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    Company profile for ICE Pharma

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    ICE Pharma joined the fifth edition of “Fabbriche Aperte”

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    The potential of bile acids as anti-COVID-19 therapies

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    ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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    ICE Pharma's core business includes the manufacture of active pharmaceutical ingredients, the most important of which is Ursodeoxycholic Acid (UDCA), used to treat liver diseases and gallstones. The company develops and manufactures a range of bile acid derivatives that are used as excipients, nutraceutical ingredients, cell culture media, and intermediates. ICE Pharma also provides contract manufacturing services for liquid and solid finished dosage forms for branded and generic products. Since October 2019, ICE Pharma has been owned by Advent International, one of the largest and most experienced global private equity investors.

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    INTERVIEW #SpeakPharma

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    "ICE is pioneering sustainability, innovation in bile acid research for neurodegenerative diseases"

    "ICE is pioneering sustainability, innovation in bile acid research for neurodegenerative diseases"

    This week, SpeakPharma interviews Roger Viney, Chief Commercial Officer of ICE Pharma, a world-leading manufacturer of specialty biliary acid products with a focus on innovation, environmental responsibility, and a strong company culture. Viney discusses the company’s ambitious sustainability targets, and its exciting research into bile acids’ potential in treating neurodegenerative diseases like Parkinson’s.  🔑 HIGHLIGHTS// focus on innovation, environmental responsibility, and a strong company culture ICE Pharma has set four strategic pillars to guide its sustainability efforts. Can you tell us what these four pillars are and how they contribute to the long-term resilience of the business and its supply chain? In 2022, we developed a comprehensive long-term sustainability strategy, accompanied by a short-term roadmap to guide our actions over the next three years. This outlines the strategic choices that will define our way forward and details the progress we are making against our roadmap. Our sustainability strategy is designed to bolster the long-term resilience of our business and supply chain, provide a source of fulfillment for our employees and enable our customers to continue developing and delivering treatments for hepatic and neurological diseases, as well as other conditions that respond to bile acid-based therapies. By contributing holistically to a healthier society and environment, our strategy aims to create long-term value. We aim to maximize our positive impact on health by opening our Biliary Acid Library of potential new molecules to further the development of these treatments. Additionally, we strive to reduce our environmental footprint by creating products with fewer raw materials, diversifying the animal sources we use, and exploring new plant-based bile acid derivatives. We have established clear targets along four strategic pillars, supported by robust ESG governance and leadership. Firstly, we are committed to fighting illness through product innovation. By providing innovative, safe, and high-quality pharmaceutical ingredients, we help our customers build a healthier society. Secondly, we focus on accelerating sustainable operations by monitoring and reducing our emissions, energy, and water consumption through robust ESG processes and accountability. Thirdly, we prioritize building strong relationships by managing our supply chain transparently, fostering strong supplier relationships, and adhering to responsible business practices. Lastly, we are dedicated to caring for people by cultivating a transformational and inclusive culture that ensures the well-being and development of our employees. 🔑 HIGHLIGHTS// Biliary Acid Library of potential new molecules / robust ESG governance and leadership / manage our supply chain transparently ICE Pharma has committed to an ambitious sustainability plan. Can you elaborate on specific targets it has set to reduce greenhouse gas (GHG) emissions and increase the use of renewable energy? Also, what significant investments have ICE made or plans to make to support these goals? ICE’s carbon footprint aligns with industry standards in the pharmaceutical and API sectors in terms of GHG emissions. We have set an internal target that is challenging yet achievable and aligned with our business objectives – a 20 percent reduction in Scope 1 and 2 emissions (majorly energy-related) and a 30 percent reduction in Scope 3 emissions (from solvents, reagents, and animal byproducts used as raw materials) by 2033. We plan to achieve these targets through two main approaches. For electric power, we aim to achieve 100 percent renewable energy utilization by 2030, and we are well on track to achieve this. We are heavily investing in renewable sources, either through sourcing green energy or through in-house investments in photovoltaic (PV) systems at our factories. Fortunately, the significant growth in installed renewable capacity across all geographies where we operate makes this goal both achievable and financially sustainable. However, a substantial portion of our energy consumption comes from generating heat involved in our processes. To counter this, we are focusing on energy efficiency, targeting over 90 percent of our energy consumption to be covered by ISO 50001 standards, and investing heavily in more efficient technologies. For Scope 3 emissions, our efforts are concentrated on further developing our processes to reduce the amount of chemicals used, improve our yields, and switch to animal-source raw materials with a smaller carbon footprint. 🔑 HIGHLIGHTS// internal target that is challenging yet achievable / 100 percent renewable energy utilization by 2030 ICE Pharma highlights its strong company culture as one of the secrets to its success. Can you speak on how you foster a collaborative and respectful work environment, and how these efforts contribute to the company’s overall success? At ICE Pharma, we place great emphasis on building a collaborative and respectful work environment, recognizing it as a key driver of innovation and success. Our culture is fostered by our Cultural Pillars: Unity, Evolution, and Achievement. These pillars shape our approach in several key areas. Firstly, we value diversity and inclusion. Operating across different cultural contexts and geographies, we have gathered a diverse range of ethnicities. We actively ensure that all voices are represented. This promotes a culture where everyone is respected for their unique perspectives. Secondly, recognizing employee contributions is fundamental to our approach. ICE Pharma celebrates achievements and milestones, ensuring that employees feel valued. We also support professional development and personal growth of employees through initiatives such as secondments and international mentoring programs, and financial support for excellence training courses. This creates motivation and loyalty, reinforcing a positive company atmosphere. Thirdly, we understand the importance of work-life balance. We promote policies that allow employees to maintain a healthy equilibrium between their professional and personal lives, with a special focus on parenthood. This respect for individual well-being translates into a happier, more engaged workforce. By fostering these values, we create a work environment that drives productivity, encourages innovation, and strengthens the company’s overall success. 🔑 HIGHLIGHTS// value diversity and inclusion / recognize employee contributions / understand the importance of work-life balance Considering the unique properties of bile acids, can you discuss how ICE Pharma is leveraging its technology to develop innovative drug delivery systems for emerging therapies or to address challenges with existing medications? We are thrilled about the expanding role of bile acids in medicine. ICE Pharma holds a unique position, being deeply involved in fundamental research, developing new bile acids, bringing them into clinical trials, and manufacturing generic medicines based on these compounds. Recent research has highlighted the role of bile acids as metabolic regulators, revealing their potential to treat a variety of diseases. They have emerged as an excellent class of molecules for targeting metabolic conditions such as type 2 diabetes, obesity, and non-alcoholic fatty liver disease (NAFLD). Bile acids are now known to act on several nuclear receptors, and it is becoming clear that their signaling properties are complex and extend beyond the FXR and TGR5 receptors, where most current research is focused. One particularly exciting area of interest is the potential of bile acids in treating neurodegenerative diseases. In collaboration with the Ferrier Institute, we have contributed to research on Parkinson’s disease. Mitochondrial dysfunction is a well-documented mechanism in both sporadic and familial Parkinson’s disease. Ursodeoxycholic acid (UDCA) has been identified as a bile acid that enhances mitochondrial function in multiple in vitro and in vivo models of Parkinson’s disease. Our studies indicate that modified novel bile acid molecules could lead to the development of more efficacious treatments that improve mitochondrial function and overall cellular health, presenting promising new therapeutic options for Parkinson’s disease. 🔑 HIGHLIGHTS// potential of bile acids in treating neurodegenerative diseases / contributed to research on Parkinson’s disease / present promising new therapeutic options Given ICE Pharma’s commitment to the highest quality and regulatory compliance standards, can you elaborate on how the company ensures that these standards are consistently maintained, especially when dealing with the complexities of animal-derived products? At ICE, we place great emphasis on controlling pathogens in our animal-derived products, ensuring safety and quality throughout the entire supply chain, from the collection of bile to the finished product. The bile is sourced exclusively from authorized countries, and each production batch is meticulously traced to certify that every animal has been raised and sacrificed according to specific guidelines. The initial step in bile processing involves a treatment that certifies the product as TSE/BSE Free. This is followed by at least two additional stages, based on experimental studies conducted by specialized laboratories, which are effective in inactivating viruses. Intermediates and the final product are handled in closed cycles or in contamination-controlled areas (ISO-8 cleanrooms). Beyond these fundamental aspects, ICE is deeply committed to keeping its dossiers up to date with the latest guidelines and constantly monitoring trends in analytical data to ensure consistent product quality. Where possible, we enhance this quality through a change control plan carefully managed by our Quality Assurance team. Staff training, predictive and preventive maintenance plans, equipment qualification, and process validation are crucial activities involving the entire workforce with the support of the Quality Unit. Our commitment to continuous improvement drives us to focus on digital globalization to ensure ever-greater transparency and reliability in the data that supports our work. As John Ruskin said, “quality is never an accident. It is always the result of intelligent effort.” We continue to follow this philosophy in our daily commitment. 🔑 HIGHLIGHTS// bile is sourced exclusively from authorized countries / each production batch is meticulously traced / ensure ever-greater transparency and reliability

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    Product List 2023

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    GMP Certificate 2024

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    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   
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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for