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Numerous advantages to inhalation vaccines Vaccines delivered via inhalation enable targeting of the respiratory tract mucosa and generation of both humoral and cell-mediated immunity, according to Pierre A. Morgon, executive vice president. [...]inhaled vaccines delivered as liquids using nebulizers can potentially be administered with lower requirement for extensive healthcare infrastructure or as many trained healthcare personnel within an immunization centre (2). Researchers at McMaster University, for instance, have shown inhalation of a tuberculosis vaccine to be more effective than delivery via nasal sprays, because the vaccine penetrates much deeper into the airway (8). Because inhaled vaccines provide local immunity to the respiratory tract, they are seen to be ideal solutions for interrupting the spread of viruses with high transmission rates and the potential to lead to global pandemics (9). Beyond these two approaches, there are inhalation vaccines under development based on attenuated influenza virus, parainfluenza virus (PIV) 5, lentiviruses, Newcastle disease virus (NDV), and vesicular stomatitis virus (VSV);bacterium vectors, nucleic acids (messenger RNA, DNA), and protein subunits (3).
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Advances in technology are accelerating the development and manufacture of this established class of vaccines. Because they contain only a portion of the pathogen, subunit vaccines typically have fewer side effects and can be given to a wider group of people, including those with compromised immune systems and chronic health conditions. In addition to having transparent and scenario-based forecasting in place to anticipate risk-based future global demand scenarios, managing cold-chain requirements regarding storage and transportation remains a key capability, especially considering the variety of temperature classes (i.e., cool-chain to deep-frozen, all the way down to liquid nitrogen temperatures)," comments Christian Rochel, head of supply chain for biologies at Lonza's Visp, Switzerland facility. Magers points to progress in genomics for the identification of vaccine candidates and incorporation of three-dimensional (3D) structure, domain organization, and dynamics of surface proteins analysis into vaccine design as aiding development efforts. Manufacturing advances of note for Magers include expanding use of different expression systems including mammalian, insect, microbial, and fungal cell lines;incorporation of single-use technologies and equipment and closed systems into manufacturing processes;exploration of continuous manufacturing and quality-by-design approaches;and the introduction of novel analytical methods (e.g., mass spectrometry, particle analysis methods, and capillary electrophoresis) in conjunction with an emphasis on replacing in-vivo potency assays. Since the first subunit vaccine was approved for hepatitis B, Novavax has advanced the technology for this class of vaccines through its use of a nanoparticle core to present the protein subunits to the immune system in a way that results in robust, durable responses that offer protection in the face of genetic drift, according to the company's spokesperson.
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With additional safety protocols required in the manufacturing environment, gatherings of large people generally prohibited, and onsite inspections limited due to restricted travel, ensuring quality throughout the supply chain from raw material to API is more challenging. Employee safety is always a priority for Thermo Fisher Scientific, and since the start of the COVID-19 pandemic the company has focused on protecting their health and safety while continuing to serve the needs of its customers, according to Vice President of Drug Substance Quality, Ben Gerlach. [...]of the support, flexibility, and discipline of our colleagues and supply chain partners, as well as the IT infrastructure available, all Thermo Fisher API manufacturing sites have remained operational since the start of the pandemic with continued GMP compliance," Gerlach remarks. Expanding our footprint and ensuring supply chain redundancy has enabled us to minimize the risk of supply chain interruptions and work with partners efficiently," he explains. Because of the circumstances connected with COVID-19, Ross also stresses that it is extremely important to frequently engage with supply chain partners to ensure that Cambrex understands the impact of the pandemic on their businesses and any potential downstream effects on Cambrex's unit operations that might ensue.
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Stability, dosage, and other challenges Developing an FDC formulation that offers these benefits and challenges can be difficult, however. Because many active ingredients are incompatible-meaning they are less stable in the presence of each other-selecting excipients and processes that reduce the degradation rate of the active ingredients and afford the optimal composition and process parameters increases in difficulty as the number of active ingredients increases, Gren notes. [...]the main challenge to fixed-dose combination development usually involves product formulation and manufacturing strategy to address stability, dose differential, and analytical method development issues, according to Kane. [...]Kane observes that the packaging of a fixed-dose combination product may need to be re-considered based on the criticality of the multiple actives and their stability profiles in combination.