Wednesday, March 25th, 2009
No, it’s not the humble grocery bag, but rather a new paradigm in drug processing: sophisticated multiple-layer sterile devices known as “bio-process containers” (BPCs) that serve as the centerpiece of techniques used to manufacture bio-therapeutic drugs — drugs that use a person’s natural immune system to treat an illness.
These bio-process containers are made of plastics. They are converted from medical grade resins and polymer films, and created in multi-layer sizes that range from a deck of cards to a pick-up truck.
Their biggest asset? These disposable, modular plastic bio-systems dramatically increase flexibility to make process changes quickly and enable manufacturing systems that can be inexpensively and efficiently deployed, not just in traditional drug manufacturing settings, but in critical emergency field applications that require rapid production.
Example of their use? Flu vaccines. There is rapidly mounting evidence that not only are we due for a major, virulent flu pandemic, but that plastic will be needed to create the cure – quickly.
Whenever you receive a flu shot, the caregiver always asks if you have an egg allergy because every dose of flu vaccine is gestated in nature’s own bio-container – the egg. One egg for every one dose of vaccine. This makes for slow production times and is also the reason a flu vaccine costs $20-$25 — they’re capital and labor intensive to produce.
But what if there was an urgent need to produce one million doses of a specific vaccine due to an outbreak of a killer flu? Or, what if, as happened in 1918, a flu spread so rapidly that it led to the death of 50 million people worldwide? If you were a chicken, you would be gainfully employed. If you were a human, you’d be looking for the nearest clinic — but the lines of people waiting would resemble the worst day at the DMV. Forget one million; even producing hundreds of thousands of life-saving vaccines using the traditional egg method would take way too much time in the face of a fast-moving global influenza epidemic.
The processes currently in development are high-yielding relative to egg-based approaches. Disposable manufacturing systems can be used and the high up-front cost of facilities is eliminated. The need to clean/sterilize equipment between batches is eliminated as product-contact surfaces are disposable. The complex, automated facilities required to perform these tasks are avoided, as is the lengthy commissioning and validation of those processes. The result is a facility that can be built for about one fourth of the cost of a traditional one and in half the time.
While we all hope that we never have to face a tragedy similar to 1918, the unfortunate odds are that we will, to some extent, in the next decade. But take heart — there is technology in development that will mitigate illness and mortality, and it will be enabled by a (not-so humble) plastic bag.
(Want to learn more? SPI is advancing the adoption of Single Use process systems through its Bio-Process Systems Alliance.)