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Feliza Mirasol

Nicolas Camper, senior director—Bioconjugation Chemistry, Abzena, discussed new advancements in ADC technologies, including the role of complex chemistries.

CPHI Milan 2024: New Developments in ADC Technologies

*Editor's note: updated on March 3, 2025 to fix typographical error.

spoke with Nicolas Camper, senior director—Bioconjugation Chemistry at Abzena during CPHI Milan. Camper discussed the advancements in conjugation and linker technologies in antibody-drug conjugate (ADC) development and manufacturing. 

Nicolas Camper, Senior Director—Bioconjugation Chemistry, Abzena. Image courtesy of Abzena.

“There have been a lot of new developments in terms of conjugation and linker technologies. There is a definitive move towards site-specific conjugation technologies and away from stochastic conjugation approaches that allows [us] to prepare better-defined antibody-[drug] conjugates,” Camper said.

Another new development that has been observed over the past few years is that linkers are becoming more sophisticated. “Quite often, when you conjugate cytotoxic drugs, they are quite hydrophobic, and that can impact the performance of your ADC. So, there has been a lot of effort put into developing more hydrophilic linkers,” he noted.

Finally, another noticeable advancement in this area has been the development of branch linkers. Branch linkers give some options to prepare ADCs and modulate the drug loading, Camper explained. “[T]hat is something relatively new and should have an impact on the performance of ADCs and ultimately result in better ADCs and more programs,” he stated.

In his role at Abzena, Camper has scientific oversight of the group’s R&D activities focusing on ADC design and developability for external clients. His responsibilities involve technical management of pre-clinical ADC development projects from discovery stage to lead candidate selection. The group has expertise in synthetic chemistry, assembling linker-payloads, conjugation of the linker-payload to various types of protein carriers (primarily antibodies), and analysis of these bioconjugates.

Attendees can visit Abzena at Booth 18H11. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

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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.

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 

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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.

CMOs and Hybrid Companies Predicted to Hold 54% of Biologics Capacity in 2028, According to CPHI Annual Survey

Andrew Lewis, PhD, Chief Scientific Officer, Quotient Sciences, discussed the CMC challenges with GLP-1 and oral peptides during CPHI Milan.

CPHI Milan 2024: Navigating CMC Challenges for GLP-1 and Oral Peptides

During CPHI Milan, Andrew Lewis, PhD, chief scientific officer at Quotient Sciences, sat with 

 to discuss the chemistry, manufacturing, and control (CMC) challenges encountered during the development of glucagon-like peptide 1 (GLP-1) and oral peptides.

Lewis noted that a poor correlation seems to exist between the performance of oral peptides in preclinical animal studies and humans. “So, the approach we've pioneered at Quotient is to really tightly integrate our drug product manufacturing and clinical testing … by tightly integrating them, not only does it mean that we can rapidly advance [oral peptide products] into the clinic, but it also enables us, through the use of adaptive CMC clinical strategies, to modify formulations in response to emerging clinical data,” he stated.

Lewis also said that GLP-1s present tolerability challenges, and that this is true of this class of drugs as a whole. Permeability challenges can be addressed by the use of permeation-enhancing technology combined with modified release formulations, which may also enhance control of the pharmacokinetic profile and, hopefully, manage adverse events. “I think it's probably worth pointing out as well that, for oral peptides, they are particularly [used] with permeation enhancers. They are specific. They're very different formulations [from] a standard tablet formulation. You typically will require quite large amounts of permeation enhancers, so they make up a significant percentage of the formulation,” he explained. “Many of these permeation enhancers are quite waxy, [while] some of them are [somewhat] semi-solids.” These characteristics make permeation enhancers generally poorly compressible. In addition, they exhibit poor flow, which can make tableting or granulation difficult.

“There [are] certainly specific formulation and manufacturing processability challenges with oral peptides,” Lewis said. “Peptides behave very differently to small molecular weight drugs.”

You can visit Quotient Sciences at Booth A90 in Hall 7. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

Sweden-based biotech company, Cellevate, which specializes in developing next-generation cell culture systems, announced on Oct. 3, 2024 that it is ready to pre-launch its nanofiber microcarriers for viral vector manufacturing in gene therapy production at CPHI Milan, occurring Oct. 8–10, 2024 in Milan, Italy. According to a company press release, these nanofiber microcarriers are the first to be available on the world market.

The nanofiber microcarriers, marketed as Cellevat3d, are designed to provide up to 60 times more surface area for cell growth than conventional systems, increasing yield and productivity in upstream bioprocessing of gene therapy applications. The microcarriers are engineered for stirred-tank bioreactors and support a wide range of upstream bioprocessing applications in addition to gene therapy, including pluripotent stem cell (PSC) expansion, organoid formation, human embryo kidney (HEK)-based recombinant proteins, and HEK-based vaccine production.

“Scalable, sustainable, and single use, Cellevat3d nanofiber microcarriers closely mimic the human extracellular environment, providing higher cell densities and enhancing yield for viral vector production compared to current standard microcarriers based processes,” said Laura Chirica, PhD, CEO, Cellevate, in the press release.

The company will make Cellevat3d nanofiber microcarriers available for pre-order at CPHI Milan. The product’s official commercial launch is slated for the upcoming BIO-Europe in Stockholm, Sweden, on Nov. 4–6, 2024.

“Our nanofiber microcarriers effectively address the key challenges of low productivity and high manufacturing costs facing the industry. With this pre-launch of Cellevat3d nanofiber microcarriers starter pack at CPHI Milan, we’re excited to provide early access to a completely new category of cell culture systems currently unavailable on the market. Cellevat3d nanofiber-based cell culture systems truly have the potential to transform biomanufacturing for advanced therapies and take a significant step toward making these therapies more accessible to patients,” Chirica said in the press release.

The Cellevat3d technology is a green and sustainable technology innovation, according to the company. The platform allows for industrial-scale production of nanofiber microcarriers—with significantly enhanced surface area for cell growth, reproducibility, customization, and scalability. The company expects these advantages will ultimately lead to an improved biomanufacturing productivity and process economy.

Safety concerns over virus-based vectors are driving investigative attention toward nanotechnology-based non-viral vectors. However, challenges around low transfection rates with nanotech-based non-viral vectors and their poor tissue-targeting ability need to be addressed. Current research suggests that nanocarriers such as non-viral vectors may have a critical role in enhancing gene therapy delivery, especially in the field of pulmonary disease therapy (1). In addition, other non-viral nanocarriers are being investigated as drug delivery systems, including organic-based nanoparticles—such as cellulose, collagen, silk-like polymers, elastin-like protein, silk-elastin-like protein—and inorganic-based nanoparticles (2).

1. Wang, H.; Qin, L.; Zhang, X.; Guan, J.; Mao, S. Mechanisms and Challenges of Nanocarriers as Non-Viral Vectors of Therapeutic Genes for Enhanced Pulmonary Delivery. 

, 970–993. DOI: 10.1016/j.jconrel.2022.10.061
2. Hajebi, S.; Yousefiasl, S.; Rahimmanesh, I.; et al. Genetically Engineered Viral Vectors and Organic-Based Non-Viral Nanocarriers for Drug Delivery Applications. 

 (20), 2201583. DOI: 10.1002/adhm.202201583

The nanofiber microcarriers are the first of their kind for manufacturing viral vectors used in gene therapy production, according to Cellevate.

Cellevate Plans Pre-Launch of First Nanofiber Microcarriers for Viral Vector Manufacturing at CPHI Milan

On Oct. 1, 2024, SGD Pharma, a global provider of pharmaceutical glass packaging solutions, announced that it plans to exhibit an innovative range of products and services at CPHI Milan in Milan, Italy, from Oct. 8–10. As part of its exhibition, the company will introduce its siliconized molded glass vials. The company’s siliconization process is an internal treatment that provides additional functionalities to a glass vial, according to a company press release.

The internal silicon coating provides protection for sensitive, aggressive, and viscous drug products. In doing so, the coating reduces interactionwiththepackagingandpreservesdrugproductintegrity, according to the press release. SGD stated in the release that siliconizationisavailable for all glass types and for vials ranging in size from 3 mL to 500 mL, both clear and amber glass. The siliconization processissuited toallroutesofadministration, including parenteral,oral, andnasal administration.

“SGDPharma’s €5 million [US$5.5 million] investment in the siliconization production line at its state-of-the-art Saint-Quentin Lamotte(SQLM)plant [in France]enablescustomerstoreceiveordersofhigh-performancevialsatspeed meeting global demand,” the company stated in its press release.

The growing demand for the approval of biologics as well as new therapeutic approaches and the development of specialty drugs is driving the need for ready-to-use (RTU) packaging, SGD Pharma said in its press release. The company offers a RTU solution in molded glass, which includes its Sterinity EZ-fillvials (aregisteredtrademarkofStevanatoGroupand/oritsaffiliatesinoneormorejurisdictions). The Sterinity EZ-fillvials are designed for the rigorous requirements demanded by the pharmaceutical industry. The increased quality and flexibility of these vials enable the shortening of time-to-market and reduce total cost of ownership, according to the press release. Sterinity is suitable for various applications in veterinary and human health.

“AtCPHI2024,weareshowcasingsolutions developedwithourpharmaandveterinarycustomers’needsinmind,aimedatenablingthem tobringtheirdrugstomarketquicklyandsafely.Thiscommitmenttoinnovationisreflectedby our dedication to sustainability, which is an integral component of our company strategy. As we support theUNGlobalCompact forthefifthconsecutiveyear, we are particularlyproudof our progress in reducing carbon emissions at our global glass manufacturing sites,” said OlivierRousseau,CEO,SGDPharma,in the release. “SGD Pharma’s renewable energy initiatives, including the upgrade of our furnace at Saint Quentin Lamotte (SQLM) in France and the installation of solar panels at our Vemula, India, plant, underscore an overarching focus on decarbonization with the company-wide goal to cut emissions recorded in 2020, by 35% by 2030, and by 65% by 2040. These efforts reflect our responsibility to our customers, partners and the planet as we strive for a safer and healthier environment.”

The company will present an extension to its Sterinity range at CPHI, including the debut of aRTUTypeIImoldedglassvial. Sterinity RTU in Type II is expected to initially be available in size 10H, and an extendedrangeofsizes is expectedto launch during2025. SterinityTypeIiscurrently available in sizes 10 mL, 20 mL, 25 mL, 50 mL, and 100 mL. Type I is available in both clear and amber glass.

In addition, SGD Pharma will present an extension to its IDENCY range that includes 20 mL and 6 mL sizes. The company will also introduce new caps for its Ensiemo syrup bottles. The presentation will include the following:

IDENCY, a Type I glass vial that combines the benefits of both molded and tubular technologies, for parenteral sensitive drugs.

Ensiemofull packaging solution, apharma-grade TypeIII glass vialand pipette, which is now available with polypropylene or polyethylene caps for a tamper evident and child resistant closure.

The company now offers LabServices, an analytical testing service in molded glass for its customersandpartners (1). Through this service, experts at SGD Pharma’s SQLM plant provide analytical testing for pharma and biopharma companies, contract manufacturing organization and contract development and manufacturing organizations, and other glass manufacturers. The company expects to launch more LabServices in 2025.

The showcase will be held at SGD Pharma’s booth, 20B11, during CPHI.

1. SGD Pharma. New Labservices for Pharmaceutical Molded and Tubular Glass, Available Exclusively to SGD Pharma Customers and Partners. 

As part of a range of sustainable products and services that SGD Pharma plans to showcase at CPHI Milan, the company will introduce its siliconized molded glass vials.