Susan Haigney

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

In a joint statement on Oct. 8, 2024, Colorcon, a specialty excipients company, and LOTTE Fine Chemical, a specialty chemical company, announced they were partnering to develop and manufacture drug and dietary supplement products using LOTTE’s AnyCoat Hypromellose products. Through the partnership, Colorcon will have exclusive representation of LOTTE’s AnyCoat-C Hypromellose polymers, used in solution/suspension, controlled-release, and immediate-release formulations; and AnyCoat-P Hypromellose Phthalate polymers, used for enteric coating to deliver a drug safely into the intestines.

“Colorcon is proud to announce our partnership with LOTTE Fine Chemical as we continue to support the formulation development needs of our customers around the world,” stated Kurt Fegely, vice-president of Excipient Technologies for Colorcon, in the press release (1). “LOTTE has been a leader in the specialty chemical industry for more than six decades and they have continued to innovate and evolve during that time. This partnership combines an impressive product portfolio for immediate, delayed, and controlled release with a global network of technical innovation and service that will accelerate formulation development, helping our customers compete in an increasingly competitive market.”

“This agreement is significant in that it represents a long-term collaboration in the pharmaceutical cellulose ether market between recognized market leaders. Through this relationship with Colorcon, an organization with proven expertise and leadership in the pharmaceutical industry, we will be able to deliver the most optimized value to our global customers,” Kim Yong-seok, chief executive officer for LOTTE Fine Chemical, added in the release.

“We are excited to bring together LOTTE Fine Chemical’s expertise in cellulose ether chemistry—and their commitment to high quality manufacturing—with Colorcon’s 60+ years of dedication to service excellence, supply reliability, and technical applications support,” said Simon Tasker, chief executive officer for Colorcon (1). “Our combined offering positions us to bring enhanced value to our customers and is a clear demonstration of our commitment to the global pharmaceutical and nutraceutical industries.”

 recently spoke with Ali Rajabi-Siahboomi, vice-president and chief innovation officer at Colorcon, about the evolution of coating design and how it has impacted investment, as well as innovations in packaging for oral solid dosage products (2). Coating design for solid dosage products has evolved from sugar coating to film coating to solvent-based and then to aqueous coating over the years, according to Rajabi-Siahboomi.

“But the development of this robust and optimized formulation that we've had, and the umbrella of open dry system, has made it much easier to have the right film coating, but at the same time, apply it much more efficiently and take that on board with the increasing population,” he says. “Therefore, there is an increasing demand on making sure that the tablets coming into the market are coated.”

PharmTech.com/view/cphi-milan-2024-evolution-of-coating-design to watch the interview with Ali Rajabi-Siahboomi

Colorcon is showcasing its products at Booth 6D58 at CPHI Milan, which is being held from Oct. 8–10, 2024 in Milan, Italy.

Colorcon. Colorcon and LOTTE Fine Chemical Announce Global Partnership to Support the Development and Manufacture of Pharmaceutical and Dietary Supplement Formulations Using the AnyCoat Hypromellose Product Family. Press Release. Oct. 8, 2024.

Thomas, F. CPHI Milan 2024: Evolution of Coating Design. 

Articles

Through the global partnership, Colorcon will exclusively represent LOTTE’s AnyCoat Hypromellose products.

Colorcon and LOTTE Fine Chemical Announce Partnership

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

The winners of this year’s awards showcase achievements in pharma excellence.

Winners of CPHI Excellence in Pharma Awards Announced

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

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.

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

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. 

The contract development and manufacturing organization (CDMO), Enzene, will be launching its new fully-connected continuous manufacturing platform for biologics at the CPHI Milan show, being held from Oct. 8–10, 2024 in Milan, Italy. The EnzeneX 2.0 is a patented platform that provides uninterrupted processing from perfusion to final drug substance.

The technology uses high titer clones to improve productivity and target protein concentrations, streamline production, and mitigate risks associated with batch-to-batch transfers. The platform also boosts cell productivity by leveraging optimized cell media. Process analytical technology is used to enable real-time monitoring and control quality.

“Enzene continues to lead the industry in launching innovative approaches to maximize product yield while minimizing COGS [cost of goods]. Our latest innovation in fully connected continuous manufacturing can be tailored for a broad range of modalities and media formulations to boost cell productivity and efficiency,” said Himanshu Gadgil, CEO of Enzene, in a press release. “Lower operational costs and higher productivity can enable up to 50% reductions in overall production cost per gram, and we are on target to achieve a game-changing benchmark by 2025. We expect that our FCCM [fully connected continuous manufacturing] will be able to deliver 40 kilograms per thousand-liter batch at $40-per-gram.”

EnzeneX 2.0 can also reduce equipment footprint compared to fed-batch systems, according to the company. It can handle clinical-phase current good manufacturing practice supply from 30-L scale. The modular design has variable bioreactor capacity and can take on scale-on and scale-out expansion.

Enzene is launching a new facility in Hopewell, NJ, to be operational in early 2025, that the company said will provide a fully connected service. “Enzene Biosciences is thrilled to establish our manufacturing operations in New Jersey, as it allows us to extend our local manufacturing capabilities to our valued North American clients,” said Gadgil at the time of the facility announcement (2). “We are excited to provide them with access to our cutting-edge continuous manufacturing platform, which enables streamlined and efficient production processes. New Jersey’s highly skilled workforce, state-of-the-art infrastructure, and renowned academic institutions make it an ideal location for Enzene, ensuring that we can deliver exceptional services and support to our clients in the [United States].”

® spoke with Gadgil in June 2024 about the benefits of continuous manufacturing of biologics. Gadgil talked about the impact on a company’s cost of goods, and stated, “For example, in a 1500-square-foot cleanroom, we can manufacture in a month currently around 10 kilograms of mAbs [monoclonal antibodies], and we are enhancing that platform where we should be able to manufacture on 40 kilograms of mAbs.” Gadgil continued, “So, one of the biggest advantages of continuous manufacturing is cost of goods, because the operational cost is much lower than the conventional manufacturing, [because] the footprint is more compact, and at the same time, the productivity is also very high.” He also said, “Because when you do perfusion, you get significantly higher cell densities almost five to 10 times higher cell densities than the conventional fed batch” (3).

Enzene can be found at CPHI Milan at stand 5D63, Hall 5.

1. Enzene. Enzene Launches EnzeneX 2.0. Press Release. Oct. 4, 2024.
2. Choose New Jersey. Enzene Biosciences Expanding to New Jersey with $50M Investment in Bio Manufacturing Plant. June 15, 2023.
3. Haigney, S. Continuous Manufacturing and Cost of Goods (BIO 2024). 

The CDMO will be launching its EnzeneX 2.0 continuous manufacturing for biologics technology during CPHI Milan, which is being held Oct. 8–10, 2024 in Milan, Italy.