Stainless Steel's Silver Slipper
By Rob Wright, Chief Editor, Life Science Leader
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By Rob Wright
In July I had the opportunity to attend the Bio-Process Systems Alliance (BPSA) International Single-Use Summit in Washington, D.C. Formed in 2005, BPSA is an industry-led corporate-member trade association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. In my opinion, BPSA has been successful at encouraging single-use adoption.
However, I would argue that until single-use vendors can come to an agreement on components where standardization can be achieved, it will remain a distant second to stainless steel as the preferred means of biopharmaceutical and vaccine production. This point was made clear by Merck’s Jim Robinson, who gave a presentation citing examples of standardization which exist in stainless steel systems, such as fittings and filters, which allow vendor differentiation while also allowing end-users flexibility and options.
Lack Of Standardization = Lack Of Adoption
Robinson, VP of vaccines product & tech operations, is a self-described advocate for single-use technologies. During his presentation at the summit, he expressed frustration that single-use hasn’t advanced more. He pointed out a number of benefits to adopting single-use manufacturing, such as reduced infrastructure, reduced facility set up time, easier tech transfer, and reduced risk of cross contamination. So why hasn’t more of industry jumped on the single-use bandwagon? According to Robinson, in the vaccine space, reliability of supply is the most important differentiator. “If you want to lose your marketplace, have a supply problem,” he stated. “If you want to gain market share, have reliable supply so that when your competitor loses their supply, you are able to step in and reestablish yourself with the customer.” One of the biggest selling vaccines in the world is a $4 billion annual product. If the company was relying on a single-use component for manufacture and the vendor discontinued, changed, or had a production issue with that component, it is a substantial amount of business to put at risk. The level of robustness of single-use manufacturing processes has yet to reach that of traditional stainless steel equipment. Combined with the lack of standardization in disposables, end users may feel that they are at vendor’s mercy. According to Robinson, the pharmaceutical industry is a fairly conservative group of people who aren’t willing to be held hostage to someone else’s quality standards and systems. Robinson believes that for single-use to be increasingly utilized, parts need to meet a mutually agreed upon expectation, be readily available from multiple suppliers, and on a standard platform which allows for connectivity. In an effort to help, Merck has created a single-use network which is working on developing standards. In the meantime, it seems that, though more costly, stainless steel provides less risk, superior connectivity, and the reliability companies manufacturing vaccines seek.
Who Should Drive Single-Use Standardization
In discussions with multiple vendors, the consensus seems to be that end users (pharmaceutical/biotech companies) need to drive the standardization process. Jerry Martin, chairman of the board for BPSA, sees patent protection expiration as a necessary element to the eventual standardization of the industry.
Eric Langer, managing partner, BioPlan Associates, noted that lack of standardization in the single-use industry is tantamount to leaving 60% of potential available business on the table. Thus, the debate remains, who should drive the single-use standardization process — the product developer (vendors), the customer (end users), or some combination of the two? Steve Jobs, former CEO of Apple, was of the opinion that customers didn’t know what they wanted until you showed it to them. Perhaps by BPSA serving as a forum to bring end users and vendors together for an open dialogue on industry issues, the process of achieving standardization in single-use will accelerate. In the meantime, stainless steel is reaping the financial rewards gained from interoperability and standardization provided for its risk-averse customers.