Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Mike Hennessy Jr. is the Chairman and CEO of 

High Angle Shot of a Working Desk of an Successful Person in Office with Cityscape Window View. | Image credit: © Gorodenkoff - stock.adobe.com

Progress in biopharmaceutical science is happening at a pace that challenges even the most seasoned professionals to keep up. This issue of Pharmaceutical Technology® brings that momentum into sharp focus, offering readers a roadmap through scientific breakthroughs, operational innovation, and the cultural shifts required to deliver tomorrow’s medicines.

Our cover story, “Advancements in Biopharma Spur Industry-Wide Innovation,” looks at how messenger RNA platforms, cell and gene therapy pipelines, multispecific antibodies, and extracellular vesicle therapeutics are reshaping the commercial landscape. Thought leaders predict a future in which no single modality dominates; instead, diverse targeted options will coexist, forcing manufacturing and regulatory models to evolve quickly.

Building on that science, the Development feature, “Achieving Targeted Delivery with Nanoscale Systems,” details how lipid, polymeric, and biomimetic nanocarriers are boosting bioavailability and enabling combination therapies.

Downstream on the factory floor, our Manufacturing Q&A with ACG Packaging Materials’ Sheikh Akbar Ali, PhD, illustrates how digital printing techniques, solvent-free adhesives, and advancements in single-use packaging are helping manufacturers meet productivity goals and prioritize sustainability.

As always, quality and compliance remain front and center. Our Pharma Fundamentals feature, “ICH Q6B for Analytics” translates the quarter-century-old guideline into today’s high-resolution mass spectrometry workflows, clarifying expectations for primary sequence confirmation, glycan profiling, and disulfide mapping. Meanwhile, the Outsourcing feature delves into how artificial intelligence and “hybrid” contract and development organzanizations are redefining sponsor relationships amid geopolitical supply chain pressures.

This issue’s Ask the Expert series dives into the PDA/ANSI Standard 06-2025, offering practical advice for embedding leadership accountability, employee engagement, and technical excellence into an enterprise-wide quality culture.

Together, these articles underscore a central message: success in 2025 demands not only cutting-edge science, but agile operations and a values-driven culture that keeps quality at its core.

Mike Hennessy Jr is Chairman and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Driving Advancement Through Scientific and Operational Innovation. 

Articles

Scientific breakthroughs, operational innovation, and cultural shifts are driving tomorrow’s medicines.

Driving Advancement Through Scientific and Operational Innovation 

Piramal Pharma Limited

One of the most recent changes at Piramal Pharma Limited is the expansion of its U.S. facility, doubling sterile fill-finish capacity and adding commercial-scale lyophilization to meet growing demand for U.S. containment and antibody-drug conjugate (ADC) support. The company has also enhanced its Science Collective by onboarding senior leaders in discovery and small molecule chemistry, enabling deeper technical collaboration with clients across modalities such as peptides, small molecules, and ADCs. Lastly, their global sustainability and digitalization initiatives have shifted to support future AI-driven manufacturing and quality solutions.

How Piramal as a leading global CDMO is expanding to meet market demands and patient needs

Their seamless integration of facilities and expert team of industry leaders, enabling them to provide comprehensive services across the entire drug life cycle

The role of patient centricity at the heart of their operations, with a goal to reduce the burden of disease for patients worldwide

Videos

Peter DeYoung, CEO at Piramal Pharma Limited, explains how Piramal is meeting the growing demand for integrated biologics manufacturing by expanding capabilities and expertise. 

From Discovery to Delivery: How Piramal Pharma Limited is Strengthening its Drug Development Capabilities

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Adeno-associated virus (AAV) vectors have become widely used as delivery mechanisms in gene therapy, but there are some complex hurdles to be overcome. In this episode of the Drug Solutions podcast, Patrick Lavery, editor for 

®, surveys two attendees from the recent ASGCT conference about their approaches, the results they have achieved so far, and what further research or investigation might be needed to bring these therapeutic tweaks to a wider cross-section of patients.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.

Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries

A CDMO’s Role in API Quality

Contract development and manufacturing organizations (CDMOs) can offer services across different modalities and, often, across different regions, according to Martin Meeson, CEO of Axplora. CDMOs also audit their ingredient suppliers to ensure quality. These services can help ensure API quality, thereby helping to secure the supply chain.

“We look to [our suppliers] for the same commitment to quality that we have. In order to apply that across the supply chain, we have to have a structure like this, because you have to be quite agile in the industry that we've got. We're all people [who] want speed, reliability, and quality built in,” Meeson says. “But we have to find a way to have a supply chain that's robust and can operate with a little bit of agility to make sure that we can get the medicines through to the patients that we supply. I think [being science based] is a really important part of underlying quality. It is a very technical piece of operation we do to have that level of science embedded.”

Meeson recommends that pharmaceutical companies partner with companies that have quality embedded into their operations. “It's not something that we turn off; it's absolutely embedded in everything that we do, in every piece of day-to-day operation. It's absolutely the heart of what we do every day,” Meeson says. “This is exactly what [pharma companies] should be looking for, because that ensures the robustness of the supply of the medicines that we are making for the patients that are out there.”

Click the video above to watch the interview.

Pharmaceutical Technology® spoke with Martin Meeson, CEO of Axplora, about the role contract development and manufacturing organizations have in ensuring the quality of APIs and the security of the supply chain.

Teva Pharmaceuticals manufacturing site. Locally, Teva produces oral solid medicines and packaging. | Image Credit: © jetcityimage - stock.adobe.com

 announced on May 27, 2025 that its investigational anti-interleukin-15 (IL-15) antibody, TEV-53408, has been granted Fast Track status by FDA (1). The treatment is intended for people with celiac disease who are on a gluten-free diet.

Such a diet—which must be kept strictly and lifelong—is currently the only treatment for celiac disease, a chronic, autoimmune disorder that is triggered by gluten and results in a range of mostly gastrointestinal symptoms (1). TEV-53408 is being evaluated at present in a Phase IIa trial in order to assess its safety and efficacy in adults with celiac disease.

Teva’s TEV-53408, an anti-IL-15 monoclonal antibody for celiac disease, has received FDA Fast Track status, supporting faster development and review.

The drug targets IL-15 to help prevent intestinal damage in patients with celiac disease who are already on a strict gluten-free diet.

This news follows Teva’s recent biosimilar launch with 

 and highlights industry momentum around autoimmune and rare disease therapies.

“FDA’s decision to grant Fast Track designation for TEV-53408, an investigational anti-IL-15 antibody therapy, reflects the promising nature of the treatment and the urgent unmet need of people living with celiac disease,” said 

 MD, PhD, executive vice president, Global R&D and chief medical officer at Teva, in a company press release (1). “Teva is driven by a commitment to innovation and this latest achievement gets us one step closer to providing promising, innovative treatment options for patients with chronic autoimmune diseases like celiac disease.”

TEV-53408 is a monoclonal antibody intended to inhibit the activity of the cytokine IL-15, in order to prevent intestinal damage and other symptoms associated with celiac disease, which affects approximately 1% of the global population (1).

In April 2025, Teva Pharmaceuticals, the US-based affiliate of Teva Pharmaceutical Industries, made another significant announcement for the company, saying that it was 

 to launch eculizumab-aagh (under the brand name EPYSQLI), a biosimilar referencing eculizumab (brand name Soliris) (2). Eculizumab-aagh was approved by FDA in July 2024 to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as in November 2024 to treat generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive, all difficult-to-treat rare diseases. The biosimilar is being offered at a 30% discount of the Wholesale Acquisition Cost of the reference biologic (2,3).

 this one to a human anti-IL-7Rα antibody, bempikibart (ADX-914) made by Q32 Bio of Waltham, Mass., for the treatment of alopecia areata, a common, autoimmune skin disease characterized by hair loss, often in circular, coin-like patches, on the scalp as well as other areas of the face and body (4,5).

Fast Track status was designed by FDA to facilitate development and expedite review of certain drugs that are being formulated to treat serious conditions, addressing previously unmet medical needs (1).

Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA.

 Press Release. May 27, 2025.
2. Teva Pharmaceutical Industries. 

Teva and Samsung Bioepis Announce Biosimilar EPYSQLI (eculizumab-aagh) Injection Now Available in the United States.

 Press Release. April 7, 2025.
3. Mirasol, F. 

Teva and Samsung Bioepis Launch Biosimilar Eculizumab in US Market.

Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata.

 National Alopecia Areata Foundation | NAAF. 

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.

FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

GSK signage, logo, emblem on the facade, British multinational pharmaceutical and biotechnology company. WARSAW, POLAND - JUNE 3, 2023 | Image Credit: © OlekAdobe - stock.adobe.com

 announced on May 28, 2025, that a Phase III trial (PIVOT-PO)—evaluating the investigational oral treatment tebipenem HBr for complicated urinary tract infections (cUTIs), such as pyelonephritis—will be stopped early for efficacy based on the recommendation of an Independent Data Monitoring Committee (IDMC) (1). The IDMC review did not identify any new safety concerns beyond those identified in previous studies of tebipenem, with diarrhea and headache listed as the two most common adverse events.

The recommendation was based on a planned, interim data analysis of the nearly 1700 patients enrolled in the study (1). GSK said that the trial met the primary endpoint of non-inferiority of tebipenem HBr, compared with intravenous imipenem-cilastatin, in hospitalized adult patients with cUTIs including pyelonephritis.

“We’re proud of today’s positive result for patients diagnosed with cUTI, includingpyelonephritis, where oral treatments are much needed,” 

 chief executive officer of Spero Therapeutics, said in a GSK press release (1). “We look forward to working with GSK on next steps for tebipenem HBr, and would like to thank the patients, investigators, and other clinical staff who have participated in PIVOT-PO trial to reach this advanced stage.”

In the United States, an estimated 2.9 million cases of cUTIs are treated annually (1). The current standard-of-care includes intravenous carbapenem antibiotic treatment; if approved, tebipenem HBr would be the first oral carbapenem antibiotic available in the US.

“Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock,” 

 GSK chief scientific officer, said in the release (1). “Currently many need hospital-based intravenous treatment due to limited oral options for drug-resistant infections, contributing to over $6 billion per year in US healthcare costs. These positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home.”

Developments on several other fronts at GSK were presented 

 at the American Thoracic Society International Congress, held in San Francisco from May 16–21, 2025 (2). This group of presentations, GSK said in a preview of the event, largely focused on optimal patient care that facilitates prevention and treatment of diseases such as asthma and chronic obstructive pulmonary disease.

GSK said it plans to work with US regulatory authorities to include the data from the PIVOT-PO trial, up to when it was stopped on the IDMC’s recommendation, later in 2025 (1). Full results are planned to be submitted for presentation at an upcoming scientific congress, and for publication in a peer-reviewed journal, but GSK did not specify in the press release which events or publications were being targeted.

PIVOT-PO Phase III Study for tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee.

GSK Continues to Advance the Future of Respiratory Medicine and Patient Care with New Data at ATS.

Both companies viewed the early end to the PIVOT-PO trial as a positive development, with GSK saying it would work with US regulatory authorities to move the treatment forward in 2025.

GSK, Spero Therapeutics Oral UTI Treatment Trial Stopped Early for Efficacy

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. 

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

 is senior vice-president and general manager (IDMO Business), Cellares.

Despite the tremendous therapeutic prom­ise of cell and gene therapies (CGTs) for pa­tients globally, the space is at a crossroads. Long-standing issues around patient acces­sibility have contributed to investor pullback, biotech companies shuttering, and even a few life-saving therapies being pulled from markets.

The industry needs to do better to support all pa­tients in need. The biggest obstacle to accessibility has been pharma’s need to effectively reinvent manufacturing for living drugs made from human cells. It has not been possible to develop large-batch man­ufacturing as is done for most other therapeutic mo­dalities, meaning commercial-scale manufacturing has until now been unrealistic. Finally, the industry is beginning to incorporate Industry 4.0 concepts that have worked well for other types of manufac­turing, including automation.

Industry 4.0 is more than just the types of tech­nology that are deployed. Rather, these approaches underscore integration across the end-to-end patient journey. Many biopharmaceutical companies are still thinking about a black box (or several) to swap in for specific manufacturing processes, but that won’t enable the kind of scale most therapies will need to meet total patient demand. Still others are relying on contract development and manufacturing organiza­tions (CDMOs) to enable scale through next-generation end-to-end platforms, which can still be capacity constrained by upstream and downstream processes.

A new model is the integrated development and manufacturing organization (IDMO). As the name implies, this includes fully integrated smart manu­facturing facilities for true end-to-end scale. It relies on flexible manufacturing capabilities without re­quiring changes to hardware, meaning process modifications are entirely managed through software. As a result, technology transfer between smart facilities in any geography is streamlined through the lever­age of platform standards. Combined, these aspects will make it easier to scale cell therapies globally and meet total patient demand.

The tenets of the IDMO concept can be viewed from the top down: manufacturing facilities must be stan­dardized and interconnected, technology within each smart factory must ensure end-to-end integra­tion, and the platform technologies themselves must be robust enough to serve multiple functions.

Execution starts from the bottom up. From its be­ginnings, the biggest choke point in the cell therapy space has been manufacturing, which makes that the first place to start.

Today, commercial cell therapies have progressed toward becoming front-line treatments for certain hematological malignancies, meaning tens of thou­sands of additional patients may soon be eligible for these therapies. However, that number of batches haven’t even been manufactured yet in aggregate. It likely will not be long before cell therapies are also ap­proved in other indications, including autoimmune diseases. Even with heavy investment from pharma companies and the CDMO sector in new facilities and streamlined processes, traditional manufacturing is years away from meeting total patient demand.

Manufacturing at scale requires reducing the footprint, eliminating manual processes, increas­ing throughput, and lowering cost of goods. The most robust approach to address these issues is the deployment of fully closed and automated end-to-end manufacturing platforms. These platforms do not require traditional cleanroom spaces because manual process steps are eliminated through robotic orches­tration of streamlined and fully integrated manufac­turing processes.

“End-to-end” can be misleading. If a therapeutic de­veloper or CDMO has just purchased multiple units with the intent to scale, they will need to develop all new up­stream and downstream systems to match the system’s throughput. Even the best manufacturing system, in isolation, might just mask a bottleneck, rather than fix it.

The IDMO smart factory approach incorporates multiple ancillary technologies to enable the fullvalue proposition of end-to-end automated manu­facturing. That includes designed-for-purpose in­frastructure and facilities, requiring a high degree of engineering expertise.

John Tomtishen is senior vice-president and general manager (IDMO Business), Cellares.

When referring to this article, please cite it as Tomtishen, J. Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck. 

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

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

Israel Ortíz is vice president and general manager at Accruent.

Digital Transformation Strategies: Modernizing Business Processes, digital transformation strategies with an image of a digital roadmap for organizational change See Less | Image credit: ©Johannes – stock.adobe.com

Pharmaceutical manufacturers, such as Pfizer, Johnson & Johnson, and Novartis, are driving digital transformation to enhance production efficiency and maintain compliance—an essential factor in ensuring product quality, patient safety, and commercial success. However, navigating the evolving pharmaceutical regulatory landscape presents significant challenges, requiring substantial investments in both human and technological resources.

Digital Transformation in Pharmaceutical Manufacturing.

Striking a balance between compliance and innovation can introduce security concerns and operational complexities, particularly as manufacturers become increasingly data driven. As pharmaceutical manufacturers collect and analyze large volumes of sensitive data, such as production metrics and quality control records, ensuring the security and integrity of this information becomes critical. Part of this challenge is also the ability to track readily available, accurate data for presentation to regulatory boards. To address these hurdles, approved work procedures, visible audit trails, and environmental monitoring help prevent quality issues and product loss.

Robust computerized maintenance management systems (CMMS) software provides a centralized system for compliance, asset protection, and operational data. By leveraging such technology, pharmaceutical manufacturers can enhance efficiency, reduce costs, improve quality control, ensure accurate documentation, and strengthen cybersecurity and data integrity.

Navigating a complex regulatory landscape is one of the biggest challenges that pharmaceutical manufacturers face. Regulatory compliance not only safeguards patients and consumers, it also plays a pivotal role in maintaining trust within the industry. However, the constantly evolving nature of global regulations requires organizations to be both vigilant and adaptable, often necessitating substantial investments in human and technological resources.

Pharmaceutical manufacturers must adhere to strict guidelines set by regulatory bodies and codes, such as FDA, the European Medicines Agency (EMA), the US Code of Federal Regulations (CFR), and other international authorities. These regulations are designed to ensure drug safety, efficacy, and quality while maintaining transparency in production and distribution.

Key regulatory frameworks govern electronic records and signatures, requiring pharmaceutical companies to implement strict access controls, audit trails, and validation processes to ensure data integrity. They also provide guidance on computerized systems used in pharmaceutical manufacturing, emphasizing risk management, system validation, and data security. Enforced globally, good manufacturing practices (GMPs) ensure that pharmaceuticals are consistently produced and controlled according to quality standards. Compliance requires meticulous documentation, validated production processes, and stringent hygiene protocols. As regulations continue to evolve, manufacturers must proactively adopt digital tools to streamline compliance efforts. Failure to meet these regulatory requirements can result in costly penalties, production halts, and reputational damage.

In an era of digital transformation, data integrity has become a critical component of regulatory compliance. Regulatory bodies mandate that pharmaceutical manufacturers maintain complete, accurate, and tamper-proof records throughout the product lifecycle. This diligence ensures transparency and accountability in the production process, helping to prevent the loss of millions in products, as well as errors, contamination, or fraudulent activity.

Ultimately, while compliance challenges can be demanding, they also present opportunities for pharmaceutical manufacturers to modernize operations, enhance efficiency, and build greater trust with regulatory authorities. Compliance also presents opportunities—adhering to regulatory standards can drive operational efficiency, reduce costs, enhance quality control, and strengthen cybersecurity measures.

When referring to this article, please cite it as Ortiz, I. Digital Transformation in Pharmaceutical Manufacturing.