Latest Conference

CPHI Milan 2024: Improving Efficiency and Reducing Costs for Oral Solid Dosage Forms

 caught up with Michelle Logan, vice president of the drug product division at Thermo Fisher Scientific, at CPHI Milan to discuss the oral solid dosage (OSD) forms market, its key trends and challenges, the affordability of these drugs within the market, and how OSD developers and manufacturers can drive those costs down and improve efficiencies in their processes at the same time.

“We are really focused around expanding capability and the early development side of things, so we can start earlier on with our customers and transition them through successfully all the way to commercialization,” Logan said in the interview. “So, you'll see that as some of our main offerings and focus, as we continue to expand and support capacity in this space.”

Logan said the digital space is an area Thermo Fisher has identified as wanting to increasingly use to its advantage.

“I think when you think about our commercial capacity that we have, the more we can leverage digital to drive initiatives improvements like line functionality, the better it is for our customers,” she said. “At the end of the day, that's really around the automation side of things ... our oral solid dose customers are leveraging routinely with us to help save from a cost perspective.”

Click the above video to watch the full interview.

Visit Thermo Fisher Scientific at Booth 7B18. 

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

Videos

Michelle Logan, vice president of the drug product division for Thermo Fisher Scientific, talked about expanding capability to better serve customers in the OSD market.

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.”

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).

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.

Camille Dumont, PhD, manager, customer applications, Lonza, discussed current industry trends that are having an impact on development work in oral solid dose formulations.

CPHI Milan 2024: Industry Trends Impacting Oral Solid Dose Formulation

At CPHI Milan, Camille Dumont, PhD, manager, customer applications for Innovaform Accelerator at the Capsules & Health Ingredients business of Lonza, spoke with 

about bio/pharmaceutical industry trends and their influence on oral solid dose formulations. 

Camille Dumont, Manager, Customer Applications, Lonza. Image courtesy of Lonza.

“One of the trends we see with our customers, with the rise of inflamed bowel disease occurrence, is the oral delivery of live biotherapeutic products, which are originally administered for very invasive techniques,” she said. “[N]ow, we see lots of people working to have [these products] administered as a solid oral dosage form. Another important trend is the oral delivery of biologics such as peptides, proteins, mAbs [monoclonal antibodies], or mRNA [messenger RNA]. Most of these drug modalities are currently injected.”

Dumont pointed out that the injection route of administration can reduce patient adherence and can have a significant cost on healthcare systems. She emphasized that these types of APIs are fragile, however, and so require innovative solutions to achieve significant oral bioavailability. “Most of the time, only a combination of various strategies will result in [achieving] significant bioavailability and efficacy of these drug modalities, such as [using] enabling formulation devices and so on.

We offer formulation and targeted release capsule innovation to support this kind of need,” she stated.

To increase the bioavailability of many of these new drugs and new chemical entities, Dumont observed that there is a need for enabling formulation strategies, including permeation enhancers. “Recently, we have seen that a lot of biotechs [are] work[ing] on smart devices that are able to deliver fragile drug modalities directly by injection into the wall of the gastrointestinal tract. We can see that most of these innovations … rely on target release of the formulation … Solutions for target deliveries such as functional capsules appear as really interesting solutions for the pharmaceutical industry,” Dumont said.

With Lonza for about three years, Dumont is a chemical engineer with a PhD in pharmaceutical sciences from the University of Lyon, France. She has 10 years of experience in the pharma industry in developing innovative solutions for bioavailability enhancement, with particular expertise in lipid-based formulation and oral bioavailability enhancement of small and large molecules.

Attendees can visit Lonza at Booth 6A2. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

CPHI Milan 2024: The Role of Excipients in Pharmaceuticals

 sat down with Vinod Tuliani, Head of Pharmaceutical Sciences at Roquette, to talk about new developments in the use of excipients in dosage forms and methods of delivery. Tuliani discusses how the industry is working on new delivery forms for biologics and how this impacts excipient producers.

Regarding methods of delivery, Tuliani points to oral delivery as a focus for Roquette. “The biggest area really for us is in oral delivery, simply because there's a measure of convenience with oral delivery. People would rather take a tablet or a capsule rather than, you know, have to take an injection, which is, I think, common across the world. So clearly, we are very active in the area of oral delivery.”

New delivery methods for biologics are important for both patients and manufacturers, says Tuliani. “I think it's a huge plus for customers and patients, if they're able to obtain some of these medications through a route that's not injectable; certainly, people who have to take repeated injections would much prefer an oral delivery mechanism. We have been working on oral delivery systems for proteins and peptides, and we have been making good progress in that area, using conventional formulations, but delivered in a new way,” says Tuliani. “There's a lot of excitement in the field of delivery of proteins and peptides through alternate means.”

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

Pharmaceutical Technology® Europe sat down with Vinod Tuliani, Head of Pharmaceutical Sciences at Roquette, to talk about new developments in the use of excipients in dosage forms and methods of delivery. 

TOP NEWS on grunge world map | Image Credit: © Sean K - stock.adobe.com

CPHI announced the winners of the 2024 Pharma Awards on Oct. 8, 2024 at CPHI Milan in Milan, Italy (1). And the winners are:

Future Leader Award: Megan Smyth, Almac Sciences

Woman of the Year Award: Julia Tsetis, OFET Pharmaceutical Group

CEO of the Year: Guy Clark, CNX Therapeutics

API Development and Innovation: Lonza, AI-Enabled Route Scouting Service

Drug Delivery and Device Innovation: Adare Pharma Solutions

Finished Formulation: Unistraw, UniLayer Straw Delivery System

Manufacturing Excellence: RheaVita, RheaLyo GMP-Flex continuous freeze-dryer

Packaging and Machinery: Smurfit WestRock, CereScreen Digital Display Label

Regulatory and Compliance: ProPharma Group, Prodigy

Start-Up Initiative: Acu-Flo Ltd, Nebu-Flow nebulizer platform

Sustainability Award: Evonik Industries AG, PhytoSquene

Heart of Pharma Award: West Pharmaceutical Services

Accelerating Innovation Award: AustinPx, KinetiSol Technology.

The new Future Leader category was awarded to Megan Smyth of Almac Sciences for rising through five levels in her seven years at the company and for being awarded a UK Research and Innovation (UKRI) Future Leaders Fellowship. “Megan has built an innovative flow chemistry platform at Almac and there is a clear strategic alignment between her career intentions and the future requirement for leadership within the company,” CPHI stated in the press release.

The other new category, Woman of the Year, went to Julia Tsetis, CEO of OFET Pharmaceutical Group, for her commitment to innovation, sustainability, and social responsibility. “In her role as CEO of the OFET Pharmaceutical Group she is regarded as a true visionary and trailblazer in the pharmaceutical industry and has left an indelible mark on the global healthcare landscape,” the press release stated.

Guy Clark, CEO of CNX Therapeutics, was awarded CEO of the Year for significantly growing the company and transitioning it to a standalone entity with £50 million in revenues with more than 20 products sold worldwide.

The API Development and Innovation category went to Lonza for its AI-Enabled Route Scouting Service, which uses artificial intelligence (AI)-enabled predictive tools “that combine theoretical retrosynthesis with supply chain intelligence to identify commercially viable routes. This crystallizes the company’s advanced, data-driven approach to retrosynthetic analysis for designing optimal synthesis routes for small molecule APIs.”

Adare Pharma Solutions won the Drug Delivery and Device Innovation category for its tremors and other uncontrolled body treatments. “Based on an innovative sprinkle formulation, it is a game-changer for patients who struggle to take capsules due to hand tremors or difficulty in swallowing as it can be easily mixed into soft foods or liquids,” CPHI stated.

The Finished Formulation award was given to Unistraw’s UniLayer Straw Delivery System 2mg Loperamide HCl straw, which delivers medication via a plant-sourced and fully compostable polymer straw. This sustainable solution enhances compliance and reduces misuse.

The RheaLyo GMP-Flex continuous freeze-dryer +1 2 from RheaVita was given the award in the Manufacturing Excellence category. It is the first continuous freeze-drying system for aseptic good manufacturing practice production.

CereScreen Digital Display Label from Smurfit WestRock received the Packaging and Machinery award for its seamless integration of digital screens into clinical trial investigational medicinal product packaging. “The screen allows for multiple pages and contains all required label content, including QR codes and other information. In addition, the labels can be customized to suit the specific needs of the trial, including support for multiple languages,” CPHI stated.

The Regulatory and Compliance category was given to Prodigy from ProPharma Group. The suite of AI and advanced automation applications solve productivity challenges that can cause delays and incur costs. “It effectively removes delays, de-risks program delivery, shortens time-to-insight and enhances the overall medicinal value of its clients’ assets,” the press release stated.

Acu-Flow Ltd’s Nebu-Flow nebulizer platform received the Start-Up Initiative Award for overcoming technical limitations by “generating a soft aerosol, with high inhalable fraction (>90%), which can aerosolize biological formulation, such as RNA.”

The Supply Chain Excellence category was awarded to QYOBO GmbH for “a platform that provides crucial insights into global supply chains to help companies identify, manage, and anticipate supply risks. With data from over 250 sources, QYOBO offers a comprehensive view of supply chains for over two million drugs in over 40 countries, enabling quick, informed actions to mitigate risks and prevent drug shortages.”

Evonik Industries AG received the Sustainability Award for their PhytoSquene plant-based squalene for parenteral applications. “This is the first plant-derived, GMP-quality squalene. Pharmaceutical-grade squalene is currently sourced from shark liver oil, which depletes shark populations and negatively impacts marine biodiversity, whereas PhytoSquene is made from amaranth oil from the herbaceous plant 

, which can be grown as a renewable feedstock in many regions of the world.”

The Heart of Pharma award went to West Pharmaceutical Services for its collaboration with the Fox Chase Cancer Center, a National Cancer Institute (NCI)-designated Comprehensive Cancer Center, in the delivery of cancer screenings to residents of Pennsylvania via a mobile screening unit. 

AustinPx received the Accelerating Innovation Award for its KinetiSol Technology, which is a fusion-based, solvent-free process designed to address poor drug solubility. “As new molecules emerge with complex properties, traditional formulation methods struggle to meet the demand for effective drug absorption. KinetiSol disrupts the status quo by rapidly converting crystalline drugs into amorphous solid dispersions, significantly enhancing bioavailability.”

“CPHI continues to drive the future of pharma by creating a platform where innovation thrives, and the brightest minds can exchange ideas and form impactful partnerships that elevate the entire pharmaceutical industry,” said Tara Dougal, Brand and Content Director at Informa Markets, in the press release. “I am thrilled to congratulate the winners of 2024 CPHI Pharma Awards, with special recognition to those honored in our new categories, the Future Leader Award and Start-up Initiative Award. These trailblazers are not just advancing drug discovery and delivery but inspiring the next wave of innovation and leadership in pharma. A heartfelt thank you to everyone who participated and to our esteemed jury, whose insights have helped spotlight the very best our industry has to offer.”

1. CPHI. CPHI Excellence in Pharma Award Winners 2024. Press Release. Oct. 8, 2024.
2. CPHI. Awards—CPHI Milan. 

cphi.com/en/europe/cphi-celebration/awards.html

Articles

The winners of this year’s awards showcase achievements in pharma excellence.

Winners of CPHI Excellence in Pharma Awards Announced

The 2024 CPHI Annual Report, a survey of more than 280 pharmaceutical industry executives from more than 40 countries, is forecasting an increase in biotech capital and fast-paced growth of outsourcing in 2025, according to a press release on Oct. 7, 2024 (1).

The outlook is especially rosy, CPHI said, for larger contract development and manufacturing organizations (CDMOs)—or those with certain assets or specialized technologies such as peptides and radiopharmaceuticals—that are based in the United States (1). The report found that biotech companies in Europe have so far had a strong year in 2024, to the extent that US investors are increasingly looking across the Atlantic, particularly at the United Kingdom, for sources of innovation.

“Overall cash runways are improving, alongside favorable economic conditions and interest rate cuts,” said report expert Brian Scanlan of Edgewater Capital, as quoted in the press release (1). “This, in turn, should prompt biotechs to return to more traditional spending patterns, with CRO [contract research organization]/CDMOs benefiting from increased confidence in the financial outlook over the next 12 months.”

Naturally, the release of the report coincides with the start of CPHI Milan 2024, ongoing from October 8 through 10.

“We are witnessing a record-breaking event this week, with unprecedented levels of partnering across the industry,” CPHI Milan Brand and Content Director Tara Dougal said in the release. “European biotech hubs are expanding rapidly and securing crucial funding, and CPHI Milan will play a key role in helping these groups connect with the right partners to advance their projects.”

Scanlan and Irena Maragkou of Global Data, Bikash Chatterjee of Pharmatech Associates, and Gil Roth of the Pharma & Biopharma Outsourcing Association participated in an expert panel on the first day of the conference, moderated by Dan Stanton of Informa Connect Life Sciences, discussing key findings from the report (1).

Despite the areas of strength the report identified, there are some challenges to growth being felt by other types of companies, namely smaller CDMOs and early-stage biotech companies (1). Also, after peaking in 2022 and 2023, the venture market in China is now in a decline phase according to the report, trending downward toward pre-pandemic levels from 2019.

CPHI Milan expects some 600 CDMOs to have representation on hand over the three-day event. But on a larger scale, many companies are competing for funding; the press release indicated that more than 6000 companies worldwide have R&D pipelines at the moment, but more than 50% of these only have one or two products in development, making them less attractive in the current competitive climate.

“The partnerships formed over the next three days will be crucial for the sector's growth in 2025,” Dougal said. “Across the show floor, we’re witnessing rising confidence levels, and the long-term outlook for the industry is incredibly strong.”

The full CPHI Annual Report for 2024 is available for download on the CPHI website 

–Part 4: Biotech Capital on the Rise and Outsourcing to Accelerate in 2025–But Uneven Growth for CDMOs. Press Release. Oct. 7, 2024.
2. CPHI. 

European biotechs have had a strong year in 2024, causing those in the United States to increasingly look to them for innovation.

CPHI Research Forecasts Growth for Biotech, Pharma Markets in 2025

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.

Results from the 2024 CPHI Annual Report suggest that contract manufacturing organizations (CMOs) and hybrid companies—companies having both their own pipelines and contract services for using spare capacity—will hold over half of global biologics capacity within the next three years. The results predict a dramatic shift from current (2024) global totals.

In 2024, total global biologics capacity is allocated as follows: nearly 60% controlled in-house, 28% held by CMOs, and 15% held by hybrid companies, according to the annual report. The report predicts that CMO capacity, which is rising fast, will account for 40% of total global biologics capacity by 2028, 45% of which will be located in Asia. The results suggest that capacity for new clinical products entering development may not be easily accessible in the United States, despite capacity being available. Europe and Asia combined are expected to account for approximately three-quarters of all available CMO resources in 2028, according to the report.

“Our Bioproduction Zone at CPHI Milan mirrors these findings. We are seeing a rapid increase in the numbers of bio CDMOs [contract development and manufacturing organizations] at our event, and we expect this be one of the fastest areas of growth in the next few years,” said Tara Dougal, Brand & Content director—Pharma, Informa, in a press release. “Particularly notable [in the report] is the rising capacity in Asia and among newer CDMOs.Many attendees visit specifically to start building their networks with these new partners.”

Over the past two decades, overall biologics capacity rapidly expanded from nearly 600 kL in 2000 to just above 6700 kL today; capacity is projected to grow to nearly 9000 kL by 2028, according to analysis provided by Dawn Ecker, managing director of bioTRAK Database Services at BDO. Insight from this analysis shows that, for the first time, CMOs will hold four of the top five capacities in 2028. Ranked in order from largest-to-smallest capacity holder, these CMOs are: Lonza, Samsung Biologics, FujiFilm Diosynth Biotechnologies, and WuXiBiologics. These four CMOs are estimated to control 34% of capacity between them. By 2028, CMOs will account for nearly 60% of global biologics capacity within the top 10 capacity holders, according to the annual report.

“The era of CMO production dominance is clearly arriving and is much needed, with many smaller companies now developing new biologics—especially mAbs [monoclonal antibodies]. This is significant for CPHI, where we see many more biotechs and early stage companies now attending to find suitable capacity—particularly for small production runs where they are more likely to partner with one of the hundreds of smaller CDMO partners. Helping find these ‘perfect fits’ is vital, and CPHI Milan is integral as a platform for meeting many different vendors, customers, and bioprocessing firms in one convenient location,” Dougalsaid in the press release.

CPHI Milan, held Oct. 8–10, 2024 in Milan, Italy, will host a panel on “Global Trends in Bio-Manufacturing” in addition to a number of important bio sessions and seminars as well as insights on “Optimizing Biologics Production with Single-Use Technologies” and lowering production costs with “cell line development” and “continuous bioprocessing”, according to the press release.

The full CPHI Annual Report will be released at CPHI Milan and will be made available for download at 

According to the annual survey, four of the five biggest biologics capacity holders in 2028 will comprise CMOs, which are expected to have 45% of all CMO capacity in Asia.

Latest Conference Articles