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

Felicity Thomas

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On the final day of CPHI Milan 2024, Oct. 10, 2024, a panel brought together by Fujifilm Diosynth Biotechnologies debated the numerous paths to “Building the Future Pharma Workforce” (1,2). Moderated by Pushpa Vijayaraghavan, healthcare practice lead at Sathguru Management Consultants, the other contributing panelists were Nagarjun Chakilam, director of Maithri Drugs; Jakub Knurek, business development specialist at Mabion; Morgan Rex, senior quality engineer at ApiJect; and Megan Smyth, senior team leader at Almac Group.

“There's two significant changes that I've really seen in my nine years of being in the industry so far,” Rex said. “The first is that there's a general trend, and this is really relevant in the United States, to bring healthcare out of the hospital in[to] the clinic and bring it directly to the patient as much as possible. And that trend is being driven by this desire to decrease the cost of healthcare while also increasing the access to healthcare, which will increase the adherence of patients to their medicine, which will improve vaccine accessibility—and so that's what we're seeing in the developed world, and … we're creating different formats for drug delivery and injections.”

Accelerating these changes in the industry have been some necessary adjustments in workflow and, in tandem, newly forged technologies resulting from the COVID-19 pandemic.

“So, the way it impacted us is, you know, [to] think about digitizing all the quality processes,” Chakilam said. In the past, quality processes were manual and siloed, according to Chakilam. “But now for us to embrace these new technologies, what we thought was it is more crucial and more important to digitize them first, and not just digitization like transforming from paper to screen or just doing something on the computer, but we want to have all those systems integrated in the back end as well.” Chakilam suggested technology trends be embraced and for the industry to move to implement flow chemistry once digitalization is completed. “Maybe at that point it will be a little bit more easier and more effective.”

“We're really excited about how we can unleash the power of AI [artificial intelligence] in our roles, in our organizations and our industry,” moderator Vijayaraghavan added. “How do we get our human capital, the security that there is still a people-driven future here? And how should people think of staying ahead of this curve and not feeling threatened by it, but, you know, being part of [the] revolution?”

Discussing the rise of women in leadership positions in the pharmaceutical industry, Vijayaraghavan made light of the expert panel consisting of more women than men, a point that was then elaborated on by Knurek.

“In every gender, [to] have that passion for biotech, for improvement that's really challengeable for all companies, how we can search, I think, more about headhunting, talent acquisition from that perspective?” he said.

In any case, Smyth said, the industry is expanding, and job recruitment is hearty. “There's just so many opportunities to be able to do so much in this industry. And you know, we've been building our capabilities towards manufacturing, and yeah, I think I'm really excited,” she said. “It's not going to be without its challenges, because we're doing a lot of these things for the first time, and it's exciting to be an innovator, but it's also going to have the challenges that need to be problem solved. And I think ultimately that's why most of us are in this industry, to be able to improve it and make it better.”

1. Vijayaraghavan, P.; Smyth, M.; Chakilam, N.; Rex, M.; and Knurek, J. Building the Future Pharma Workforce. Presentation at CPHI Milan 2024, Milan, Italy, Oct. 10, 2024.
2. CPHI Milan, Conference Agenda. cphi.com/europe/en/whats-on/agenda (accessed Oct. 10, 2024).

Articles

Five speakers discussed the impact of the COVID-19 pandemic, the rise of artificial intelligence, more women in leadership tracks in the industry, and various emerging technologies.

CPHI Milan 2024: What Does the Future Pharma Workforce Look Like?

CPHI Milan 2024: Evolution of Coating Design

 Europe spoke with Ali Rajabi-Siahboomi, vice president and chief innovation officer at Colorcon, about the evolution of coating design and how it has impacted investment, as well as innovations in packaging for oral solid dosage products.

Coating design for solid dosage products has evolved from sugar coating to film coating to solvent-based and then to aqueous coating over the years, according to Rajabi-Siahboomi. “But the development of this robust and optimized formulation that we've had, and the umbrella of the Opadry system, has made it much easier to have the right film coating, but at the same time, apply it much more efficiently,” he says. 

The functionalities of film coating have changed over the years as well, according to Rajabi-Siahboomi. “Many years ago, [film coating] was just more for adding color and recognizing different dosages and different product. Nowadays, we apply functionalities [such as] moisture barrier … putting tags in those film coating so that we can identify them as part of authentication and counterfeiting, anti-counterfeiting. So, there has been a whole evolution, but when we talk about some of these challenges, … it highlights the need for continuously focusing on innovating, bringing continuous improvement and innovation in this field.”

Click the above video to watch the full interview.

 is being held from Oct. 8–10, 2024 in Milan, Italy.

Ali Rajabi-Siahboomi is the vice-president and chief innovation officer at Colorcon, based at the Global Headquarters, USA. Rajabi-Siahboomi has held various academic positions in Nottingham and Liverpool JM Universities in the United Kingdom before joining Colorcon as technical director, responsible for Europe, the Middle East, and Africa, in 2000. His main research interests are solid dosage form pharmaceutics, pharmaceutical technology with emphasis on oral drug delivery systems, solubility enhancement to improve bioavailability, and consistency of drugs and bioequivalence formulations. He has published more than 300 articles, book chapters, abstracts, and patents and obtained his B.Pharm. and PhD in pharmacy from the University of Nottingham (UK).

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Pharmaceutical Technology Europe spoke with Ali Rajabi-Siahboomi, vice president and chief innovation officer at Colorcon, about the evolution of coating design and how it has impacted investment, as well as innovations in packaging for oral solid dosage products.

CPHI Milan 2024: Fill/Finish and Sustainability

Large-molecule therapeutic products are being increasingly developed that need to be administered via injection or infusion. As these products enter directly into the blood stream, they must be sterile and free of any potential contamination, which is increasing demand for fill/finish services.

The need for sterile dosage forms is a major change from what was required of manufacturers decades ago, when the key prioritization was on small-molecule drug products, notes Hanns-Christian Mahler, founder and board member of ten23 health. Another driver of growth within fill/finish includes the demand for glucagon-like peptide-1 (GLP-1) medicines, which are absorbing a large proportion of the manufacturing capacity, he adds.

However, regulatory guidance has also undergone revisions, which is having an impact on fill/finish facilities. “From my vantage point, I truly believe in isolator technology,” explains Mahler. “So, that’s where I think an isolator in cleanroom, Class C, is probably where you would want to go if you’re building new facilities. And I think a lot of struggles are ongoing with a lot of folks where, they're trying to actually make upgrades from a filling environment, and that obviously comes with a cost, with a shutdown, and with a potential risk.”

Additionally, regulatory bodies in Europe and around the world are putting greater emphasis on sustainability for facilities; although, Mahler believes there is a need for regulations to be stricter. “[Sustainability] has been a key question … and how we want to operate from a footprint perspective,” he says. In the new ten23 health facility in Visp, Switzerland, for example, the whole façade of the building has been covered in solar panels with photovoltaics, Mahler explains, allowing the company to produce enough energy it can provide the surplus back to the grid.

Hanns-Christian Mahler holds a PhD in Toxicology from the Institute of Pharmacy at the University of Mainz and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He previously worked for Lonza, Roche, and Merck, and currently serves on the boards of Bionter and KriyaBio. Hanns-Christian is also an editor for several pharmaceutical journals.

Pharmaceutical Technology® Europe sat down with Hanns-Christian Mahler from ten23 health to discuss the fill/finish market and sustainability considerations for facilities.

Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment in line with current regulatory requirements at CPHI Milan. 

CPHI Milan 2024: Evolution of Aseptic Processing Equipment for Regulatory Compliance

 sat down with Zaim Gashi, area sales manager, Steriline, to discuss current aseptic processing regulatory requirements and the evolution of aseptic processing equipment to stay compliant. Gashi, who joined Steriline in 2007, has held his current position since 2015. From 1992 to 2015, he built his expertise as a designer and developer of control systems, primarily within the pharmaceutical industry. This technical expertise provided a strong foundation for his current role, in which he manages agents and clients across Southeast Asia, West Balkans, Greece, and Bulgaria. 

Zaim Gashi, Area Sales Manager, Steriline. Image courtesy of Steriline.

“[A]septic processing equipment has evolved following generational technological and regulatory changes and [the] development of new drugs and consumables,” Gashi stated. Evolution of aseptic processing equipment has gone “from very simple equipment with almost an existing flexibility in the past, where the biggest responsibility was on the operators, [to] [t]oday, [where] we have the most sophisticated machines equipped with artificial intelligence technology, including robots with high flexibility,” he explained. Certain operational achievements that were once within the purview of manual operators are nowadays executed by robots or devices that are manufactured using high-precision components.

“In my opinion, the driving force is the ultimate goal of fulfilling the very strict rules imposed by current regulations. We must always bear in mind that we are mostly dealing with products that are injected into human or animal bodies. Therefore, it is of paramount importance to maintain septic conditions during the entire filling and finishing process. In this context, we cannot fail to mention Annex 1 of Volume 4 of the EU [European Union] guidelines, which has become something of a holy book for professional environmental monitoring. Reducing the risk of contamination caused by operators [is among] the important [considerations],” Gashi added.

Gashi also pointed out that, though the vast majority of Steriline’s customers choose isolators as their barrier system, isolators are not mandatory, according to Annex 1; however, isolators are mentioned almost 50 times. “Robotic systems are also mentioned, and [they] are likely to play the main role in environmental monitoring and gloveless isolators. The other driving forces are new drugs and consumables, especially single-use systems and RTU [ready-to-use] containers … [these] are mostly used in case of small batches,” Gashi said.

Attendees can visit Steriline at Booth A42 in Hall 18. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

CPHI Milan 2024: Growth and Challenges in the Sterile Injectables Market

 sat down with James Hamilton, president of Sharp Sterile, formerly Berkshire Sterile Manufacturing, which was acquired by Sharp in October 2023. Hamilton gave an overview of the sterile injectables market, the drivers for its growth, relevant hurdles that companies are facing, and how outsourcing service providers such as Sharp help those companies.

“On the product side, we're seeing tremendous innovation in biologics and complex molecules, and we all see this,” Hamilton said in the interview. “And the first place that those types of products tend to go are sterile injectables. So, I think the innovation in product discovery and clinical development is driving substantial uptake in sterile manufacturing. So that's kind of the big picture.”

Hamilton then went on to describe two distinct trends on either end of the industry spectrum.

“The first is that orphan drugs—personalized medicine, very small-batch manufacturing—[continue] to grow year on year. In fact, I think approaching 50% of drugs recognized by the FDA are in the orphan category. So there continues to be a significant growth in small-batch manufacturing. Conversely, we all hear about the GLP [good laboratory practice] ones and the explosion in this blockbuster category. So, you have sort of this dual set of circumstances driving small-batch manufacturing and sterile fill/finish at the same time that there's absolute growth and demand for high-capacity manufacturing. So, that's creating a very interesting dynamic in the industry.”

James Hamilton, president of Sharp Sterile, discussed innovation in products associated with sterile manufacturing and industry trends that are driving growth.

Stacey Treichler, senior director of global marketing and strategy, Purolite, an Ecolab company, spoke about current trends in the biopharma industry and innovations in purification resins at CPHI Milan.

CPHI Milan 2024: Exploring Current Trends and Purification Innovations 

 spoke with Stacey Treichler, senior director of global marketing and strategy for the Purolite resin business at Ecolab, during CPHI Milan about current trends in resin technology and purification in bioprocessing. According to Treichler, some of the trends in the industry are: increasing complexity of drug modalities, more biosimilars coming onto the market, and increasing focus on security of supply.

To give some examples on the trend in complex modalities, Treichler pointed out antibody-based therapies: “You might be talking about a bispecific or multi specific [antibody], or a really complex fusion protein. It's been really exciting to see the increasing complexity, because what that's doing is enabling drug development companies to address unmet need. And of course, that's what we're all striving to do—help address those unmet needs.”

However, the flip side of increasingly complex modalities is that these complex drugs can have much more complex challenges associated with manufacturing, Treichler noted. “Those developers can run into some issues when they're trying to develop a scalable, robust manufacturing process,” she said. For biosimilars, Treichler said that there is a large number of biosimilars coming into the pipeline and being launched onto the market. “Again, very exciting, because biosimilar developers are able to get those drugs to the market at a lower cost many times, which makes it more accessible to more patients. But a challenge that comes from that is trying to improve your manufacturing efficiencies and keep your costs down so that you can pass along those lower costs to the patient and, broader, in the industry,” she explained. “So, biosimilar developers are faced with that challenge of, how do I make my drugs more cost effectively?”

“Finally, security of supply and business continuity is top-of-mind coming out of the pandemic,” Treichler said. “I think what pharma developers have realized is you definitely cannot take your supply chain for granted. So, they're looking at, how can they dual source, or even triple source, critical materials into their manufacturing process? But they're also looking at, globally, where is the manufacturing happening, and what's my strategy in the global network to basically improve my business continuity? Businesses are definitely taking a more focused effort in that area.”

In terms of innovation in resin technology, Treichler said that there are few major areas of focus: complex complex modalities, binding sites, and improving cost of goods. “The manufacturing process can be harsh on [complex modalities]. When you treat those drugs with low pH, harsh chemicals, harsh conditions, they may aggregate, they may lose their folding, and they might not display the critical quality attributes that drug developers are looking for coming out of the manufacturing process,” she explained.

As for binding sites, Treichler pointed out that not every antibody has all of the typical components of a traditional antibody, so an affinity resin may be needed that binds somewhere else on the antibody to allow for purification. Meanwhile, improving cost of goods is prompting innovation in resin technology. Resins are also subject to harsh biomanufacturing conditions; low pH cleaning solutions, proteases, or other things coming out of the cell being purified and to which the resin is exposed can chew up the resin and impact its ability to bind. Some innovations being developed are trying to improve the durability of the resin so that they can go through more cycles, and, ultimately, drug developers can achieve productivity and reduce their cost of goods, according to Treichler.

Visit Ecolab at Booth 3D46 in Hall 3. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.