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

Felicity Thomas

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.

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

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.

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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.”

Click the above video to watch the full interview.

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.

CPHI Milan 2024: Compliance and Automation in Aseptic Processing

It has been a little over a year since the European Union’s Annex 1 revisions came into force (1), meaning that companies manufacturing sterile medicinal products should be compliant with the new version of the regulatory guidance. However, the road to compliance for any regulatory change is often fraught with challenges, and for Annex 1, Klaus Ullherr, senior product manager at Syntegon, highlights two in particular that he has encountered as a machine builder.

The first challenge to overcome is that of maintaining clean air, so, ensuring that the air flowing down from above onto the machine does not come into contact with anything prior to reaching the product, Ullherr notes. “The second [challenge],” he continues, “is the aseptic setup, meaning that you now have to have autoclave parts.”

A key aspect helping to overcome challenges and ensure compliance is employing more automated solutions in the aseptic processing line. Automation also reduces human intervention, which is critical as humans pose a huge threat to product quality through potential contamination, Ullherr asserts.

Furthermore, automated systems allow for processes to be performed completely reproducibly, Ullherr continues. “We know from presentations from FDA that many deviations within pharma are caused by human error,” he summarizes. “The automation of processes really gives us the opportunity to reduce these deviations significantly.”

Annex 1 Manufacture of Sterile Medicinal Products

Visit Syntegon at Booth 18C33. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

Klaus Ullherr, senior product manager, Syntegon

Klaus Ullherr is a senior product manager at Syntegon with a University degree in electrical engineering. Before joining Syntegon in March 2000, he worked as a project manager in the electrical industry for several years. At Syntegon, his main responsibilities include global product responsibility, market analysis, and initiating new product developments. He is a member of the PDA and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a well-known speaker and trainer covering trends and solutions for fill/finish equipment.

Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.

CPHI Milan 2024: Trends in Oral Solid Dosage Forms

 sat down with Uwe Hanenberg, Head of Product Implementation at Recipharm, to talk about key trends shaping the oral solid dosage market, including technology advances and industry investments.

Hanenberg sees the oral solid dosage market growing, in part by the aging population, as well as a trend toward reducing the number of suppliers and the creation of strategic partnerships. Oral biologics are a popular development in the industry, because of the easy method of administration, as well as the push for continuous manufacturing processes, according to Hanenberg.

Investment will continue in the oral solid dosage market, according to Hanenberg, pointing out the popularity of glucagon-like peptide-1 (GLP-1) diabetes and weight loss drugs. “There will come further big products. And that is certainly not to be executed on an existing tablet line or blister line,” says Hanenberg. “That is something where you need more investment … I expect to see announcement on investment in high-potent capabilities, especially in CDMO [the contract development and manufacturing organization] space, anything that is related to completion of offerings to reach an integrated solution, which means I expect a further consolidation of the CDMO market. Then I expect a very significant investment in continuous manufacturing. There are big companies who have a commitment to produce, in future, 50–80% of all new launches on continuous manufacturing.”

Uwe Hanenberg, Head of Product Implementation, Oral Solid Dose


Dr. Uwe Hanenberg is Head of Product Implementation, Oral Solid Dose (OSD) at Recipharm. Uwe is responsible for implementing and executing the OSD Product Development strategy that assures science driven, timely development of new products or services. Uwe has 25 years of experience in the pharmaceutical industry with Bayer, Altana, Grünenthal and Catalent. He has held several leading positions in quality, manufacturing and packaging, product development, project management within the Science & Technology sphere. His areas of expertise are oral formulation development, oral manufacturing technologies, stick pack technologies and pharmaceutical contract services and project management.

Pharmaceutical Technology Europe sat down with Uwe Hanenberg, Head of Product Implementation at Recipharm, to talk about key trends shaping the oral solid dosage market, including technology advances and industry investments. 

Felicity Thomas

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