This year, INTERPHEX had something to prove: After years of declining attendance, are industry shows back to what they used to be now that the pandemic has been declared over?
Over the course of three days in April, Pharma Manufacturing editors explored the bustling trade show floor at the Javits Center in NYC and got a peak at what industry leaders have in mind for the future of pharma. On its first day, INTERPHEX 2023 was buzzing with energy. Entry lines wrapped around themselves several times, as hundreds of attendees eagerly made their way onto the exhibition floor.
“It's exciting to see all the vendors and engineering firms we work with, and to finally meet the people we've only talked to over the phone or Teams,” said Patrick Dorman, director of Automation at G-Con.
"As a concept, this show is vital for industry connection,” said Mike Martin, chief executive officer, CAI. “It pulls together providers of services and equipment, manufacturing providers who are the exhibitors, and clients. The connections don’t happen unless you're here.”
While the lines weren’t quite as long the following days, attendees remained engaged and eager to connect. Akin to years past, exhibitors say that the quality of leads made up for the lack of foot traffic.
“It's not to what it was before [COVID], but I had better quality of people and leads, not as many people, but I'd rather have better leads,” added Michael Staub, regional sales manager at Marchesini Group.
Key topics
FDA guidelines
With a heightened focus on technology compliance and evolving regulatory standards, professionals discussed the latest updates and strategies to ensure adherence.
“One of the trending topics is the new FDA draft guidance on computer software assurance [CSA], which allows industry to move away from the computer systems validation approach,” said Guarav Walia, senior global director of business development and principle SME in CSV/CSA/DI at PQE Group.
The draft guidance, issued in September 2022, spells out the agency’s expectations for computer systems used as part of medical device production or the quality system.
Walia, who gave a talk on the topic, explained that the approach ultimately helps companies cross the finish line faster. “Instead of doing a lot of testing in the documentation, the CSA approach focuses on attempting to understand what you're trying to achieve and then looking at what the quality aspects are to improve and limit adverse events for patient safety or product quality.”
The FDA has made it clear that it believes tech innovations such as AI/ML will play critical roles in drug development, stating plans to develop and adopt a "flexible risk-based regulatory framework that promotes innovation and protects patient safety." But drugmakers and device manufacturers are still looking for regulatory clarity.
“A lot of people are discussing AI and FDA guidelines for manufacturers, because that's going to have a bigger impact on the amount of paperwork that they need to submit for approval,” said Mariano Mattei, vice president of Cybersecurity at Azzur. “Whether its software driven or not, companies still have to protect their formulas and manufacturing processes."
Cell and gene therapies
With thousands of drugs in clinical development and market opportunities estimated at $58 billion over the next five years, it's no secret that the future of medicine will involve cell and gene therapies.
A key theme on the trade show floor was how expensive and complicated these therapies are to manufacture.
“There are discussions about cell and gene therapy and how to pay for it,” said Martin. “It's super expensive, but it cures people, and I am inspired by the science behind it and how we figure out how to cover its costs within our current health care system.”
High costs associated with production and distribution pose significant challenges in making gene therapies widely accessible and affordable to patients. A particular focus has been on optimizing manufacturing and standardizing product quality through automation.
“We’re hearing more and more conversations about commercial-scale self-tuning and 3D printing cells. It's a niche and vital area of both pharma manufacturing to become center point in the coming years,” said Sam Stoney, Life Sciences U.S. Industry Segment Manager at Festo. “I can't wait to see how we do it. Eventually, industry will have two or three standard ways that everybody does commercial cell culture, but we're nowhere near knowing what that standardized way is going to be."
Small batch processing
Paramount to the success of personalized medicine, is a need to streamline and optimize small batch manufacturing and continue to find ways to yield the most product from the tiniest of batches.
“The ability to get the highest amount of yield from a batch into good product vials and enter the market is key for us,” said James Rorke, vice president of North American Operations at Steriline. “Small batch processing is the talk of Interphex this year.”
Quick turnaround of high-value product is critical, especially in the CGT market. And vendors are rising to the challenge.
Laura Moody, director of Product Management, Pharma North America at Syntegon, explained, “Customers have very expensive products, and they want to make sure they can produce sellable vials or IV bags from their packaging process. Everyone wants to ensure we get as much sellable product as possible out of every batch, and we’re excited to help.”
One of the biggest misconceptions about small batch manufacturing is that it takes a long time between batches and that a lot of time is lost — a problem with which vendors are excited to help. “Our technology is focused on turning a line over quickly, not only processing a small batch but also going from batch to batch quickly with features like disposable filled tubing set technologies and a small number of change parts," Moody added.
Worth it?
When asked if the show had fully recovered to its pre-pandemic glory days, the crowd was divided.
Some said there hasn’t been too much progress in terms of numbers, “It's the same as last year, in terms of foot traffic, but conversations have been meaningful and engaging,” said Robert Conrad, sales director at Mettler Toledo.
Others noticed more people on the trade show, but still room for improvement. “This year has been a little bit better than last year, but there’s still a long way to go,” said Scott M. Kloetzer, director of Business Development at LJ Starr.
Overall, spirits are up, and attendees and exhibitors were hopeful. “I'm waiting for the numbers to come up, but I think soon we’ll be back to what we had in 2017, 2018,” said Sam Stoney, industry segment manager, Life Sciences U.S. at Festo. “I'm hearing this really feels like trade shows are back on their feet again.”
