Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey

The Alliance for mRNA Medicines (AMM) officially launched in Berlin, Germany during the 11th International mRNA Health Conference held Oct. 31–Nov. 2, 2023. Two of the three conference organizers, BioNTech and CureVac, are AMM members already, while Moderna is taking a wait-and-see attitude toward the new scientific society. Pfizer, Sanofi, and AstraZeneca are also on the sidelines, while more than 30 other organizations have already become founding members like BioNTech and CureVac. Becoming a founder member gives these organizations a seat on the board of AMM.

Regulators in the United States, especially, but also in Europe, Asia, and Oceania, have open robust dialogue about the possibilities of using the special case of messenger RNA (mRNA) platform technology to potentially work from the same single set of guidelines, monographs, standards, and shared core principles. The broader life science community has also discussed standardizing critical quality attributes (CQAs), chemistry, manufacturing, and controls (CMC), process development procedures, and commercial best practices.

As AMM represents a new avenue in medicines, there is also speculation about sharing pre-competitive resources. During the Berlin mRNA Health Conference, it was posited that, given mRNA’s potential to address unmet needs in oncology, a large-scale project centered around a possible “antibody atlas” was introduced in backroom conversations.

Andy Geall, the founding chairman of the AMM board of directors said, “There needs to be a coordinated effort now to educate the public about what’s coming. Because this is coming at a speed they are not used to. This isn’t traditional pharmaceutical development. This is coming at light speed with such an array of different approaches and technologies that we need to get out in front to educate the public, governments, and regulators—to put things in place that demystifies this for them.”

“As scientists we can do that,” Geall continued, “We are going to begin with vaccine misinformation and try and demystify the technology. More importantly, lets’ start educating people about the breadth of what’s coming. We’ve got people working in rare diseases, gene editing is happening, gene therapy, vaccines in both infectious disease and oncology. So, there’s a lot of misinformation that’s going to be out there. Let’s get out ahead of it as scientists, as a community with one voice, and start to teach people about what’s coming.”

More than 30 organizations became founding members in Berlin, including 

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The Alliance for mRNA Medicines (AMM) was officially launched at the 11th International mRNA Health Conference in Berlin, Germany.

Alliance for mRNA Medicines Officially Launched in Germany

Poorly aqueous soluble compounds account for a major proportion of the drug development pipeline and, if not correctly formulated, can end in costly failure for companies. To overcome the obstacle of poor aqueous solubility in drug development, companies can choose from a number of different approaches, such as particle size reduction, salt formation, using a surfactant, and so on.

University of Copenhagen spin-out company, Zerion Pharma, has developed a new technology, Dispersome, to help solve drug solubility issues. To learn more about the company and its new formulation platform, 

 spoke with the company’s chief executive officer, Ole Wiborg, at CPHI Barcelona 2023.

“We have developed a new technology platform that can be used to [increase the] solubility of small-molecule drugs,” specified Wiborg. “Generally, our technology works for most small-molecule drugs, even for some of the molecules that are characterized as ‘brick dust’—which means almost like sand and so you cannot make them into solution.”

Additionally, Wiborg revealed that the technology is finding use within the cannabis field—an area where there are some very difficult molecules to work with. “So, in general, I would say that [our technology] is applicable across a broad area … and works for up to 80% to 90% of molecules,” he stated.

Experimental work on the company’s platform has also been published in peer-reviewed journals, Wiborg pointed out. For example, in June 2023, Zerion Pharma announced that work from two partnership projects had been published in both the 

International Journal of Pharmaceuticals 

, which demonstrated the relationship between drug loading and dissolution of Dispersome formulations of Nimodipine (1).

“We are now anticipated at the beginning of next year [2024] we will have two clinical studies with our partners that are in the cannabis field,” Wiborg remarked. “So, we will soon have a lot of human data to support the technology.”

1. Zerion Pharma. Zerion Pharma’s Dispersome Technology Published in Two Peer-Reviewed Papers Through Partnerships with Pharmaceutical Companies. 

Zerion Pharma was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

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Pharmaceutical Technology Europe® spoke with Ole Wiborg from Zerion Pharma, a Danish pharmaceutical development company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Increasing Solubility with Zerion Pharma at CPHI Barcelona

Demand for intranasal drug delivery methods has been spurred on by various factors, such as the rising prevalence of allergic rhinitis cases and asthma. As a convenient, non-invasive, alternative route of administration, continued growth in the sector has been forecasted by market researchers (1).

Dr. Ferrer BioPharma—a Florida, US-based company that was founded in 2020—is focused on innovation in the field of intranasal medicines through the use of nanoparticle technology. During CPHI Barcelona 2023, 

 spoke with Dr. Ferrer BioPharma’s CEO, Gustavo Ferrer, to learn more.

“Dr. Ferrer BioPharma is a company that was originated by a group of clinicians/doctors and the whole idea was to look into how we can improve the medications that are delivered into the upper airways—the nose and the respiratory system,” Ferrer specified.

Over a decade ago, Ferrer explained that he and his colleagues started looking into specific things that were bothering patients and clinicians around treatment. Collating the information that was gathered into a book, it became apparent that with over-the-counter medicines that were being consumed, neither the patient nor clinician fully understood what they were using, Ferrer continued.

Using the collected data, it was then possible to start working on optimized medications and associated delivery systems, Ferrer stated. “And, [we are] looking into ways of integrating the delivery service more as well,” he said.

The inaugural Start-Up Market at CPHI Barcelona 2023 has been a great success, according to Ferrar. “[The market] gave us access to presenting our information on our data, discussing with big companies, big tech companies that are looking into new innovations that are coming to CPHI,” he asserted.

Next year’s start-up area should be even more well attended in Ferrar’s opinion. “This is the first time that CPHI has done this [start-up area], and I think it has been highly successful,” he said. “I think, next year, in Milan, you’re going to see a lot more [start-ups].”

In the future, Ferrar noted that Dr. Ferrar BioPharma will continue to optimize drug delivery, providing solutions for medicines to be available with less side effect, so, the pathway to the consumer is shorter. “Our goal in the next few years is to get into the European market,” he revealed.

Nasal Drug Delivery Technology Market Report 2023–2033.

Dr. Ferrer BioPharma was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Gustavo Ferrer from Dr. Ferrer BioPharma, a US company focused on innovative intranasal medications, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Improving Intranasal Treatments with Dr. Ferrer BioPharma at CPHI Barcelona

Throughout many industries, continuous manufacturing has proven to be advantageous when compared with traditional batch processing, providing a faster, cheaper, and more flexible option. Within the pharmaceutical industry, there has been some adoption of continuous manufacturing processes; however, a fully end-to-end continuous pharmaceutical process is still challenging (1).

For CONTINUUS Pharmaceuticals—a spin out company from a multi-year collaboration between MIT and Novartis—producing drugs effectively and at a lower cost has been the primary mission. To learn more about the company and how it is enabling end-to-end continuous manufacturing, 

 spoke with the company’s senior marketing manager, Leonardo Vincenzi, at CPHI Barcelona 2023.

"We specialize in process development,” explained Vincenzi. “We have developed, over the years, a plethora of enabling technologies to allow the continuous manufacturing of pharmaceuticals.”

Generally dealing with large pharmaceutical companies, Vincenzi pointed out that CONTINUUS Pharmaceuticals provides process development technology that allows their customers to convert their batch manufacturing systems into continuous ones.

Recently, CONTINUUS Pharmaceuticals has worked with the United States government in response to the COVID-19 pandemic and to aid in the manufacture of some of the drugs that were in shortage, Vincenzi revealed.

“One of the class of drugs that were challenging for us and pushed us to develop new technologies were high-potency products and controlled substances,” Vincenzi said. “Therefore, we developed new technology and new labs for us to work on these kinds of products.”

For Vincenzi, the key differentiating factor for CONTINUUS Pharmaceuticals is the fact that they are offering an end-to-end solution, something that he hasn’t seen anywhere else. “We go from the raw material to your preferred drug product, all the way through your reaction, filtration, drying steps to the final tableting or vial filling,” he remarked.

1. Domokos, A.; Nagy, B; Szilágyi, B.; Marosi, G.; Nagy, Z.K. Integrated Continuous Pharmaceutical Technologies—A Review. 

CONTINUUS Pharmaceuticals was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Leonardo Vincenzi from CONTINUUS Pharmaceuticals, a US company that specializes in process development, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Converting to Continuous Manufacturing with CONTINUUS Pharmaceuticals at CPHI Barcelona

Visual inspection is an integral process in the production of filled and sealed pharmaceutical products to ensure there are no particles or contaminants in the finished parenteral dosage form. Currently, both manual and automated processes are used for visual inspection; however, automated systems can be expensive to implement and not always accessible for smaller companies dealing with smaller batch sizes.

Accessibility of automated visual inspection solutions is a key focus for Luo Automation, a Dutch company researching, developing, and producing automated visual inspection machines. To learn more about the company and how it is making visual inspection more accessible, 

 spoke with the company’s founder, Joren van der Horst, at CPHI Barcelona 2023.

"We make visual inspection [solutions] for very small batches,” explained Horst. As with all visual inspection technologies, the primary aim is to check the quality of the medicine and make sure there are no foreign particles or contaminants present, he added.

To perform the inspection, the finished dosage form—syringes, ampoules, and vials—are swirled and then any movement of particles within can be detected, Horst continued. “Another cool thing is the [current interest] in artificial intelligence and machine learning,” he said. “We use machine learning algorithms that are pretty new to also detect static defects. So, not only particles but also leakages and such.”

For Horst, a major differentiator for Luo Automation within industry is the focus on smaller-scale inspection. “If you want, you can buy a huge inspection machine that will cost you a couple of million, but then you need to produce 100 million containers per year,” he stressed. “But, if you have clinical trials or personalized medicine, you cannot [perform the inspection] with a huge machine.”

Luo Automation was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Making Visual Inspection Accessible with Luo Automation at CPHI Barcelona

Within the highly regulated pharma industry, adoption of new technologies is generally slower than in other industries, as such, despite three-dimensional (3D) printing being available for some time now, its use in the production of medicines is still very much a novelty. However, 3D printing technology has a great potential within the pharma industry, particularly for personalized medicines.

FABRX, a small start-up company that was created by academics from the University College London in the United Kingdom, is focused on the use of 3D technologies in the future of medicine. At CPHI Barcelona 2023, 

 spoke with Carlos Rial Calvo, lead software engineer of FABRX AI—a subsidiary of FABRX based in Spain and started in 2023—to learn more.

“Our aim is to personalize medicine for patients,” explained Rial Calvo. “This is very useful, for example, for highly potent drugs that require very specific dosing.” Additionally, using 3D printing technology to personalize medicine is very useful for pediatrics, who can find swallowing medication difficult, so, Rial Calvo pointed out that it is possible to produce medication that is easier for children to adhere to.

Similarly, for patients that need to take multiple tablets, Rial Calvo noted that with the 3D technology it is possible to create polypills—a combination of different APIs in one printlet (3D printed tablet). “We create polypills, and then [the] patient only has to take one tablet,” he said.

FABRX is currently collaborating with hospitals across Europe, Rial Calvo specified. “For example, we are running a clinical trial in an [oncology] hospital in France to combine an anti-cancer drug with a drug for the side effects [of the cancer treatment] into the same pill,” he stated (1).

In another clinical study, the company has worked with the University of Santiago de Compostela and the University Hospital in Santiago de Compostela in Spain to develop a 3D printed medicine for a rare disease, Rial Calvo revealed. For this study, FABRX prepared doses of isoleucine for children with maple syrup urine disease—an inherited metabolic disorder (2). Using the 3D printing technology, flexible production of a personalized dosage form was possible.

“We provide the software for controlling the machines, but also the software provides features to help with the development of new formulations,” Rial Calvo concluded. “So, the researchers can use our software as well, with the machine, to test new materials.”

1. FABRX. FabRx and Gustave Roussy Enter into an Agreement to Develop a Novel, Personalised, Multi-Drug Dosage Form for the Treatment of Patients with Early-Stage Breast Cancer. 

, Press Release, June 25, 2021.
2. FABRX. FabRx Performs the First Clinical Study Using Personalised 3D Printed Dosage Forms to Treat Children with a Rare Metabolic Disease. 

Fabrx was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Carlos Rial Calvo from FABRX, a pharmaceutical 3D printing company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.