Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

Industry Outlook 2025: Through the Lens of a Service Provider

At the macro level, and through the lens of a service provider to R&D, there are three key trends that have impacted the bio/pharma industry over the course of 2024, according to Adam Sherlock, CEO of Qinecsa Solutions, a pharmacovigilance technology and services solution provider. “The three key things that I've seen this year are really an increased pressure on price and an increased scrutiny of the cost of health and the cost of health care provision globally; then we've had the kind of mega trend of AI [artificial intelligence]; then the third piece is actually, from a therapeutic point of view, has been the unbelievable success of the GLP-1 [glucagon-like peptide] class of products, and the potential implication for a much broader range of conditions, diseases, and treatment areas using GLP,” he says.

When looking at AI and the technology agenda for the industry in more detail, Sherlock believes there are two key areas that will be impacted. “The first is, what can AI/machine learning/robotic process automation/digitization do for efficiency and productivity? So, we see that as a service provider, we're looking to use these technologies to be more productive and more efficient, faster, and higher quality in terms of what we do for our clients, but we're also baking that into our own technology solutions that we are then selling to clients, and clients are using within their own businesses. So, the efficiency agenda, and that, of course, drives towards not just better productivity, but also, you know, lower cost. That's one key major theme that technology is enabling,” he says. “Then the other is, in the truest sense of AI, what innovative, new, generative output can be created by the industry using AI, whether that's around truly novel therapies, the use of data to find different patient cohorts, etc.?”

Adam Sherlock is CEO of Qinecsa Solutions, which is a UK-headquartered, international pharmacovigilance technology and services solution provider. Adam has more than 35 years’ experience within the pharma services industry and has held senior roles in a number of different pharma services businesses over the past 15 years.

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Pharmaceutical Technology® spoke with Adam Sherlock, CEO of Qinecsa, about the industry trends of 2024, the future technology agenda, and M&A prospects in 2025.

Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging

In this episode of Ask the Expert, Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection. A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences.

“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.

Click the video above to watch Dr. Margosch answer the following question:

“My company recently had critical incidental findings in several vials during secondary packaging. What can be done to minimize the risk of future market batches containing defective units?”

Dr. Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging, Vetter Pharma-Fertigung GmbH & Co KG

Dr. Dirk Margosch is Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter, a global CDMO specializing in aseptic filling and packaging of injection systems. Margosch holds a degree in food science. He joined Vetter more than 15 year ago and has held various positions in the field of visual inspection and packaging.

Dr. Margosch joined the pharmaceutical service provider Vetter Pharma-Fertigung GmbH & Co KG in 2008 as head of production overseeing process implementation, product-specific qualification and operation of automated visual inspection systems, until he was given the opportunity to manage the entire visual inspection department including both, manual and automated visual inspection. Since 2021, he has been responsible for non-aseptic production, which encompasses automated and manual visual inspection, assembly, and secondary packaging.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

Pharmaceutical Technology chats about the increasing prevalence of challenging APIs in the development pipeline and the hurdles facing formulators and manufacturers as a result of this trend with Jens Schmidt from Lonza.

Dealing with Challenging APIs

Chronic illnesses and an aging global population are increasing the demand for innovative pharmaceutical products to help alleviate symptoms, prevent illness, or even provide a cure. As a result, pharmaceutical companies are investigating more complex and challenging APIs to seek out the most effective treatments for patients; however, these ingredients pose a number of development hurdles.

According to Jens Schmidt, associate director MSAT at Lonza, there are a few factors driving the trend of increasingly complex and challenging APIs entering the development pipeline. One clear driver has been the industry’s improved understanding of biological pathways, which has led to the investigation of more intricate molecular structures to target such pathways, he explains. Additionally, the desire to achieve very high selectivity while minimizing side effects, the use of multi-target drugs, and overcoming pathogen resistance are also contributing to the rising prevalence of more complex molecules being developed, Schmidt adds.

When formulating more challenging APIs, more advanced techniques and specialized solutions are required to overcome issues such as poor solubility and bioavailability, Schmidt continues. “There can be pure manufacturing challenges like flow properties. [which] are typically not so great compared to standard or smaller molecules,” he says. “So, process development is getting even more important. It's important for a smaller molecule as well, but it's more even more important for the larger molecule [drugs].”

Jens Schmidt is the Associate Director of Manufacturing, Science, and Technology (MSAT) at Lonza.

Jens Schmidt is the Associate Director of Manufacturing, Science, and Technology (MSAT) at Lonza. In this role, he leads a team of MSAT scientists and serves as the technology lead for high-throughput experimentation focused on small molecules.
Before joining Lonza in 2017, Jens gained valuable experience as a research associate at the University of Oxford and the California Institute of Technology (Caltech). He is an organic chemist by training and holds a Master of Science in Chemistry from the University of Leipzig and a PhD from the University of Hamburg.

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

Using Continuous Processes and Automation to Remove Contamination Risk

Continuous production has been employed across many industries for some time to improve efficiencies, reproducibility, and quality. For the bio/pharma industry, continuous processes have come a long way, although semi-continuous is still more widely adopted.

“I think, of late, [continuous processing has] come a long way,” asserts Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology. “We're still seeing there aren’t that many full continuous processes out there, but we do see a lot more semi-continuous processing. So that's where you're sort of combining two or maybe three processes together, and that that may be to start with, in terms of stacking them up, allowing the continuous process of material going from one process into another.”

Additionally, with the advent of more robotics, particularly in a cleanroom space, there is scope for companies to remove the operator from certain aspects of the process, which is helping to reduce risk, Dunne confirms. “Placing a robot into the process stream removes the operator, and that's the best thing you can do, from a containment perspective,” he says. “You have less risk for the operator, but you also have a vast improvement on the product quality as well. We do know from a microbiological perspective that generally it's the operator which is the most contaminating source on the process. So, if you can get [the operator] out of there, you've improved both the containment from the operator perspective, and also the product quality as well.”

Automation and reducing potential contamination are common threads throughout the European Union good manufacturing practice (GMP) Annex 1 guidance document, Dunne notes. “It's kind of a theme that's running through the whole of that document, isolating the operators from the process,” he says. “We're seeing lines now that are almost completely autonomous. And I think that [more automation is] going to be something that's going to come in the not-too-distant future.”

Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology.

Christian Dunne is director of Global Corporate Business Development at ChargePoint Technology—a pharmaceutical containment and aseptic processing specialist company. Christian has worked in the bio/pharma industry for 20 years covering oral solid dosage manufacturing through to sterile processing and fill/finish manufacturing.

In an interview with Pharmaceutical Technology Roger Viney from ICE Pharma highlights the importance of sustainability for the bio/pharma industry and some important future considerations for companies.

Creating a Sustainable Approach

Sustainability in the pharmaceutical industry has increased in the past few years as a significant initiative for regulators and many pharmaceutical companies. Sustainability practices may include investment in renewables, zero emission buildings, and greener manufacturing practices (1). ICE Pharma has adopted a sustainability strategy that includes fighting illness through product innovation, caring for people, accelerating sustainable operations, and building strong relationships (2).To gain more perspective on sustainability in pharma, 

spoke withRoger Viney from ICE Pharma about what pharmaceutical companies should consider when developing a sustainability strategy.

Viney stresses that the healthcare industry, which is responsible for approximately 5% of global emissions, must be aware of the impact the industry has on the environment. “I think it's important to recognize that what we manufacture is biologically active,” says Viney. “So, in that case, it has a bigger environmental impact than some other products. I think in terms of the regulations that we have to comply with, you know, or the quality compliance regulations, I think the pharma industry is relatively slow to change, and we're slow to introduce new manufacturing technologies. We have difficulty adapting to new technologies which would lower our environmental impact. So, I think we've been slower than we would have liked. It's the nature of our industry. But I think, of course, there's a very big expectation from our customers, whether it be governments, businesses, or patients, that we do make progress in this area.”

Sustainability in the Pharmaceutical Industry

 (accessed Dec. 16, 2024). 
2. Lavery, P. 

ICE Pharma Touts Fully Recyclable Booth at Its CPHI Milan Exhibit

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

Pharmaceutical Technology chats with Roger Viney from ICE Pharma about bile acids in detail, including how they are useful in helping to improve drug solubility and absorption.

Improving Solubility and Bioavailability with Bile Acids

Poor solubility and bioavailability are becoming increasingly problematic for drug developers as more complex molecules are entering the development pipeline. “Bile acids are nature’s surfactants, their primary role is to promote the absorption of fat-soluble nutrients,” says Roger Viney, PhD, chief commercial officer for ICE Pharma—a bile acid expert. “So, depending on the bile acid, you can vary the hydrophilic lipophilic balance [and] improve bioavailability of poorly soluble drugs.”

“Furthermore, the bile acids can play a role as enhancer of permeability,” Viney continues. “[Bile acids are] able to modulate the cell membranes to allow certain drugs to cross the biological barriers more effectively. So, we have examples today, existing examples of oral and injectable applications formulations that use bile acids as excipients, and we are expecting to see this expand into things like transdermal and even nasal applications.”

Bile acids have been used in traditional forms of medicine for thousands of years; however, they did not enter modern and Western medicines until the 1960s, Viney notes. “The past 20 years have seen a very significant amount of research done into bile acids and their recognition that they're more than nature's surfactants, that they're, in fact, signaling molecules that have metabolic function,” he adds. “And so, this kind of research has opened up a whole new field where bile acids can potentially treat oncology, liver diseases, even neurodegenerative diseases.”

Felicity Thomas

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