Taking a page from semiconductors
By Chris Procyshyn
CEO, Vanrx Pharmasystems
At an industry conference a couple of years ago, following a panel discussion on aseptic technologies, a question was left to linger in the air by an attendee: “Why do we not look at other industries for ideas?” There are problems being solved for slightly and sometimes radically different issues which we can and should readily adopt.
When the microphones were turned off and people were packing up, a colleague of mine on the panel stated “It’s because pharma is too inbred. Nobody leaves for other industries, and nobody comes in from other industries”. Pretty blunt, but not far off.
Despite radical changes in the products themselves, the accepted levels of quality and the global nature of today’s pharma market, not much has changed in the last thirty years in injectables manufacturing. Many, if not most manufacturers are slow to non-existent in their use of new technologies, despite high costs, low uptime and other difficulties in using the “tried and true” manufacturing methods. Insistence on highly custom production lines, custom containers, and custom packaging all together lead to a very expensive way to make medicine.
The new reality for many is “smaller, more complex and much more expensive”. Companies are making products for smaller groups of patients, and these products are much more expensive and sensitive. It begs the question “What industry is really good at making small, complex and expensive things?”.
Then ask yourself: Why is a computer small enough and cheap enough to be purchased and given to a seven year old?
Smaller, faster, more complex
Semiconductor and microelectronics manufacturing is a fast-paced, highly competitive market where customers are generally quick to adopt the latest technology. Because of this, their manufacturers must be as well. No room for complacency or you’re done. Period.
So, what are they doing that we should be doing?
One key concept is cellular manufacturing. Not as biopharma would call cellular manufacturing, where we are actually manufacturing live cells, but manufacturing in which the functions are broken down into their smallest, integrated block: the Workcell. Take everything you need to get done, shrink it down to the highest intensity possible, and then clone it.
This strategy optimizes flexibility while reducing risk, by scaling out and not up. The same process exactly, just more of it. And by doing so, if there’s a problem with one workcell, all the others are still in operation. Need to add more? No worries, it will be the same as the last.
Semiconductor wafer fabs, along with many other areas of advanced manufacturing have devoted their processes to workcell manufacturing. Through the use of specially designed clean industrial robots, and basic levels of standardization between manufacturers, they have radically improved the yields and reliability of modern microchips, to the point now where they are producing integrated circuits with structures less than 14nm in width.
To put that in perspective, poliovirus is generally 27nm in diameter. A commonly held belief in pharma goes something like “Yeah, but semicon doesn’t have the concerns about microbial contamination”. They are producing structures with a high level of quality where they are able to prevent contamination of particles down to and below the size of some of the smallest viruses. I’m pretty sure they can keep out the staphylococcus while they are at it.
They are using specially designed industrial robots that are intrinsically clean, not simply robots from other dirty applications with a better coat of paint or a shinier finish. And with an understanding that the process must be reduced to most simple and reliable form.
This is what is necessary to establish workcell manufacturing. It can be done, and is being done… in pharma, now.
Living in Vancouver, in many ways we are on the edge of a number of industries, cultures and experiences. You cannot help running into somebody from somewhere else who has done things differently. And that attitude drives us.
We at Vanrx have undertaken the effort to redesign the aseptic injectable dosage filling process from scratch. Blank sheet of paper. Along the way, we have realized analogies that make sense to us.
By delivering a complete solution in an integrated workcell, the requirements for cleanroom space and container handling are greatly reduced. Removing gloves and humans from the process results in greater sterility assurance and increased process reliability.
Inspired by the success of the semiconductor industry, we developed an efficient solution that simplifies operations and reduces costs, while providing the highest sterility assurance. Instead of processing each vial individually, we developed a method to work with vials, cartridges, and syringes directly in an ordered nest, eliminating direct handling and breakage. Closing and capping are also done with nested components in the same filling workcell.
We have learned from the semiconductor industry and are working with leading pharmaceutical manufacturers and container suppliers to revolutionize the industry. Instead of trying to solve today’s problems with yesterday’s outdated technology, Vanrx is leveraging other industries’ technological advancements to drive pharma into the future.