Innovators In The Pharmaceutical Packaging Industry
By Louis Garguilo, Chief Editor, Outsourced Pharma
Leaving loose ends wouldn’t be appropriate when covering an industry devoted to the highest standards of pharmaceutical packaging. We promised to return to three questions posed at the end of our recent article with Dan Marasco, head of Packaging Materials & Device Sourcing, Bristol-Myers Squibb. To answer those more fully, we needed to talk to a service provider. Karen Flynn, president, Pharmaceutical Packaging Systems at West Pharmaceutical Services, shall we say, delivered the goods.
Here are the questions from the original article Boxes At BMS: Impact Of New Drugs On Packaging Sponsors And Providers:
- Are there enough educated and trained packaging science professionals in and entering the pharmaceutical industry, including on the side of service providers?
- Is there a vibrant service provider industry – including new entrants – for this era of new drugs and supply-chain challenges?
- Is there enough innovation, and how does it become a built-in component, of this segment of pharmaceutical outsourcing?
Flynn provided insight on these from West’s headquarters just outside Philadelphia.
Packaging Professionals
Unlike BMS’s Marasco, a trained packaging expert with a degree from Rochester Institute of Technology (RIT) in packaging science, Flynn got into packaging more typically. That is, in a roundabout way.
She was a pre-med chemistry major, but went to work for Firestone Tire & Rubber, where she acquired knowledge on elastomers and rubber manufacturing, before joining a West manufacturing facility producing elastomer components for pharmaceutical applications. Over 30 years she’s moved from R&D and quality control to the commercial side and her current role as president of Pharmaceutical Packaging Systems.
Flynn says West continues to recruit skilled workers from various fields. The company also works with Michigan State and other universities to provide intern opportunities for students. “Those who are packaging engineers,” she says, “are a hot commodity for sure.” West needs to talk with these students more than a year ahead of the company’s summer programs. “They’re interested in many different industries, so we’re competing across the board. After a positive intern experience, we hope to convince them to come work with us long-term.”
While there’s strong competition, Flynn doesn’t see a shortage of skilled workers. The challenge is to provide training once on board that is specific to the injectable pharmaceutical industry. West employs most of its packaging (and other integrated drug containment and delivery systems development) engineers from within the industry. But even these experienced workers require “on-the-job and industry-specific training throughout their careers.” She gives an example: “When you’re placing an elastomer component in direct contact with a drug that’s injected, it’s critical to have a deep understanding of the science of compatibility, and knowledge of quality expectations. There’s the need for very low levels of extractables to minimize the interaction between the drug product and the primary package.”
New Opportunities For Service Providers
A group of well-established, global providers with sufficient scale and broad industry presence currently provides Pharma with packaging systems. Like other parts of drug development and manufacturing, packaging is a risk-adverse industry. “Customers first want to know you have a track record of high quality and reliable supply chain manufacturing capabilities,” says Flynn. “This can make it somewhat difficult for new entrants supplying primary containment systems.”
Nonetheless, Flynn sees more new entrants on the delivery system side of the business, particularly as delivery systems and packaging are converging as a form of innovation in the industry. “This is a growing and not yet well established field,” she says. “But more drugs and changing demographics are lending themselves to advancements in this area. There’s the opportunity for companies to emerge with differentiated technologies and innovative solutions.”
West, which was a pure packaging company when Flynn joined, has taken this innovation track. In 2005, it acquired contract manufacturing capabilities and expanded into integrated drug delivery systems. And because innovation seems to lie in wedding packaging to the actual delivery systems for drugs, companies such as Becton, Dickinson and Company, specializing in syringe systems, Germany-based Gerresheimer, which focuses on glass systems, and Aptar Pharma (part of the international Aptargroup) in the nasal delivery arena, are all moving in the direction of combining and extending delivery solutions for pharma.
This line of innovation may also fragment the type of packaging delivery systems by company. “It’s still a rather unique model of integration,” says Flynn. “Industry leaders are emerging by establishing new systems for changing needs of clients and patients; there’s opportunity for future specialization considering new materials, user requirements, and even connectivity.”
Building In Quality And Innovation
We know that in any segment of the pharmaceutical industry, innovation has to fight with high standards of quality, and a good dose of risk-aversion. But as biologics and global injectable-drug markets grow, it becomes more important for Pharma to find ways to package and deliver drugs that can be administered outside of clinical settings, by caregivers and patients themselves. Pharma needs advancements ensuring the highest quality in the integration of these new delivery systems and packaging technologies … and it appears service providers are responding in kind.
Flynn reminds us this marriage of the primary package with the delivery system has become critically important from the user perspective. “It has to be patient-friendly: easy to understand and administer, and of the highest quality. You need to deliver the correct dose each and every time. It’s not just about a company developing good ideas. It’s being able to put those ideas into practice in a way that meets stringent customer, regulatory, and patient needs.”
Help with all this is coming via stronger industry-wide collaborations. For example, as an experienced provider of components for glass syringe manufacturers, West collaborates closely with these third-party companies to ensure systems work as intended. West also works with partners to ensure components perform optimally in the manufacturing process.
“Our industry now collaborates in a number of ways, whether with individual inventors and those in academia, or with other businesses wanting to partner to provide unique product and service combinations,” says Flynn. “We’re finding ways to combine ideas and capabilities, and bring innovation that maintains pharma and regulatory-mandated quality, on behalf of all patients.”