At the start of 2020, the world experienced being put on stand-by after COVID-19 spread from China to the rest of the world. The pharmaceutical industry is therefore working hard these days to ensure that a vaccine can be developed and mass-produced so that we can get back to normal everyday life.
However, an overriding challenge when developing and producing a vaccine in the middle of a pandemic is that production must be scaled up to the billion scale – from the raw materials in the vaccine to the final end product – and this is where the single-use technology becomes interesting.
Scale up, scale up, scale up!
When the pandemic rages outside the laboratory window, the timeline from developing to producing and distributing the approved vaccine is significantly compressed. Companies may therefore be forced to produce the vaccine before it is approved, in order to be at the forefront if it is approved. It is therefore crucial that the companies can scale up their production significantly in a relatively short time.
As soon as the final vaccine is found, the key to success is that the individual manufacturer has sufficient raw materials, production facilities and labor to meet demand. In addition, it is crucial whether you are able to transfer the technology to other production facilities which may be spread out geographically. A flexible, modular design will mean that a vaccine manufacturer can quickly adapt to the massive demand for billions of doses of vaccines. The single-use technology is therefore an obvious technology to use when a massive upscaling of the production capacity is to take place.
Transfer of technology
Technology transfer involves many different departments and experts in a pharmaceutical organization. It is a task where you can encounter unforeseen challenges even though a process may seem simple. A combination of a gap and risk analysis must highlight and identify important areas in the process that are crucial for a successful technology transfer. There are many departments involved in the process of technology transfer such as product development, production, quality assurance and quality control, qualification and validation and regulatory.
It is important that all stages of the process are evaluated from start to end product. Right from visual inspection and packing to the aseptic part to, for example, mixing, sterile filtering and filling.
As a starting point, all technology transfer must be based on the FDA’s approach:
- Process design
- Process qualification
- Continuous process verification
The aim is to achieve a robust, reproducible production process with a uniform quality on the site that receives the process.
We have more than 20 years of experience with qualification, validation and quality assurance in the pharmaceutical industry.
Single-use can be a solution for quickly scaling up the production of the Covid 19 vaccine – and that is why we at AL Engineering are ready to help with whatever challenges it may present. We can e.g. help qualify and validate (read more here) as well as support with quality assurance within pharma (read more here).
