Aligning mRNA Progress with Regulatory Streamlining

BioPharm Peer Exchange

Dosage Forms: Roundtable on Oral Solid Dosage Trends

Drug Solutions Podcast: 

Pharmaceutical packaging must advance to adapt to new, complex modalities

Out-of-the-Box Packaging Advancements

From Theory to Reality: Automating Process Development

Drug Digest: 

The Importance of Appropriate Supplier Oversight

Ask the Expert

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

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.

Videos

Feliza Mirasol is the science editor for 

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.”

Click the above video to watch the full interview.

 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

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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.”

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

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.

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

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

3d printer with injector nozzle | Image Credit: ©phonlamaiphoto- stock.adobe.com

Advances in equipment and control systems for three-dimensional printing (3DP) are creating new opportunities to use this alternative manufacturing method for solid dosage drugs. Printers—which are available in good manufacturing practice (GMP) versions—use various additive manufacturing methods to build layer upon layer, which allows precise placement of multiple ingredients within a dose. This customization offers advantages for modified and controlled release, personalized medicine, and point-of-care manufacturing, such as in hospital pharmacies.

“3DP’s material placement turns geometry into a dosing parameter,” explains Sharon Flank, CEO of technology company InfraTrac. “It can use layer thickness, shape, and differential material properties to create complex versions of controlled-release particles.” For example, 3DP can create “upstairs and downstairs layers for a polypill of two or more APIs, or an outer layer and multiple inner layers for precision control of release. Shape manipulation can control release in a way no tablet will ever do,” Flank says. Although 3DP is not as fast as conventional tableting, it can be used to meet the needs of a smaller target patient population that was previously underserved. Custom modifications can be quickly performed via software that controls material placement, compared to conventional tableting that would require tooling changes, Flank explains.

Using 3DP, dosage shapes can go beyond tablets, Flank adds. InfraTrac is working with Stephen Hoag’s Applied Pharmaceutics Lab at the University of Maryland School of Pharmacy on extrusion-based 3DP techniques to create orodispersible films, such as a pediatric rifapentine dose to treat tuberculosis. Outside of oral dosage, the researchers are designing long-acting implants with internal compartments for subdoses.

One example of using 3DP to meet a patient need is Aprecia’s levetiracetam, a high-drug load, rapidly disintegrating design for patients with difficulty swallowing that was approved by FDA in 2015. Made using the company’s 3D-printed ZipDose technology, it was the first drug to be approved using 3DP. It is made with an open-bed, binder-jetting method. More recently, Aprecia has developed its Z-Form 3DP platform integrated with process analytical technology (PAT) that prints doses directly in their primary packaging. The company worked with Battelle to develop the new technology platform for the development and production of dosage forms with a range of functionalities, including the ability to 3D print customized tablets or those with multiple APIs (1).

Triastek is using its Melt Extrusion Deposition (MED) 3DP process for microstructured drug delivery platforms that it has designed for modified release, colon targeting, gastric retention, solubility enhancement, and for improving oral bioavailability of peptides. The company has five drug products in clinical development (in the United States, China, or both) that use these platforms, including its most recent, a 3D-printed drug product designed for extended release and absorption of drugs in the upper gastrointestinal tract that received investigational new drug (IND) clearance from FDA in early 2024 (2).

In July 2024, Triastek announced a collaboration with BioNTech to develop oral delivery forms of RNA therapeutics using 3DP. The researchers aim to use multilayer and multi-compartment tablet designs to minimize degradation in the gastrointestinal tract and deliver the dose to where it can be absorbed optimally (3).

In addition to serving smaller patient populations, the flexible, small volumes enabled by 3D printing are useful in formulation development and clinical manufacturing.

“In clinical and preclinical trial supply, a nimble, small-scale production system could save a lot of time and therefore money,” says Flank. “Whether the final doses are produced via 3DP or conventionally, it is clearly helpful to be able to test several different formulations in a single day or even hour.”

Triastek is working with Boehringer Ingelheim to quickly create multiple prototypes of a new chemical entity and examine dose designs and drug release behavior using its 3DP technology (4). The company says its formulation-by-design approach can accelerate early drug development.

Small 3D printers can be useful for point-of-care manufacturing in a hospital pharmacy or potentially for remote locations, such as battlefields or space travel. A GMP-ready printer from FABRX, the M3DIMAKER, is now available with either one or three printheads and with printhead attachments for different extrusion printing methods—fused deposition modeling, semi-solid extrusion, and direct powder extrusion (DPE).

“We are working with hospitals and healthcare providers to implement our 3D-printing solutions directly into clinical settings, allowing for on-site production of personalized medications,” says Alvaro Goyanes, director and co-founder of FABRX. The United Kingdom-based company also launched a US-based company, FABRX US, in 2024, and is working with InfraTrac and Hoag’s lab on PAT for quality control.

The researchers, funded by the National Institute of Standards and Technology (NIST) through a Small Business Innovation Research program, are working on a predictive model that uses a near infrared (NIR) spectrometer incorporated into the drug printer, in this case the FABRX M3DIMAKER2, says Flank. The lab initially used a Viavi MicroNIR spectrometer and is also testing a Sentronic instrument. “Preliminary results show how NIR can validate and even quantitate API, detect out-of-specification moisture, and reject certain mis-printed doses,” reports Flank. “A robust model should facilitate point-of-care customization by creating pass/fail quality parameters that allow the pharmacist to manage doses and flavorings while delivering GMP product.”

“Integrating PAT and advanced testing capabilities into our machines addresses a critical need for real-time quality control and assurance in 3D-printed pharmaceuticals,” adds Goyanes. “This integration ensures that every product meets stringent quality standards, enhancing the reliability and safety of the medications produced.”

Goyanes points out that the development of effective cleaning protocols for printheads is essential to maintain equipment performance and prevent cross-contamination. FABRX introduced a new DPE printhead cleaner in July 2024 to improve the cleaning process. The company continues to work on technologies to meet other user needs it has identified, including development of modular and scalable 3D printing systems that can be easily adapted to different production volumes and requirements, Goyanes says.

Another technology designed for 3D-printing of personalized medicine in compounding pharmacies is the Pharma Kit from CurifyLabs. The platform includes GMP-manufactured excipient bases (called Pharma Inks); a desktop-sized automated Pharma Printer; software containing a library of validated formulae of Pharma Inks with APIs that guides the user; and integrated, automated quality control tools.

“Our goal was to modernize and bring automation to compounding and hospital pharmacies to make safer products and save time,” says Niklas Sandler, founder and CTO at CurifyLabs.

The developers automated as much of the workflow as possible, including weighing, mixing, dispensing, and packaging, explains Sandler. The built-in quality control tools include NIR to test blend homogeneity and a weigh scale to measure every tablet. The library of premanufactured excipient bases that have been optimized for the printing process and the formulations that have been validated are crucial to the system, says Sandler.

“We did all the validation work up front so that it would be easy and quick for pharmacists to follow the validated process. The technology can be used to produce a wide range of dosage forms, such as tablets and suppositories, and to dispense liquids accurately. The Pharma Kit is used in several markets in Europe,” Sandler adds.

“Both Europe and North America are witnessing a growing adoption of 3D printing in the pharmaceutical industry,” Goyanes suggests. In 2023, Goyanes and others launched the Pharmaceutical 3D Printing Initiative, an international consortium to facilitate collaboration between academic institutions, healthcare providers, regulatory agencies, and industry players. Other partnerships with universities and hospitals aim to train the next generation of scientists and engineers in 3D printing technologies. “These collaborations are crucial for advancing the field and ensuring that our solutions are continually evolving to meet the dynamic needs of the healthcare industry,” Goyanes concludes.

Aprecia. Aprecia and Battelle Are Impacting the Pharmaceutical Industry Through 3D Printing Innovation. Press Release, Nov. 15, 2023.

Triastek. Triastek’s 3D Printed Gastric Retention Product T22 Receives FDA Clearance of IND Application. Press Release, Jan. 31, 2024.

Triastek. Triastek Announces Research Collaboration and Platform Technology License Agreement with BioNTech to Advance 3D Printed Oral RNA Therapeutics. Press Release, July 23, 2024.

Triastek. Triastek Announces Collaboration with Boehringer Ingelheim to Advance and Accelerate Research and Development of Innovative Pharmaceutical Products with MED 3D Printing Technology. Press Release, March 17, 2023.

Jennifer Markarian is a contributing editor to 


Vol. 48, No. 10
October 2024
Pages: 22–23

When referring to this article, please cite it as Markarian, J. Exploring 3D Printing for Solid Dosage Drugs. 

As a GMP manufacturing method, 3D printing offers benefits for modified release and personalized dosages. 

Exploring 3D Printing for Solid Dosage Drugs

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.

Datwyler, a provider of elastomer components, launched the NeoFlex Prefilled Syringe 10mL and NeoFlex Cartridge Wearable 10mL at CPHI Milan on Oct. 8, 2024. The new coated plungers are designed for large-volume injectables and are part of the company’s NeoFlex line, which includes the 0.5, 1, and 2.25 mL prefilled syringes, along with the 3 mL cartridge plungers.

According to the company, the desire for at-home care for chronic illnesses has increased the use of auto- and wearable injectors so that patients can self-administer treatments for conditions such as autoimmune diseases, neurological diseases, and cardiovascular diseases. These treatments are often large volume subcutaneous biopharmaceuticals (LVSCs), which are high-concentration and higher-viscosity formulas sensitive to impurities.

Use of auto- and wearable injectors is on the rise, driven by the embrace of at-home care for chronic diseases. These devices support the self-administered treatment of certain cancers as well as autoimmune, neurological, and cardiovascular diseases with LVSCs. Often, the injectables that must be administered are high-concentration, and higher-viscosity formulas that are sensitive to impurities. These drugs are expensive to manufacture and distribute, requiring the utmost attention to every component to uphold patient safety and prevent instances of contamination that can lead to recalls.

“If you’ve seen a loved one battle cancer, you know that time is precious—and so is the patient’s power to control how they spend it,” said Dirk Borghs, chief executive officer of Datwyler Healthcare Solutions, in a press release (1). “Auto- and wearable injectors stand to give millions of patients more power over their time in treatment. That represents a monumental shift in healthcare but it all rests on the quality and performance of these devices. Every component matters.”

The new additions to the NeoFlex line, like the current offerings, are covered in a non-fluorosurfactant grade fluoropolymer coating to prevent rubber particulates from shedding and to minimize degradation from extractables and leachables. “NeoFlex plungers are manufactured at Datwyler’s FirstLine facilities to ensure highest level of quality assurance and risk mitigation with cleanroom environments, automated production cells, and 100% camera inspection,” the company stated in the press release.

Because the plungers are naturally lubricious, silicone is unnecessary for smooth operation inside the syringe or cartridge barrels, and compatibility with complex formulations is supported, which offers effective delivery of a highly sensitive, highly viscous biologic.

Highly viscous products require certain processing techniques, such as pump choice, to minimize costs and ensure quality. “Datwyler worked closely with leading pharmaceutical companies and system integrators to design the new NeoFlex plungers for superior machinability when filling larger cartridges with minimal headspace and controlled plunger compression. This collaboration is essential to support effective commercialization,” the company stated.

Datwyler can be found at Booth 20B48 at CPHI Worldwide in Milan, Italy, which is being held from Oct. 8-10, 2024.

1. Datwyler. Datwyler Launches NeoFlex Plungers for Large Volume Biologics in Auto- and Wearable Injectors. Press Release. Oct. 8, 2024.

The company has expanded its NeoFlex coated plungers with new sizes for large-volume auto-injectors and wearable devices. 

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