Published on Aug 04, 2024
The vaccine must comply with the release specifications for production and storage time, and the stability of the product must be confirmed by long-term stability studies.
Even if vaccines are licensed, several batches are tested for stability each year to ensure that any changes made do not have a harmful effect. Stabilisation can be achieved by pH with appropriate buffer preparations or by lyophilization (freeze drying) to dewater naturally unstable products such as some live viral vaccines.
Lyophilization creates a dry form that is less likely to spoil and can be rehydrated shortly before use. In extreme cases, formulation requirements alone can increase costs severalfold and, in the case of lyophilization, significantly reduce capacity while adding significant capital and operating costs.
There are many different production platforms in use today for vaccine production.
The ability to recruit, train and develop Production and Quality personnel to maintain Process and Quality Systems is a challenge even for highly experienced manufacturers. Technical competence is crucial as detailed knowledge of the latest technologies and global regulatory authority requirements is mandatory. Globally, the shortage of personnel with the necessary skills and expertise needed by the vaccine industry is one of the most talked about topics.
In a way, vaccine production means deep scientific knowledge and a constant curiosity to understand and detect the subtle signals that a biological process can send that cannot be detected in the released data.
Experienced workers must use caution when responding to changes in processes or facilities or equipment failure. Sustaining vaccine production is possible by developing a strong basis of scientific, technical, product-specific production and quality control system knowledge.
Countries with large populations and solid technical and scientific education systems, such as India, Brazil and China, which we need to examine carefully, have managed to train skilled workers suitable for the sustainability of highly elaborate vaccine manufacturing. For an average vaccine facility in low- and middle-income countries, if it does not have a trained skilled workforce, typical staffing will include imported workers. Most imported personnel will demand higher total compensation and benefits than domestic employees, increasing the overall labor cost and reducing local employment opportunities.
Vaccines are generally made using raw materials produced by biological production processes (e.g. yeast extract, natural or recombinant enzymes). These materials introduce inherent variability into manufacturing or analytical processes. Because they require specialised knowledge and skills, these raw materials may be limited in supply and subject to shortages or process changes as suppliers change their methods to increase productivity. Additionally, when products are derived from materials of animal origin, they run the risk of adventitious substances that can potentially contaminate the manufacturing process.
Due to the normal dynamics of supply and demand, materials supplied on short notice are often expensive.
If a Vaccine Manufacturer reduces supply risk by contracting with multiple suppliers for critical supplies, the quantities ordered from each supplier will decrease, resulting in higher prices. However, when produced locally, consumables could be an area of cost savings for vaccine manufacturers in low-income countries, with prices estimated to be as much as 15-25% lower than rates in high-income countries.
For more, join Mustafa Edik on our course on GMP Princiles in Vaccine Manufacturing.
Published on Aug 04, 2024 by Mustafa Edik