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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.

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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. 

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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.”

 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

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.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

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. 

Datwyler Launches NeoFlex Plungers at CPHI Milan 2024

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Thermo Fisher Scientific is launching Accelerator Drug Development, described as the company’s 360° contract development and manufacturing organization and contract research organization drug development solutions, as part of its showcase at CPHI Milan 2024, happening in Milan, Italy from Oct. 8–10, 2024. Thermo Fisher announced its exhibiting schedule in a press release on Oct. 7, 2024 (1).

According to the company, Accelerator Drug Development will impact the pharmaceutical value chain for biotech and large pharmaceutical companies with its customizable manufacturing, clinical research, and clinical supply chain services for small molecule, biologics, and cell and gene therapies (1). The services are intended to assist customers at every stage of the drug development lifecycle.

“Thermo Fisher is transforming drug development and manufacturing processes to support customers as they move critical programs forward to tackle global health challenges with speed, quality and efficiency,” said Michael Shafer, executive vice president and president, biopharma services, Thermo Fisher Scientific, in the press release. “We connect the steps between discovery and delivery—from early testing and analytical support to clinical research design to trial conduct, clinical supply chain management, manufacturing and commercial scale-up—and we strive to ensure a seamless transition, mitigate risks, and accelerate innovation at every stage.”

The launch of Accelerator Drug Development comes on the heels of a busy summer 2024 for Thermo Fisher, which in June opened a new building at its good manufacturing practice (GMP) facility in Middleton, Wis., then announced the completion of its acquisition of Olink Holding, a Sweden-based provider of next-generation proteomics solutions, in July (2–3). The company has also expanded sites in Cincinnati, Ohio, and Bend, Ore., to enhance R&D, manufacturing, and testing capabilities for oral solid dose drug formulations (1).

Thermo Fisher can be found at Booth 7B18 at CPHI Milan. Sessions at which its experts are scheduled to be contributors include:

Navigating Shifts in CDMO-Pharma Relations: Trends and Implications

, Faye Boeckman, senior director, market development, pharma services, Tuesday, Oct. 8, 11:35-12:30 CET, Hall 5 – 5B49

Fireside Chat: Navigating Outsourcing Partnerships for Start-Ups

, Kelly Howard, vice president, commercial operations, viral vector services global and advanced therapies, pharma services, Tuesday, Oct. 8, 13:15-13:40 CET, Hall 5 – 5B49

Optimizing ADC Processes: Advanced Strategies with High-Quality Bioreagents

, Dom Price, senior manager, technical sales, production chemicals and services–EMEA, bioproduction, Tuesday, Oct. 8, 13:45-14:10 CET, Hall 3 – 3F97

Development and Validation of Automated Rapid Protocols to Ensure Mycoplasma-Free Biologics

, Benjamin Ziehr, manager, cell lab, clinical research, Tuesday, Oct. 14:45-15:10 CET, Hall 5 – 5B49

Maximizing Outsourcing and Manufacturing Success Through Strategic CDMO and CRO Partnerships

, Jennifer Cannon, president, commercial operations, pharma services, Wednesday, Oct. 9, 13:45-14:10 CET, Hall 5 – 5B49 (1).

1. Thermo Fisher Scientific. Thermo Fisher Scientific Showcases Expanded Biopharma Services, Capabilities and Innovations at CPHI Milan 2024. Press Release. Oct. 7, 2024.
2. Thermo Fisher Scientific. Thermo Fisher Scientific Expands Clinical Research Laboratory in Wisconsin. Press Release. June 18, 2024.
3. Thermo Fisher Scientific. Thermo Fisher Scientific Completes Acquisition of Olink, Announces Commencement of Subsequent Offering Period. Press Release. July 10, 2024.

The introduction of Accelerator Drug Development follows expansions of sites in Cincinnati, Ohio, and Bend, Ore., earlier in 2024 to enable R&D, manufacturing, and testing.

Thermo Fisher Launching New CDMO, CRO Services at CPHI Milan

CPHI Milan 2024: Flavonoids in Pharmaceuticals

 sat down with Álvaro Nocete Díaz, Pharma Division Manager at HTBA, about the benefits of flavonoids and their use in the pharmaceutical industry. Nocete Díaz discusses how the flavonoid industry has developed, its future, and how to ensure quality when using flavonoids in pharmaceuticals.

“When you think about flavonoids, and again being phytochemicals, it is very important to think about the main source, which is normally a fruit, a vegetable, or an herb,” says Nocete Díaz. “So, the first stage in developing a flavonoid as an ingredient, either for the pharma or nutraceutical industry, will be to have a very strong and robust supply chain of those materials, because they come from crops, right? Then it is also very important to control the quality assurance.”

Nocete Díaz points to product standardization, identification, and quantification as important factors for quality assurance for flavonoids in pharmaceuticals. “[D]eveloping a method of analysis for those products is also very important when moving from the first stage of the natural source to a pure natural or active ingredient, which can be used in the pharmaceutical industry. [It is] also very important to consider the regulatory work that needs to be done, both from the agencies and from the industry, to control all [these aspects of quality],” Nocete Díaz says.

Pharmaceutical Technology® Europe sat down with Álvaro Nocete Díaz, Pharma Division Manager at HTBA, about the benefits of flavonoids and their use in the pharmaceutical industry. 

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.

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