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BIO 2025 - Political Climate Compilation

® Group was able to interview more than a half dozen executives in the biopharmaceutical industry 

 of the Biotechnology Innovation Association (BIO) International Convention, which took place in Boston June 16–19, 2025.

The conference was bookended by major developments with impacts to healthcare within United States government agencies, namely US Health and Human Services Secretary Robert F. Kennedy Jr. 

 of the Advisory Committee on Immunization Practices, a Centers for Disease Control and Prevention-affiliated body responsible for guiding vaccine policy, followed by 

FDA suspending certain new clinical trials,

 pending review, in which US citizens’ living cells are sent to China and other “hostile countries.”

With those policy and personnel changes in mind, the key opinion leaders shaping some of the content presented at BIO were asked how much attention they and their companies were giving to US developments, how those developments figured to impact their business, and the larger implications to their employees and the industry at large.

 in April, there was not one unifying theme expressed by this group; the changes—which by no means are complete—have affected companies small and large, as well as foreign and domestic, in varying ways.

Click the video above to view the responses that were compiled by PharmTech Group.

 is co-founder and chief executive officer, 


Brandon Pence is co-founder and chief operating officer, 

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

® group. As part of our coverage of the Biotechnology Innovation Organization International Convention in Boston in mid-June, we asked key opinion leaders and subject matter experts two questions across the board: To what degree are you keeping your eye on staffing, regulatory, and policy changes within US government agencies, and how do these shifts figure to impact your business? And—how else is the current US political climate impacting you, your company, and the industry overall? As we found out at the earlier INTERPHEX conference in the spring, uncertainty is still looming in the minds of many.

When you wake up every morning to see what's the news, how it's going to impact us. It definitely makes it hard to raise capital.

Depending on the size of a company and its location, some are adjusting their plans and processes, and others are not.

It almost helps to be a small company at this point where we're doing basic research and preclinical research, I don't think anything has changed from our plans based on the macro stuff that's going on right now.

It's definitely pushed us to be more efficient, much more efficient, definitely cutting all the fat that we can. We've had to sit down, review our goals, review our objectives; anything that drives us toward that, those goals, those value creation points, we keep doing. Anything that doesn't, doesn't.

For companies that don't have major operations in the US, they see opportunity,

While changes at the regulatory or federal level may affect how US companies approach partnerships, I believe our strong track records of collaboration with US clients, and the potential and economic stability of Poland and the EU, create a great opportunity for our region. With the right conditions, Poland can be become a key CDMO hub for American biotech, looking for reliable and cost effective partners in Europe.

For those that do business both here and overseas, they feel in general, they are in good position. And say these shifts are not unprecedented.

The way I look at it is, this is a remarkably important and resilient industry, you know, expand a variety of administrations, a variety of approaches.

The good news for Abzena is all of our manufacturing is based in the US, and so, you know, we're definitely seeing the tailwinds. It started with [the] BIOSECURE [Act], you know, in the previous administration; it's moved into a conversation around tariffs, and it's moved into a conversation around intellectual property protection, specifically in China.

FUJIFILM has done a great job of ensuring that it's insulated, in some regard, from various changes that might come up from some of these directives. We've got manufacturing footprints in multiple geographies. We're closely aligned with our customers and supporting their global needs.

Because our manufacturing is primarily in the US, our R&D services are in the UK, we've actually seen, you know, positive benefits from that side of it.

Since the spring, there's been a solid amount of turnover at FDA, both in personnel and policy, and there isn't any way that's gone unnoticed.

One of the areas that we continue to watch carefully is what's happening specifically [at] FDA, and you know, does drug development and approvals and things getting into IND [investigational new drug status], does that slow down because of some of the turmoil there? We haven't seen it yet, but we're certainly concerned about it and worried about it, because a lot of our customers are those early-stage companies.

It has to do with the FDA as well, and I think there are three aspects that probably impact us. One is the staffing changes at FDA, the regulatory agency. The second one has to do with drug pricing, and the third one with funding.

Will these changes slow innovation, especially at the university level? That remains to be seen.

We see, you know, the reduction of some of the, I'll say, funding that used to flow through some of these government agencies, into the universities that drove innovation. You know, a lot of these small companies get spun out of universities. That's worrying, that innovation could slow down, you know, if these grants that are coming through different parts of the federal government don't continue to go into the university systems, that it slows innovation in the US, and so we're obviously worried about that side of the policy. So, you know, there's always pros and cons with every administration, some of the things turn out to be positive, some of them not as much.

In [regards to] funding toward academic institutions, at the end, it's something that's going to impact all of us.

The bottom line has not changed: getting drugs into clinic, then getting them to market, as quickly, safely and effectively as possible.

There's always a question, how is that going to impact the path to the clinic for not only any drug, but in our case, for innovative and platform technologies. And what we've seen today, actually, they've been communicating the right message, that there's quite a bit of support for accelerated approval for rare diseases using validated endpoints that could make it easier, actually, to approve a drug therapy, a gene therapy, or an overall therapy for a rare disease. We want an effective and safe therapy, so that's what we mostly focus on.

Finally, a reminder of the US’s place in pharmaceutical development and hope that the country is able to stay there for the decades ahead.

So while we are certainly paying attention to the directives that are coming, we're listening to our customers, and we know that this industry that's been, you know, a strong growth agent for healthcare over the last 30 years, and will continue to be for the foreseeable future, is one that will require our participation with them.

We'll see what happens. I think people are nervous about some of the anti-science sentiment going on within the government right now, and just the fact that the US clearly has been the leader in biotechnology and pharmaceutical development over the last 50 years, no question. I think what people are nervous about is us, you know, actively giving up that lead and kind of abandoning that area of important high technology and, you know, letting other countries step into a leadership role there. I hope that doesn't happen, but I think that's what the industry at large is nervous [about], that we're going to move in that direction.

Videos

BIO International Convention

In contrast to earlier conferences in 2025, experts interviewed as part of the BIO conference in Boston did not come to a consensus about lasting impacts of recent changes in US government policy.

Key Leaders at BIO 2025 Respond to Continuing Political Shifts

UAE flag waving in the sky, national symbol of UAE | Image Credit: © Freelancer - stock.adobe.com

The Department of Health of Abu Dhabi, in the United Arab Emirates, said it has reached partnership agreements with Abbott, Boehringer Ingelheim (BI), and Sanofi, concurrent with a high-level delegation’s strategic mission to the United States from June 14–21, 2025 (1). This included a presence at the Biotechnology Innovation Organization (BIO) International Convention in Boston, from June 16–19, and visits to other major US cities including Philadelphia and Washington, DC (1).

Abu Dhabi signed MoUs with BI, Sanofi, and Abbott to expand vaccine R&D, local pharma production, and digital health capabilities.

BI’s OpnME platform access aims to enhance Abu Dhabi’s clinical research by providing compounds, networks, and collaboration tools.

Abbott’s pact focuses on localizing pharma manufacturing, biosimilar development, and advancing UAE’s digital health initiatives.

The intent of the mission, according to Abu Dhabi officials, is to reaffirm the Emirate’s position in worldwide healthcare innovation leadership, which the officials said is evidenced by its achievements in artificial intelligence, digital health, clinical research, and genomics—the latter area being one in which Abu Dhabi has said it is a leader in its global region (1). During the weeklong mission, the delegation planned more than 20 strategic meetings with both public and private sector leaders in the US for the purposes of exchanging knowledge and exploring investment opportunities.

“This mission reflects our commitment to shaping the future of health through collaboration, innovation, and shared purpose,” Her Excellency Dr. Noura Khamis Al Ghaithi, undersecretary of the Department of Health—Abu Dhabi, said in a press release (1). “Our vision is to build a health system that predicts, prevents, acts to restore, and acts to cure, therefore ensuring better outcomes for our communities and beyond. This can only be achieved through meaningful partnerships and a shared ambition to improve lives. We are proud to join our partners in the United States to explore new opportunities that advance healthcare, both in the UAE and globally.”

As the mission progressed, the Department of Health made headway on several alliances with major companies. The first, announced June 16, was the signing of a memorandum of understanding (MoU) with BI primarily concerning the granting of access to, and harnessing the capabilities of, BI’s OpnME platform, which makes use of four flagship programs to enable the research community to access advanced compounds, expert networks, and other support and collaborative opportunities (2).

On June 18, Abu Dhabi officials said they had signed another MoU, this time with Sanofi (3). Through this partnership opportunity, a press release said, the Emirate’s health-tech ecosystem and advanced research infrastructure will be leveraged to drive development of new global vaccines and strengthen regional vaccine manufacturing capabilities.

A third pact was disclosed on June 19, when Abbott agreed to localize manufacturing of pharmaceuticals in Abu Dhabi, and advance digital health solutions. The Department of Health said this would ultimately strengthen supply chain resilience and foster a healthcare ecosystem which is both sustainable and self-sufficient (4).

“Building on Abbott's long-standing commitment to the UAE's healthcare system, this partnership will focus on localizing existing pharmaceutical products, and jointly exploring the development of biosimilars, supported by regulatory alignment,” Mazen Bachir, regional director for Abbott's established pharmaceuticals business in the Gulf, Emerging Markets and Levant, said in a press release (4). “The collaboration also includes initiatives to digitize life science product information through electronic leaflets in alignment with the UAE's digital health strategy.”

All of our BIO 2025 coverage can be found at 

1. The Department of Health—Abu Dhabi. Abu Dhabi Reinforces Global Leadership in Healthcare Innovation with High-Level US Visit. Press Release. June 15, 2025.
2. The Department of Health—Abu Dhabi. DoH and Boehringer Ingelheim Ink Strategic Partnership to Advance Life Science Innovation Across the Emirate. Press Release. June 16, 2025.
3. The Department of Health—Abu Dhabi. The Department of Health—Abu Dhabi and Sanofi Forge Strategic Alliance to Accelerate the Development of New Global Vaccines in Abu Dhabi. Press Release. June 18, 2025.
4. The Department of Health—Abu Dhabi. 

The Department of Health—Abu Dhabi and Abbott Unite to Manufacture Pharmaceuticals Locally in Abu Dhabi.

Articles

The department’s newly announced partnerships were part of a weeklong visit that included discussions held at BIO 2025.

Abu Dhabi Department of Health Reaches Strategic Agreements During US Mission

BIO 2025: Pulmonary Drug Delivery

PharmTech Group spoke with Andy Burns, vice-president of MDI Business Development at Kindeva, about trends he is observing in the pulmonary drug delivery field as part of our preview of the BIO International Convention, which is being held from June 16–19, 2025 in Boston.

According to Burns, sustainability is a focus of a lot of pharmaceutical companies and stakeholders. “A lot of our clients and customers have their own well-developed set of policies and procedures that they wish their partner organizations to subscribe to, and certainly very progressive in Europe and the UK and also in the [United States],” Burns says. “So, sustainability and the impact on supply chains, both within Big Pharma, but also their associated contract manufacturers, is certainly a theme that I've seen developing over the past the past few years.”

Click the video above the watch the interview.

Andy Burns, vice-president of MDI Business Development at Kindeva.

PharmTech Group spoke with Andy Burns, vice-president of MDI Business Development at Kindeva, ahead of BIO 2025 to find out what’s new in pulmonary drug delivery.

A lab technician in protective gear operates a tablet displaying a green checkmark in a high-tech pharmaceutical laboratory. | Image Credit: © greenbutterfly - stock.adobe.com

® Group interfaced with nearly a dozen companies at the annual INTERPHEX conference in New York City on April 1 and 2, 2025, and while one of the overarching topics may have been the tariff policies of United States President Donald Trump’s administration—in which there were new developments during the event—many of the interviewees over those two days were eager to share their businesses’ latest innovations in manufacturing and how those might fit into the industry at large.

Most people interviewed did have at least one eye on what the Trump administration’s decisions might mean in terms of outsourcing, as best expressed by David Loula, global product director at ITT Engineered Valves.

“If you are procuring components [from] or some of your supply chain is based, for example, in China, you’ve seen a recent increase in tariffs on components coming out of China that has a direct impact on our costs, and it’s something that we have to decide as to whether we’re going to pass those costs along to our customer base, or we’re going to eat those costs ourselves,” Loula said. “You don’t always know if the steel components that you’re buying have metals that were sourced in one of the target countries. So that one’s a little trickier to figure out, but we’re working closely with our supply chain to identify which of those items might have direct impact on our cost position.”

Beyond those concerns, however, three main manufacturing themes emerged: safety, sustainability, and the rise of artificial intelligence (AI) and automation.

Joe Bobacher, regional sales manager for OPW Engineered Systems in Hamilton, Ohio, spoke to PharmTech Group about preventing spills in the manufacturing process, which all companies would like to ideally avoid in order to not lose product, but also to prevent anything corrosive from leaking into the environment.

“As safety evolves throughout manufacturing process facilities where you have fluid transfer, spill prevention is very important,” Bobacher said (2). “So, we find that companies are looking to reduce the amount of spills at a site because a lot of facilities and processes have that fluid transfer and the products that we supply.”

One category that has increased in popularity in recent years is single-use equipment, technologies, or entire systems, a trend noted by Todd Andrews, global director of Applications and Business Development for the Biopharma business at CPC.

When it comes to safety, Andrews said single use used to be a “wild wild West” where everyone wanted a customized solution. This was a complex problem, he said, and stressed the supply chain because manufacturers were often stuck making different assemblies for the different demands of their various customers. But these suppliers have since adapted.

“What we’re seeing now is a lot of forward-thinking end users trying to break up—we call it ‘break up the octopus’,” Andrews said. “Instead of this giant tubing assembly, how do you break it up into the common subassemblies? And you almost can treat it like a Lego, where you may have a ‘T’ or a cross and you can basically customize at the point of use, instead of customizing with the OEM [original equipment manufacturer]. And if you’re an OEM supplying this, this adds a lot more efficiency, because now, instead of making lower volumes of multiple part numbers, you can make higher volumes of lower part numbers.”

Pharmaceutical Technology®/Pharmaceutical Technology® Europe/BioPharm International

When referring to this article, please cite it as Lavery, P. Companies Reveal Their Next Moves in Manufacturing. 

INTERPHEX

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.

Companies Reveal Their Next Moves in Manufacturing

CPHI Americas 2025 Interview - Christy Eatmon

As part of its coverage of CPHI Americas 2025, which was held in Philadelphia from May 20–22, 2025, 

® interviewed Christy Eatmon, global subject matter expert for Sterile Drug Products at Thermo Fisher Scientific, about the company’s presence at the event, and some of its latest ventures including the Accelerator Drug Development services that Thermo Fisher rolled out in the fall of 2024.

Also included in the discussion was Thermo Fisher’s contract development and manufacturing organization (CDMO) perspective on world events in 2025 and how they relate to the pharmaceutical industry, particularly higher global tariffs and the emergence of more widely used and available smart technologies such as automation and artificial intelligence (AI).

“I think in the past, CDMOs functioned as ‘just the hands,’ just a manufacturing house. Now we really want to partner with our customers,” Eatmon says in the interview. “We want to be the trusted partner, the team that’s bringing innovation to the market. We have added some aspects of AI to our processes. One of those to know, especially on the drug product side, is that we’ve integrated AI-assisted inspection. This is for large-scale commercial programs right now, but basically, we have a module where we’ve been able to decrease rejects, improving our yields, and then also using very expedited, very fast automated visual inspection—as every serial product, every unit, needs to be inspected, either by person, manually, or automated by a system of cameras.”

Click the video above to watch the full interview.

, where she and other representatives of CDMOs across the industry discuss the changing nature of outsourcing models.

Christy Eatmon of Thermo Fisher Scientific reviewed her company’s experience at CPHI Americas 2025 and discussed recent industry trends that are driving strategic partnerships.

CPHI Americas 2025: The Evolving Role of the CDMO

A doctor in a white lab coat shaking hand showing symbol of medicine innovation, treatment, discovery and healthcare analysis. | Image Credit: © chadchai - stock.adobe.com

 felt by many subject matter experts and key opinion leaders in the bio/pharmaceutical industry as the tariff policies of United States President Donald Trump's administration became a dominant topic of discussion at INTERPHEX 2025, held from April 1–3, 2025 in New York City.

These changes figure to shape what partnerships, and which types of partnerships, companies seek in R&D, manufacturing, commercialization, and other areas of the drug product lifecycle over the next several years.

What follows is a recap of some of those company representatives’ opinions, speculations, and in some cases, even preemptive plans to tackle a landscape that may not yet have definitively changed, but may be constantly shifting sooner rather than later.

Widespread uncertainty over evolving US tariff policies is delaying capital projects and supply chain decisions across the pharmaceutical sector.

Tariff impacts vary widely—US-based firms see supply-side disruptions, while foreign companies fear reduced access to US partnerships and markets.

Policy-driven incentives may accelerate domestic pharmaceutical manufacturing and automation, but progress hinges on clearer long-term guidance.

William Wainwright, business development manager at Iwata Label USA, a division of Japan-based IL Group, 

 many in the industry are feeling—a sense of not quite knowing what might come next.

“It's obviously a very dynamic situation, and it's changing quite daily, sometimes by the hour,” Wainwright said (1). “Definitely, if the tariffs do stick long-term, the business will have to adjust to that. But I think a lot of players in the industry are waiting to see if and how long the tariffs are going to stick around. Because, as we've seen ... they're there, they're not there, the percent is changing. Obviously, all that goes into the calculus.”

Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, 

 a slowdown of sorts in the progress of new projects.

“The biggest impact is the uncertainty, because we are in a capital investment world,” Murphy said (2). “Many companies, it would appear at the moment, are taking a wait-and-see attitude. Many projects are starting to become delayed, maybe pushed back, until it's understood what the environment is.”

A dichotomy emerged in these interviews, between the outlook of those companies based in the US and those that are not. Chris Gooding, general manager at CRL Solutions of Red Wing, Minn., said he 

did not anticipate his business would be significantly impacted

 in the near term, but did say that it does not operate entirely in a vacuum.

“The way that our products are made, as a government contractor, we source everything locally in the US, so for any of our US customers, obviously there's no impact,” Gooding said (3). “As we export and things change, there could be an impact there ... Like everybody else, I'm trying to see how this unfolds, but as of today, everything that we do is sourced through the US suppliers.”

 co-founder and CEO of RheaVita, which is headquartered in Ghent, Belgium. But de Beer’s concern was 

“This is all pretty new for us, as a European company,” de Beer said (4). “It creates some uncertainty for pharmaceutical manufacturing innovation. Some substantial savings are done toward the regulatory authorities, [and the] pharmaceutical industry, they need the regulatory authorities to support their innovation. So hopefully, these savings toward the regulatory bodies are not, let's say, limiting or making innovations slower. And of course, we also strongly hope that these tariffs will not scare American companies to invest in European technologies, which are also very beneficial for American companies.”

 head of Sales for Automation NTH, and David Loula, global product director for ITT Engineered Valves, noted their respective companies’ positions as US-based businesses that rely, or may rely, on foreign equipment, and the relationships they must foster to procure what they need.

“The biggest impact right now is on our ability to price components and lead time for things,” Sarvey said (5). “We do final assembly, and everything is designed and built, here in the States for Automation NTH; we're based in [the] Nashville, Tenn. area. But a lot of the components that we get, whether it be raw materials, aluminum, steel, or even electronic components like sensors or cord sets or even cameras or robots, are coming from overseas. So we have to make sure that we've got language in our proposals to say that although this might be the price right now, and this is the lead time right now, in 30 days that might change. It's been hard to hold on to that price and lead time for a longer period of time. It hasn't affected our design or what we use yet. So right now, it's just a little bit of uncertainty of, how quickly can we come to a solution with one of our customers or clients, and can they make a decision on it? And a lot of times on large capex [capital expenditure] purchases, it's a longer decision period, so the price is just in flux.”

Given the present rise in smart technologies, artificial intelligence, and the like, Sarvey said he is observing an effort to 

“Long-term, we have seen a few companies that are our customers that are reaching out to look at automated manufacturing stateside, where they had been producing the parts overseas,” he said (5).

Loula was already looking specifically at some of the most prominent countries the Trump administration had prioritized setting its sights on, China, Canada, and Mexico, in trying to assess 

how US manufacturers would act going forward.

“There's a lot of puts and takes that are taking place ... If you are procuring components or some of your supply chain is based, for example, today in China, you've seen a recent increase in tariffs on components coming out of China that has a direct impact on our costs, and it's something that we have to decide as to whether we're going to pass those costs along to our customer base or we're going to eat those costs ourselves,” he said (6). “The tariffs that are being applied to Canada and to Mexico and some of the other countries where other metals are being imported has almost more of an indirect implication on cost, because you don't always know if the steel components that you're buying have metals that were sourced in one of the target countries. So that one's a little trickier to figure out, but we're working closely with our supply chain to identify which of those items might have direct impact on our cost position.”

 from higher tariffs imposed by the US, said 

 co-founder and CEO of the biotechnology company Sunflower Therapeutics.

“I think if we think about the impact that it potentially can have on, for example, the biologics industry here, it provides not only an opportunity, but a strong incentive to onshore manufacturing, and potentially to actually do it in a way that, combined with automation, can create kind of the facility of the future,” Love said (7). “That's more of a distributed manufacturing concept, or a micro facility like we're seeing revolutionize the electric vehicle space or new textiles or food production. I think it's time that we think about how this could be a driver for us to do something similar for protein and biologics production.”

Murphy agreed that the policies could indeed lead to a business boom, but worried that progress was being halted as companies formulate responses and action plans that fit their unique needs.

“If the practices are successful in onshoring more manufacturing, then it could eventually be a net gain for our business and additional facilities being constructed,” Murphy said (2). “But at the moment, it just seems that many projects are being held while people are trying to determine what their spending model will look like.”

Similarly, although de Beer had expressed some doubt about the pace of innovation continuing at a robust clip, he said the changing tides don’t mean companies should stop developing themselves and their offerings entirely, or seeking out new and useful partners.

“Today, I would say there is some uncertainty,” de Beer said (4). “But on the other hand, I think we as innovative companies should also try and think on how to deal with that. And I think we should stay positive.”

Sarvey, meanwhile, attempted to put the US government’s intentions for the pharmaceutical industry in perspective.

“The end goal, I'd have to imagine, is to bring that manufacturing back,” Sarvey said (5). “It is a journey. It's a many-year journey. But we are seeing a few signs of opportunities where a company that was manufacturing elsewhere is interested in what a concept for an automation line would look like stateside. So, that's kind of the two ends of the spectrum.”

As alterations in US policies continue, so will pharmaceutical partnerships. However, the full impact of these changes may not be seen by the end of the current Trump term, and could have the potential to outlast it by years or more.

INTERPHEX 2025: How Functional Labeling Can Protect Parentals in Vials and Syringes.

, April 1, 2025.
2. Lavery, P. and Mirasol, F. 

INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing.

, April 2, 2025.
3. Lavery, P. and Haigney, S. 

INTERPHEX 2025: Beta Bags and Sterile Manufacturing.

, April 3, 2025.
4. Lavery, P. and Haigney, S. 

INTERPHEX 2025: Continuous and Controlled Freeze-Drying.

, April 2, 2025.
5. Lavery, P. and Haigney, S. 

INTERPHEX 2025: AI and Automation in Pharma.

, April 2, 2025.
6. Lavery, P. and Mirasol, F. 

INTERPHEX 2025: Innovations in Advanced Sensing Technologies that Answer the Need for Reliable Valve Function.

, April 3, 2025.
7. Lavery, P. and Haigney, S. 

INTERPHEX 2025: Automation for Protein Manufacturing.

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

Geopolitical Shifts Change Nature of Pharma Partnerships

AAPS National Biotechnology Conference 2025: High-Concentration Biologics

Biologic drugs typically have a higher dosage than small-molecule drugs, according to Lun Xin, associate director at WuXi Biologics, and sometimes patients will need to spend hours at an infusion center to receive these treatments. “That's a growing experience for a lot of people, especially folks that [are] dealing with things like cancer or long-term arthritis disease or something of that nature, which is lot of time … So, there's a good amount of need for a patient to take [the drug] home and then be able to use pre-filled syringes or autoinjector cartridges, where they can deliver the dose by themselves in the comfort of their home,” says Xin. “Now the limitation with that is you can only put in so much drug into the subcutaneous space using a prefilled syringe or auto injector. And a lot of that's believed to be about two milliliters to be a good benchmark. So now that you have the ideas, and you have to deliver several 100 milligrams of those into a two milligram, two milliliters of volume, right? So, there's a need to develop the concentration of the protein therapeutics to several 100 milligram per mL.”

 spoke with Xin about these challenges associated with the formulation of high-concentration biologics ahead of his presentation at the AAPS National Biotechnology Conference, which is being held May 4–7, 2025 in Boston. Xin’s presentation, “Accelerating High Concentration Formulation Development with Big Data-Driven High-Throughput Technologies”, occurred on Tuesday, May 6 .

Click the video above to watch part one of our interview with Lun Xin.

Lun Xin is associate director at Wuxi Biologics.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.

AAPS National Biotechnology Conference 2025: AAV Vector Production

Adeno-associated virus (AAV) vectors are commonly used for gene therapies, according to Noah Kopcho, field application scientist at Gyros Protein Technologies. AAV vectors come with challenges in productions, however. “Namely, compared to other vectors, AAV often has lower titers,” says Kopcho. “This can present problems with scalability. During the production and purification workflow, there are several different contaminants that need to be kept in mind, and purity is often essential. And at the at the end of the workflow, you know all of these measurements that need to be made can present several different bottlenecks that that can be very time consuming and can often eat into efficiency.”

 sat down with Kopcho to find out how these challenges can be overcome. Click the video above to watch the interview.

Kopcho’s spoke on this topic at the AAPS National Biotechnology Conference 2025, which is happening May 4–7, 2025 in Boston. His presentation, “

Accelerate Development of AAV-based Gene Therapies with Automated Viral Vector Titer and Impurity Analysis

Noah Kopcho is field application scientist at Gyros Protein Technologies.

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

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GSK is preparing to present data from its respiratory portfolio in more than 40 abstracts at the 2025 edition of the American Thoracic Society (ATS) International Congress, which will be held in San Francisco from May 16–21 (1).

Among a list of 43 scheduled abstracts, including four late-breaking submissions, GSK in a press release on May 2, 2025 offered details on 26 “key presentations” to be made at the event, five of which will be given orally (1). This group of presentations, GSK said, will largely focus on optimal patient care that facilitates prevention and treatment of diseases such as asthma and chronic obstructive pulmonary disease (COPD).

Two of the treatments that will be receiving plenty of attention in GSK’s presentations are mepolizumab and depemokimab, which are both monoclonal antibodies (mAbs) that target IL-5, a key cytokine or messenger protein in asthma with type 2 inflammation. Phase III trials (MATINEE for mepolizumab and SWIFT-1 and SWIFT-2 for depemokimab) have assessed the efficacy and safety of their respective medications in treating type 2 inflammation and, in mepolizumab’s case, COPD (1).

Mepolizumab is currently approved for use in the United States and Europe across four IL-5 mediated diseases, but not for treatment of COPD. Depemokimab is an investigational product that has not yet been approved for use in any country, according to GSK (1).

Meanwhile, GSK has received approvals for several treatments in other areas so far in 2025.

In April 2025, the United Kingdom’s Medicines and Healthcare products Regulatory Agency 

 (brand name Blenrep), an antibody-drug conjugate that comprises a humanized B cell maturation antigen mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker, for treatment of adults with multiple myeloma in either of two combinations: with bortezomib plus dexamethasone for patients who have received at least one prior therapy, and with pomalidomide plus dexamethasone for those who have received a prior therapy including lenalidomide (2). Prior to that, in February, FDA 

 for meningococcal disease groups A, B, C, W, and Y, marketed as Penmenvy, for use in individuals aged 10 through 25 in the US (3).

GSK has also announced numerous partnerships and collaborations since the fourth quarter of 2024: 

 with the University of Cambridge and Cambridge University Hospitals to treat immune-related diseases with existing as well as newly-developed therapies, particularly kidney and respiratory diseases; 

 with Relation, a UK-based platform biotechnology company, for the identification and validation of novel therapeutic targets for fibrotic diseases and osteoarthritis, and Muna Therapeutics, a Denmark-based biotech, to identify and validate novel drug targets for the treatment of Alzheimer’s disease; and 

 with the University of Oxford that will focus on the potential of cancer prevention through vaccination (4–7).

1. GSK. GSK Continues to Advance the Future of Respiratory Medicine and Patient Care with New Data at ATS. Press Release. May 2, 2025.
2. GSK. Blenrep (belantamab mafodotin) Combinations Approved by UK MHRA in Relapsed/Refractory Multiple Myeloma. Press Release. April 21, 2025.
3. GSK. Penmenvy, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY. Press Release. Feb. 15, 2025.
4. GSK. GSK and Cambridge University Announce New Five-Year Collaboration in Kidney and Respiratory Disease. Press Release. Oct. 21, 2024.
5. Relation. Relation Announces Two Strategic Collaborations with GSK to Advance Therapeutics for Fibrotic Diseases and Osteoarthritis. Press Release. Dec. 10, 2024.
6. Muna Therapeutics. Muna Therapeutics Announces Strategic Alliance with GSK to Accelerate Development of Novel Treatments for Alzheimer’s Disease. Press Release. Dec. 5, 2024.
7. GSK. GSK and Oxford Establish the GSK-Oxford Cancer Immuno-Prevention Programme to Advance Novel Cancer Research. Press Release. Jan. 27, 2025.

The company is presenting data related to its medications designed to advance the prevention and treatment of asthma and COPD.

GSK Previews Oral and Poster Abstracts for ATS International Congress

Thousand Oaks, Calif.-based Capsida Biotherapeutics (Capsida) has announced its slate of seven scientific presentations, three oral and four in poster form, that have been accepted for the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), which will be held in New Orleans from May 13–17, 2025 (1).

In a press release, Capsida said the presentations would show new data demonstrating the company’s positive progress across its wholly owned pipeline, proprietary capsid engineering, and manufacturing (1).

More specifically, the three oral presentations will highlight advances in Capsida’s intravenously (IV)-delivered genetic medicines—including its first-in-class IV administered gene therapy CAP-002, designed to achieve brain-wide neuronal expression while simultaneously detargeting the liver—which are enabled by the company’s engineered capsids and cargo (1,2).

The first, to be presented by Celeste Stephany, PhD, Capsida director of CNS (central nervous system) and Ophthalmology Preclinical Research, is entitled “Systemic AAV (adeno-associated virus) Gene Therapy with Next Generation Engineered Capsid Demonstrates Expression Levels Supporting Potential Therapeutic Benefit for CNS, Cardiac, and Sensory Symptoms in Friedreich’s Ataxia” (1). The second is closely related: “Systemic Gene Therapy CAP-002 Demonstrates Potential for Disease-Modifying Treatment of Seizures and Motor and Cognitive Deficits of STXBP1-DEE Using an Engineered, CNS-Targeted AAV,” to be presented by one of Capsida’s founders and Chief Research and Innovation Officer Nick Flytzanis, PhD.

A third oral presentation will be made by founder and Chief Technology Officer, Nick Goeden, PhD, entitled “Identification of Multiple Novel Blood-Brain-Barrier Receptors for CNS Gene Therapy and Other Drug Modalities via an Integrated AAV Capsid Engineering Platform” (1).

All oral presentations will be made on Wednesday, May 14, as will two of the four poster presentations; the other posters will be exhibited during evening sessions on Tuesday, May 13 and Thursday, May 15 (1). Capsida said the data contained in each presentation will be embargoed until the morning of May 13 for posters, and the morning of May 14 (the presentation day) for oral sessions.

“These data reflect the significant progress we are making in translating Capsida’s innovative capabilities into differentiated clinical therapies,” said Peter Anastasiou, Capsida chief executive officer, in an April 28, 2025 press release (1). “We are on track to enter the clinic with our STXBP1-DEE and PD-GBA programs this quarter, with the potential to bring disease-modifying and possibly curative treatments to these communities who so desperately need them.”

Capsida presented preclinical evidence for CAP-002 

“This study built upon our previous proof-of-concept study and represents a significant advancement in our understanding of the therapeutic potential of engineered AAV gene supplementation therapy in the treatment of genetic epilepsy and developmental disorders due to STXBP1 mutations. These data are encouraging and emphasize the potential for CAP-002 to meaningfully improve outcomes in patients with this disease,” Mingshan Xue, PhD, associate professor, Department of Neuroscience, Department of Molecular and Human Genetics at Baylor College of Medicine and the Cain Foundation Laboratories, Jan and Dan Duncan Neurological Research Institute at Texas Children's Hospital and an ASGCT 2024 presentation co-author, said at the time (2).

1. Capsida Biotherapeutics. Capsida to Present Progress Updates at the ASGCT Annual Meeting, Including NHP GLP Toxicology Study Results for its Potential First-in-Class STXBP1 Developmental and Epileptic Encephalopathy Program (CAP-002 STXBP1-DEE). Press Release. April 28, 2025.
2. Capsida Biotherapeutics. Capsida Biotherapeutics Presents New Preclinical Evidence Indicating Novel First-in-Class IV-Administered Gene Therapy Effectively Treats Genetic Epilepsy Due to STXBP1 Mutations. Press Release. May 7, 2024.
3. American Society of Gene & Cell Therapy. ASGCT Annual Meeting. 

Conference

The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.

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