both the preventive and therapeutic approach will require efficient adjuvants. We are passionately developing new adjuvant technologies and are strongly committed to contribute to the successful development of the vaccines of tomorrow. We are working to develop next generation saponin based adjuvant systems suitable for both veterinary and human application.  

Learn more about our portfolio of industry-leading and widely recognised adjuvants and contact us to discuss our latest pipeline developments. 

Research in vaccinology extends to new pathogen and population related challenges, such as, antigenic drifts or multiple serotypes and vaccines for elderly with immune senescence or infants with immature immune systems. Administration routes other than injections are also an area of research. 

These challenges may require new vaccine technologies including new types of antigens and delivery systems. Intensive fundamental research has paved the way for the development of mRNA-based vaccines. For these research activities, high-purity research products are essential. 

Explore the extensive list of lipids for research from Avanti Polar Lipids, a leader for high-purity polar lipids that are increasingly used as delivery systems for complex therapeutic drugs and in next-generation mRNA vaccines.

Apart from antigen and adjuvant, vaccine formulations contain further components. Depending on the technology, high-purity solubilisers or surfactants may be needed to ensure stability and shelf-life of the vaccine. By lowering the surface tension, they assist particles in remaining suspended in liquid, preventing them from settling and clumping. Frequently used excipients are polysorbate 20 and 80.

At Croda, we have developed a range of highly purified pharmaceutical excipients in which impurities commonly found in standard compendial grade excipients have been removed. 

Discover our Super Refined™ excipients comprising a wide range of polysorbates, polyethylene glycols and oils. 

Human blood plasma still essentially remains the only approach to obtain several protein products often used as the only available option in the prevention, management, and treatment of life-threatening conditions. 

One such protein is Factor VIII, also known as anti-hemophilic factor (AHF). Factor VIII is an essential blood-clotting protein and is used to treat deficient patients. During the purification process aluminium hydroxide is used to adsorb the protein which undergoes further purification steps. A high protein adsorption capacity of aluminium hydroxide is beneficial for process optimisation. 

Croda’s offer includes Alhydrogel® 85 with an increased adsorption capacity. It is a distinctly different product compared to Alhydrogel and is suitable for both blood plasma fractionation and vaccine development. 

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