Vaccine Manufacturing

Reliability of adequate vaccine supply is critical for human vaccines. The manufacturing process needs to be scalable at industrial level, robust, and consistent. It is required to encompass an evaluation of all components, raw materials, intermediate and final products, quality control and analytics, and equipment design and facilities. The stability of vaccines remains a real challenge, mostly caused by antigens and/or formulations affected by cold-chain limitations during production, storage, transportation, and delivery at immunization clinics. In addition, manufacturing issues may disrupt access to adequate supplies of important vaccines, such as the influenza vaccine. Whereas application of innovative technologies to the discovery of antigens and assessment, development, production, and registration of vaccines are being used to overcome the challenges, manufacturing of influenza vaccines still remains an annual challenging race against time to deliver in a timely way the required doses with the right composition (in October for the Northern hemisphere and in March for the Southern hemisphere). New technologies, such as vaccine-like particles and novel adjuvants, may represent alternative, promising approaches; nevertheless, caution on increased costs of producing new vaccines and lack of clarity in guidelines and regulations remain challenges for vaccine manufacturers and regulators.