As drug pipelines continue to expand and shift toward emerging biotech companies, the complexity of developing combination products has never been greater. In this episode of The Top Line, Kelly Hogan speaks with Dr. Bettine Boltres, director of scientific affairs, integrated systems at West Pharmaceutical Services, about how West Synchrony™ S1 prefillable syringe system was designed to address these growing challenges.
Dr. Boltres explains how fragmented supplier models create inefficiencies, duplicated testing and regulatory hurdles for pharma teams. By owning the entire prefillable syringe system, West provides a single point of accountability, complete design verification data and one comprehensive regulatory file, allowing developers to move directly into drug dependent testing and accelerate clinical progress.
The conversation also explores how system level specifications, batch release testing and global DMF coverage help reduce risk, shorten submission timelines and support global launches. Designed with biologics and modern vaccines in mind, West Synchrony enables drug developers to focus on what matters most: bringing safe, effective therapies to patients faster.
Speaker 3:
You're listening to a sponsored episode of The Top Line.
Kelly Hogan:
Welcome everyone. You're listening to The Top Line brought to you by Fierce Biotech. I'm your host, Kelly Hogan. Today I'm joined by Dr. Bettine Boltres, the Director of Scientific Affairs Integrated Systems at West Pharmaceutical Services. Bettine is recognized as the thought leader in the industry, known for fostering scientific exchange between West and the pharmaceutical sector. Welcome, Bettine.
Dr. Bettine Boltres:
Thank you very much, Kelly. Thank you very much for inviting me, and I'm very happy to be here.
Kelly Hogan:
So starting off, could you tell us the story behind the West Synchrony prefillable syringe system?
Dr. Bettine Boltres:
Yeah. So as a market leader, we've been monitoring the industry trends that inspired its development and saw that there was a need for innovation. So if you look at the drug pipeline, over the last 10 years or so, it has increased by almost three times, going from a little over 3,000 products to over 9,000 products today. And the really striking thing is that around 80% of these drugs are being developed by emerging companies versus the established pharmaceutical biopharmaceutical companies. So these emerging companies face huge challenges in developing their prefilled syringes based on the ever-increasing regulatory burden and the complexity of just being a combination product. And also the hospital to home trend has developed quite fast in the past years. And so we've seen a tremendous increase in innovation, and that's why we believe this is the right time to bring West Synchrony to market as a solution.
Kelly Hogan:
What are the standout features of the Synchrony PFS system?
Dr. Bettine Boltres:
Yeah. So the West Synchrony system offer, addresses several burdens that our pharma customers have to deal with as a result of today's fragmented and patchwork supplier environment for prefillable syringes. First and foremost, because we own the entire system, it provides a true single point of accountability and not only a single point of contact. And this will enable our customers to be much more efficient throughout the entire product lifecycle, in their development, but also post-launch. Another standout feature is that because we own the entire system, we obviously also have done the entire design verification ourselves. And this means that our customers don't have to repeat the drug independent testing anymore, because we give them all the data they need and they can jump right into the drug dependent testing. Also, because we own it, we were able to set up a system specification, especially for the critical aspects that should be evaluated on a system level. That is particles, silicon oil, endotoxin, and break loose and glide force.
And having these data for the individual components is nice, but not super relevant. So it's when they're provided for the entire system that the pharma company can really work with them. And that leads us to the next feature, which is a complete comprehensive singular regulatory file with a complete DMF for the entire system, again, because we own it. And this will help streamline the process and alleviate some of the work of drug developers so that they can focus on the development of a molecule, which is actually what they want to do, not the design of a syringe.
Kelly Hogan:
Why does it set a new standard in drug delivery?
Dr. Bettine Boltres:
The most obvious reason is that they're currently on the market. There is no real system out there, only components that are bundled together. So if you look at the market today, drug developers utilize individual components, which means they have to go out and search for each individual component. They have to discuss with the suppliers, order them individually, and generate their own DV data. Or the components are brought together as a bundle, but then they still must generate their own data, or pay the supplier for getting the data. With West Synchrony, they get all the DV data for free as they come as a natural part of the offering. And we already received a lot of good feedback on this from device developers all over the world stating that they've never seen that much of relevant information in one place anywhere else. And I think this really proves that we actually hit the nail on the head, and really did create a new standard.
And with West Synchrony, the work that we're doing and the data that we're providing, we give them the visibility of how the syringe system works truly as a system should, meaning that it functions based on the data that we're generating based on a batch to batch release basis. Remember, we have one specification for the entire system, and that truly is a new standard. And with the single US and Canada and China DMF and single regulatory package covering UMDR requirements, again, for the entire system, our customers will have a much easier time with global filings.
Kelly Hogan:
How does the new system help pharma companies streamline design and accelerate regulatory submissions?
Dr. Bettine Boltres:
Yeah. So if we first look at the development process, because we have done all the drug independent testing and provided to our customers, they can jump right into drug dependent testing. Also, we work together with CDMOs all over the world who have our system pre-qualified on their lines, so especially the small biotech companies, but also the large ones, can immediately start filling. And this significantly reduces time to clinical fill and getting to clinical data much sooner. And we all know that this is key if you want to be successful. And by eliminating the need to perform their own drug independent testing, they also achieve significant cost savings while having confidence in a fully proven, high quality, prefillable syringe. Then if we look at global launching preparations, our customers will get one document package for the entire DV data that they can use directly in their submission. So copy, paste, plus characterization data such as biocompatibility, extractables, and so on, for the entire system.
So they really get robust data at the system level, and this provides them with the necessary confidence that they haven't missed anything, and it significantly shortens the time and burden to put the ECTD together. And after all, this also saves money. And as the Tufts Center for the Study of Drug Development found, that every day of delayed launch could cost you around 500,000 US dollars. That can be quite a race. And lastly, by having one source of accountability, we can eliminate frustrating three-way CDAs and finger pointing between component suppliers and the fruitless search for answers. We all know the situation, we've all been there. For example, the pharma company has an issue with particles in their final product, and now where do they come from? How could we know? The investigation starts with contacting all suppliers and having individual discussions or setting up three-way CDAs where everyone is pointing at the other one.
With one system level specification for particles and batch release testing for particles, our customers have full transparency in what the system brings along in the first place. And this really saves a lot of time and resources and nerves especially. And really lastly, my really last point, with our smaller minimum order quantities, we also allow operations groups to manage their stock more efficiently and minimizing waste, which is important, considering the move towards more environmentally sustainable operations, right? And they can react faster to the volatile market demands with shorter lead times. So bottom line really is we create a dependable and economical source of supply for them while improving their financial position.
Kelly Hogan:
What are the benefits of a single supplier?
Dr. Bettine Boltres:
In the light of all the geopolitical discussions during the pandemic and several wars, regulatory agencies have put a higher focus on supply security. And in Europe with the new pharma legislation directive, for example, they require a shortage prevention plan. So creating a dependable source of supply is crucial. And the benefit of working with West is that we have multiple sources within our network for inventory so that we can reduce the risk to the supply chain. And with multiple production sites, we can alleviate any supply burdens. And by having multiple suppliers, you always have to juggle different lead times, order quantities, and individual delivery challenges, so this actually adds risk.
Kelly Hogan:
And finally, what types of products would benefit from the Synchrony PFS system?
Dr. Bettine Boltres:
So when we designed West Synchrony, we really designed it with both biologics and vaccines in mind. Of course, the biologics market is growing significantly, but we also see new developments in the vaccine space coming along that require a high quality prefillable syringe. So the benefits are geared toward biologics and modern vaccines, because we really believe that's where the greatest opportunity to help reduce risk and ensure patient safety aligns.
Kelly Hogan:
Thank you for a great conversation today, Bettine, and thank you for joining us on this episode of The Top Line. I'm your host, Kelly Hogan, and that's the bottom line from The Top Line.