Milan is a city in perfect balance. As both the strategic financial center of Italy and the fashion and design capital of the world, it offers just the right mix of practicality and opulence. The city provided the perfect backdrop for the world’s largest pharma event, giving the industry the opportunity to flaunt its own duality.
Celebrating its 35th anniversary, CPHI — which took place October 8-10 in Milan, Italy — was larger than ever, spanning 24 halls and hosting 59,000 attendees and over 2,800 exhibitors.
The CPHI show floor was buzzing with business dealings, but at the same time, the industry’s ability to trendset was on full display, as companies produced an array of flashy new products and services, showcasing flexibility, innovativeness and most notably, a responsiveness to patient needs.
Shifting with Patient Perceptions
It may sound trite at this point, but COVID changed things. One of these shifts, which was evident at CPHI, has come in the form of evolving consumer/patient perceptions about health.
Faced with overloaded health care systems and short supplies of medication during the pandemic, many patients, whether out of necessity or desire, began taking more active roles in their own health. And this, in turn, has affected how the pharma industry, and its suppliers, make decisions.
“The safety and effectiveness of drug ingredients used to be solely framed around regulations. But now you have another variable — consumer perceptions,” said Colorcon CEO Simon Tasker.
According to Tasker, Colorcon is seeing its customers (pharma and nutra manufacturers) shift from treatments and cures to more preventative products. And as patients/consumers ask more questions about the drugs and supplements they take, suppliers like Colorcon need to set up their customers to be able to answer these inquiries.
“We translate features to benefits for our customers, so they can then educate their customers,” said Tasker.
Consumer perceptions tend to vary by geography. On the nutraceutical side, Coloron has seen this firsthand when it comes to the herbs used in traditional Chinese medicine. According to Tasker, when selling to the U.S. market, these ingredients require flavor and odor masking, as they generally don’t start out with an appealing taste or smell. But in China, masking the smell/taste of traditional herbs is met with skepticism. The example goes to highlight the growing need for both manufacturers and suppliers to be responsive to a variety of individual market perceptions.
Formulation Innovation
The focus on patient needs and preferences was also evident on the drug delivery side, with numerous new innovations showcased on the tradeshow floor.
CDMO Adare Pharma Solutions has a track record of delivering innovative patient-centric oral dosing solutions — and this reputation was further solidified when Adare returned home from Milan with a CPHI Award in the Drug Delivery and Device Innovation category.
Adare took the gold for its sprinkle formulation, developed using the company’s proprietary MMTS Minitabs technology, designed for patients who struggle to take capsules due to hand tremors or difficulty in swallowing. The new formulation consists of oral granules that can be easily sprinkled over soft food or mixed into a liquid, providing a flexible and convenient administration method.
Adare accomplished this through a novel method that increases the compression folds of the minitablets to make sure they can withstand the hardening process of the sprinkle’s taste-masking coating. The company hopes to use this same technique for future microencapsulation projects, setting the stage for further innovation.
Another patient-inspired shift evident on the show floor was based on the widely recognized truth that most people hate getting shots. “Our customers have patients they know will never get injections,” said Meeta Kratz, global VP of strategic growth and revenue management for Lonza’s Capsules & Health Ingredients business.
Kratz, together with colleague Camille Dumont, Ph.D., delivered a compelling presentation about capsule innovation, with a focus on accelerating oral drug delivery. Dumont serves as the manager of customer applications for Lonza’s newly launched Innovaform Accelerator. The France-based facility, opened in September, will serve as a center of excellence for developing and innovating capsule-based manufacturing and delivery solutions for oral and pulmonary administration.
The oral delivery of biologics, specifically peptides, was a frequently discussed topic at CPHI. Lonza currently has over a dozen partnerships with pharma companies focused on oral peptide formulation. “Peptides can be quite fragile, so you need formulation ‘tricks’ to deliver them orally,” said Dumont.
Lonza’s proprietary Capsugel Enprotect bi-layer capsules are designed to protect acid-sensitive APIs, prevent gastric irritation and allow for intestinal delivery. The bi-layer manufacturing technology allows targeted delivery of APIs to the small intestine without the need for additional coating excipients, which accelerates the drug manufacturing and development processes.
Integrated CRO and CDMO Quotient Sciences is also seeing a big interest from clients in the systemic delivery of oral peptides.
The most acclaimed example of an oral peptide is a project that Quotient Sciences worked on —Novo Nordisk’s Rybelsus, a tablet version of the GLP-1 semaglutide, approved in 2019. “Rybelsus showed us that oral delivery of peptides is not only technically feasible but acceptable to regulatory agencies,” said Andy Lewis, chief scientific officer for Quotient Sciences.
Novo’s semaglutide tablet utilizes a permeation enhancer — a chemical compound incorporated into its formulation — a popular method used to improve oral peptide bioavailability. Specifically, Rybelsus relies on salcaprozate sodium (SNAC) to enhance the absorption of semaglutide in the stomach and protect it from degradation by gastric enzymes.
When developing oral peptides, Quotient Sciences’ clients can adjust formulation compositions, evaluating multiple permeation enhancers within a clinical study. This is made possible through the company’s proprietary Translational Pharmaceutics platform, which increases flexibility within the drug development process, facilitating real-time decision- making based on emerging clinical data
Quotient has found that this method can shorten development times by more than 12 months.
While there is certainly a business case behind the race to get oral peptides to market, there are also advantages for patients. The current demand for GLP-1 drugs has caused an industry-wide scramble for fill-finish capacity, ultimately contributing to drug shortages. OSD capacity, on the other hand, is widely available — meaning tablets and capsules can likely get to consumers faster than injectables.
“Oral peptides are considered the holy grail of pharma, but fundamentally, it comes down to patient needs,” said Lewis.
The Rise of Nutra
The newest kid on the pharma block made its presence known at CPHI, as there was noticeable convergence of pharma and nutraceuticals on the show floor.
As post-COVID consumers continue to prioritize wellness and health, they are doing so discerningly. According to Sara Lesina, general manager (EU and Americas) of dietary supplement CDMO Sirio, consumers are taking a more ‘natural’ approach to preventative health, favoring dietary supplements that use plant-based ingredients and probiotics. To meet that demand, Sirio showcased two new innovations at CPHI — a GummiBiotics range powered by branded, science-backed macrobiotic strains and HeartClear omega
3 softgels, which are intrinsically enteric, uncoated and carrageenan-free, so consumers can take their omega 3s without the fishy after-burp.
According to Lesina, Sirio works with reputable, science- backed partners, making sure that the ingredients the company sources are supported by clinical studies. Earlier this year, Sirio announced that it had partnered with Cargill to create a postbiotic gummy, featuring Cargill’s EpiCor, a postbiotic whole food yeast fermentate, an ingredient clinically shown to support immune health.
This pharma-level accountability extends to internal processes as well at Sirio. “Sirio has its roots in pharma and our QA/QC processes still mimic that of the pharma industry,” said Lesina. In addition, 13% of Sirio employees are devoted to R&D.
Just recently, Sirio spent $17.4 million to build a dedicated packaging facility, complete with automated packaging lines, at its Pritzwalk campus near Berlin. The facility is designed to ensure the seamless transfer of pharmaceutical and nutraceutical softgels from the adjacent manufacturing site, all operating under a unified pharmaceutical GMP standards regimen.
Colorcon’s Tasker echoed a similar sentiment, emphasizing the growing value of translating pharma capabilities into the nutra space. With the nutraceutical regulatory environment moving towards stricter oversight of product safety and health claims, companies that prioritize regulatory compliance and quality assurance are better positioned to build trust.
Ultimately, CPHI attendees left Milan with ample evidence that patient-centricity has gone from trend to staple for both the pharma and nutra industries.
Publication Details
This article appeared in Tablets and Capsules Magazine:
Vol. 22, No. 5
November/December 2024
Pages: 15-17