The pharma industry continues to expand its R&D pipeline, even the Covid-19 pandemic has been unable to halt the development of new drug approvals for patient use. The pandemic, like many before it, had the capacity to change the world, causing economic downturns, panic buying and complete border closures but in the midst of chaos, there is also opportunity, for collaboration and sharing of information to expedite drug development, the industry is poised to both think, and act differently.
While continuing to invest in expanding our portfolio and manufacturing footprint globally, quality is at the forefront of our plans. We are ambitious and influential in this area; being the first excipient supplier to receive EXCiPACT certifications across multiple sites and pioneering new monograph approvals via our representation on the global monograph bodies. We continue to invest in our pharma business, tripling the number of innovation centres, ensuring global presence close to our R&D community, doubling the capacity for our speciality excipients and injecting millions into our core manufacturing sites for lipids and adjuvants.
Mergers and acquisitions are common in the industry with 2020 being particularly prolific. We are committed to strengthening our pharmaceutical offering through continued acquisitions. In 2018, we invested in Brenntag Biosector, whose experience in aluminium and saponin-based adjuvants dates back to 1939. Their expertise was a great extension to our range and proved crucial in combatting the pandemic. Just before the pandemic hit in 2019, we acquired Avanti Polar Lipids, a further step towards our commitment to the pharma industry and new exciting business models. Avanti has a long history in lipid-based drug delivery dating back to 1967, their lipid technology has been heavily influential in delivering the mRNA technology during the pandemic and will continue after its demise.
The pharma industry was once dominated by small molecules, but the last few decades have seen an increase in biotechnology, a highly specialised set of molecules designed to complete very special tasks, evolving the industry to where we are today. This revolution has led to a change in pipeline drugs by delivery route, with more and more administrated through injection. Our products have been specially innovated for use in biopharma. Our super refined excipients stabilise drug proteins; our prescription drugs team utilises products used in bioprocessing; and our vaccine adjuvant technology is produced in an aseptic environment using Super Refined™ excipients.
Prescription drugs
Excipients are vitally important to optimal drug delivery.
Prescription drugs are generally prescribed by a doctor and intended for use in the diagnosis, cure mitigation, treatment or prevention of various diseases. Usually purchased at a pharmacy, all drugs are made up of two core components – the active pharmaceutical ingredient or API and one or more excipients. The API is the central ingredient in the drug or the part of the drug that produces the intended effect. Pharmaceutical excipients are substances other than the API that have been appropriately evaluated for safety and are intentionally included in the drug delivery system, whether that is a tablet, a cream, a softgel or an injectable. Traditionally, excipients were often structurally simple, of natural origin and biologically inert. However, during the last few decades, many more novel and increasingly complex functional excipients have been developed as novel drug formulation delivery systems have evolved and emerged. These excipients are generally stable and reproducible, are pharmacologically inert and deliver the desired functionality.
Human vaccines
One of the greatest medical advances in modern times.Vaccination is considered one of the greatest achievements in modern medicine. It's history dates back to 1798 when the first smallpox vaccine was developed. Since then, vaccines for the prevention of more than 25 life-threatening and disabling diseases have been licensed. 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.
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Pharmaceutical excipients for prescription drugs
We offer a vast portfolio of excipient solutions for prescription drugs, from specialised lipids to high purity speciality chemistries to key functional ingredients which solve challenges faced by pharmaceutical manufacturers and formulators. Within a particular formulation, excipients can have different roles. Some of the major ones can be:
- Aid in the processing of the drug delivery system during its manufacturing
- Protect, support, or enhance stability, bioavailability or patient acceptability/compliance
- Assist in the effectiveness and/or delivery of the drug in use
- Assist in maintaining the integrity of the drug product during storage.
The importance of quality
We understand the importance of excipient quality in pharmaceutical development. We know that producing stable and effective drug formulations is one of the main challenges faced by pharmaceutical formulators in general. This is why all of our excipients are designed and manufactured for pharmaceutical use, using Good Manufacturing Practice (GMP) standards, from start to finish, across all our platforms and manufacturing sites. We were one of the first excipient suppliers to receive EXCIPACT (or equivalent) certifications across all our global sites and we continue to pioneer new monograph approvals via our representation on global monograph industry forums. We believe that having the highest quality and purest grades of excipients helps our customers formulate seamlessly and drive products to market quickly and efficiently.
Offering the most highly purified excipients available, our Super Refined™ range of excipients are manufactured through proprietary processes that physically remove impurities without affecting the fundamental structure in any way. The removal of these impurities adds value to the formulated drug product by reducing negative API/excipient interactions and minimising the potential for oxidation, thereby maintaining the stability of the drug and the final formulation, increasing product shelf life. In addition, the removal of impurities can minimise cellular irritation, ideal for various drug administration routes as well as improve delivery of the API and minimise taste impact, highly valuable for oral drug formulators.
Impulsionada por pesquisa e inovação
Portanto, se são excipientes de entrega de fármaco auto-emulsionantes para solubilizar um IFA difícil para uma aplicação de cápsula em gel específica, ou intensificadores de permeação e emulsificantes para melhorar a entrega de um creme ou loção para a pele, ou polissorbatos de alta pureza para estabilizar e solubilizar produtos biológicos complexos e formulações parenterais, nós queremos fazer parceria com você para fornecer soluções, soluções que impulsionam o crescimento e a inovação que melhoram a vida das pessoas.
A vaccine offering founded on research and development
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.
Avanços no desenvolvimento de vacinas
A pesquisa em vacinologia se estende a novos desafios relacionados a patógenos e populações, como, por exemplo, variações antigênicas ou múltiplos sorotipos e vacinas para idosos ou bebês com senescência imunológica ou sistemas imunológicos imaturos. Outras vias de administração que não as injeções também são uma área de pesquisa.
Esses desafios podem exigir novas tecnologias de vacinas, incluindo novos tipos de antígenos e sistemas de distribuição. A pesquisa fundamental intensiva preparou o caminho para o desenvolvimento de vacinas baseadas em mRNA. Para essas atividades de pesquisa, produtos de pesquisa de alta pureza são essenciais.
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.
Inovação além de adjuvantes
Na Croda, desenvolvemos uma variedade de excipientes farmacêuticos altamente purificados nos quais as impurezas comumente encontradas em excipientes de grau compendial padrão foram removidas.
Descubra nossos excipientes Super Refined™ contando com uma ampla gama de polissorbatos, polietilenoglicóis e óleos.
Proteína terapêutica para salvar vidas
Uma dessas proteínas é o fator VIII, também conhecido como fator anti-hemofílico (AHF). O fator VIII é uma proteína essencial de coagulação do sangue e é usado para tratar pacientes deficientes. Durante o processo de purificação, o hidróxido de alumínio é usado para adsorver a proteína que passa por outras etapas de purificação. Uma alta capacidade de adsorção de proteínas do hidróxido de alumínio é benéfica para a otimização do processo.
Oferecemos Alhydrogel® 85 com uma capacidade de adsorção aumentada. É um produto distintamente diferente em comparação com o Alhydrogel e é adequado tanto para o fracionamento do plasma sanguíneo quanto para o desenvolvimento de vacinas.