Samir El Nasharty, Chief Operations Officer at Acino
Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. We deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets and leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing.
Acino is part of Arcera, a global company in the life sciences sector headquartered in Abu Dhabi, United Arab Emirates. Arcera was established by ADQ, an Abu Dhabi-based investment and holding company, to build a global life sciences powerhouse poised to make significant contributions to realising the UAE’s aspiration to emerge as a frontrunner in science and technology.
Q. How are you leveraging advanced manufacturing technologies, such as continuous manufacturing to enhance your production capabilities?
Acino is committed to delivering high quality products to its patients and customers. We achieve this by leveraging the strengths of each of our six manufacturing sites across four regions. By implementing Quality by Design, we are consistently fostering collaboration and synergies across our global network, utilising centralised systems and data science to optimise and automate our end-to-end manufacturing processes.
We are committed to making products accessible to our patients and customers in emerging markets and building and sustaining strong partnerships with our B2B customers in Europe. Through the strategic expansion and portfolio management, we have established ourselves as a key manufacturer in the generic pharmaceuticals market. We supply a wide range of medicines across various therapeutic areas, including cardiovascular health, CNS, pain management, catering to B2B clients.
Q. How are your sustainability initiatives influencing the development and production of pharmaceuticals? Or what green technologies are you showcasing at CPHI Milan?
Acino is committed to becoming carbon neutral by 2050. We are introducing activities in each of our sites to reduce Scope 1 and Scope 2 emissions to achieve this neutrality goal. These activities include implementing smart green labs, energy and heat loss recovery audits, numerous energy efficiency measures, waste reduction, recycling, reduction in water usage, better wastewater treatment, and moves to renewable energy sources like hydro-electric and solar. Currently, 28% of our total energy consumption comes from renewable sources.
Acino is a full member of the Pharmaceutical Supply Chain Initiative, and strongly supports the building of responsible supply chains in the pharmaceutical industry.
Q. What steps is your company taking to meet evolving regulatory requirements and ensure compliance, particularly in the context of global markets?
Acino has a Regulatory Intelligence Group equipped with a Regulatory Intelligence (RI) database. The team does the new legislation tracking and assesses its impact on the current and future portfolio and applies the right actions to meet all regulatory requirements and compliance.
The company is consistently building internal Regulatory (RA) and Quality Assurance (QA) capabilities to enhance internal expertise on the global level as well as in high-growth markets that we serve.
Acino collaborates closely with the healthcare authorities to ensure compliance, the development of new legislation in various regions and promotes educational initiatives.
Shaq Pan, SVP & GM, Ecolab Purolite Resins
Q. What key innovations or new products will your company be showcasing at CPHI Milan this year, and how do they address current industry challenges?
At CPHI Milan, we will showcase our advanced ion exchange and affinity resin toolboxes, which are designed to support a broad range of applications, including active pharmaceutical ingredients (APIs), excipients, and antibody purification. Additionally, we will highlight our expertise in optimising formulation development, enhancing manufacturing efficiencies, and helping to shorten development timelines. These capabilities not only demonstrate our commitment to innovation, but also position us as a reliable partner in helping clients accelerate their drug development processes. By working with industry executives, we continue to stay ahead of the latest trends and ensure we are addressing the most critical challenges in drug development and manufacturing.
Q. How are you leveraging advanced manufacturing technologies, such as continuous manufacturing to enhance your production capabilities?
Continuous manufacturing and process intensification are critical advancements that many pharma and biotech companies are considering with the ultimate goal of improving manufacturing efficiencies. Our investment in the new API / Excipient facility, located in King of Prussia, Pennsylvania, USA, not only helps to create a more secure and a reliable supply chain for our customers, but also provides them with the support needed for growth into new indications, markets, and drug products. We completed our first product technology transfer earlier this calendar year and have more on the horizon. This growth has solidified Ecolab and its teams as a significant player in the resin-based API and Excipients space.
Q. What steps is your company taking to meet evolving regulatory requirements and ensure compliance, particularly in the context of global markets?
Our regulatory team plays an active role in the Pharma industry, working closely with regulatory authorities to stay updated on the latest guidelines. By taking part in industry consortia, thought-leadership conferences, and engaging directly with customers, suppliers, and pharma companies, we help translate emerging regulations into agile, actionable solutions. Given the interconnected nature of global markets, regulatory changes in one region inevitably impact others, especially for international manufacturers.
Our mission is to provide customers with the tools needed to protect their drug products in compliance with evolving regulations across multiple markets. One example is our proactive monitoring of Nitrosamine regulations for our customers. By staying ahead of regulatory changes and providing necessary data to our customers, we drive a level of confidence that they will be able to meet all required standards.
Ecolab is also a member of Cefic’s SOIA (Synthetic Organic Ion Exchangers and Adsorbents) sector group, where we represent the interests of suppliers, manufacturers, and patients. Our participation in these discussions reflects our standing within the pharma community and underscores the value regulators place on our input. We are honoured to be invited to and partake in these conversations, which shape the future of the industry.
Q. How are your sustainability initiatives influencing the development and production of pharmaceuticals? Or what green technologies are you showcasing at CPHI Milan?
Sustainability initiatives are playing a critical role in reshaping pharmaceutical development and production, especially as companies face increasing pressure to reduce their environmental impact. Ecolab is supporting this shift by aligning its operations with ambitious 2030 sustainability goals that emphasise reducing energy and water consumption, two major challenges in the life sciences sector. The company is leading efforts to decarbonize supply chains by helping clients transition to renewable energy, implement circular supply chains, and adopt sustainable packaging solutions.
At CPHI Milan, Ecolab will showcase its technologies, including its patented bioprocessing resin manufacturing technology, which reduces environmental impact while maintaining efficiency in pharmaceutical manufacturing. These innovations are part of Ecolab’s broader mission to cut emissions across its own operations, purchased energy, and supply chains, while also promoting responsible packaging in healthcare and pharma facilities.
The life sciences sector’s heavy reliance on resources makes sustainability a business imperative, and Ecolab’s efforts are in line with wider industry trends towards adopting eco-friendly materials and processes. By focusing on sustainability, Ecolab is not only supporting environmental conservation but also driving innovation that will help pharma companies meet their production goals while reducing their ecological footprint.
Q. What role do partnerships and collaborations play in your company’s growth strategy, and how are you using CPHI Milan as a platform to build these relationships?
Collaborations have long been a cornerstone of growth within the pharmaceutical industry. This includes establishing manufacturing facilities in different regions and forming relationships with multiple sourcing channels. These strategies, coupled with market expansion within our pharma portfolio, provided rationale for our new API and Excipient facility in the U.S. to complement our current facility in Romania.
Quotient Sciences
Thierry Van Nieuwenhove – CEO
What key innovations or new products will your company be showcasing at CPHI Milan this year, and how do they address current industry challenges?
Enhancing our flagship Translational Pharmaceutics® platform remains a primary goal. Drug development typically necessitates involvement of both CDMOs and CROs, with transitions occurring at various stages throughout the process, often resulting in prolonged timelines. We consistently hear that no other business in our industry can demonstrate an approach quite like Translational Pharmaceutics®: integrating formulation development, on-demand and adaptive GMP manufacturing, healthy volunteer clinical testing, and data analysis. Applying our platform in either the US or UK gives clients greater flexibility; they may choose to either work with the FDA or MHRA to realize the benefits it delivers for their program. We are also extending our capabilities in preclinical development this year, which we provide directly from our facility in Nottingham, UK.
Q. What steps is your company taking to meet evolving regulatory requirements and ensure compliance, particularly in the context of global markets?
The industry is ever-evolving, and our teams are mindful of staying ahead of regulatory and scientific policy changes to ensure that we stay current and in continued compliance. Internally, we are committed to knowledge sharing among our teams, continuous learning and improvement. A recent example is the implementation of new FDA guidelines for conducting clinical pharmacology studies, which we’ve been monitoring for over 2 years to assess the impact on human ADME studies.
We are proactive members of trade organizations such as the ABPI, CCRA and EUCROF and other professional bodies like the Royal Society of Chemistry/Biology and Royal Pharmaceutical Society in the UK. As a UK/EU clinical research sector stakeholder, we’re often engaged with regulatory authorities to ensure our visibility and contribute to discussions that shape the future regulatory landscape.
Q. How are your sustainability initiatives influencing the development and production of pharmaceuticals? Or what green technologies are you showcasing at CPHI Milan?
Our commitment to environmental, social, and corporate governance initiatives are essential elements of our company strategy. Each year, we participate in an ECOVADIS assessment of our performance to help us to drive improvement year on year. For 2024, we are pleased to announce that we have improved our score by 10 points. This increase demonstrates our ongoing commitment to sustainability, and in recognition of that, EcoVadis also awarded us the Commitment Badge. This accolade highlights our dedication to sustainable practices across environmental, social and governance areas.
We have embraced ESG principles wholeheartedly and aim to develop our sustainability goals further in the years to come. We hold ourselves accountable, knowing that ethical practices build trust and resilience, and that by championing ESG we contribute to creating a better world for all.
Q. What role do partnerships and collaborations play in your company’s growth strategy, and how are you using CPHI Milan as a platform to build these relationships?
Our commitment to partnership and collaboration is reflected in how we approach every client program. An example is recent work with Vasa Therapeutics to help them reach a major clinical milestone with the first human subjects dosed at Quotient Sciences’ Nottingham, UK clinic for VS-041. VS-041 is in development as the first personalized medicine-based treatment of heart failure with preserved ejection fraction (HFpEF), or diastolic heart failure. Quotient Sciences’ Translational Pharmaceutics® platform was selected to accelerate the drug into first-in-human (FIH) trials. Dosing just began and is ongoing. We supported on-demand manufacture of an immediate release (IR) tablet that will allow for dosing and generation of clinical data in a shortened time.
Generally, you can also look at our approach to project management, too. Project management is a lynchpin of how we integrate activities across scientific functions to complete work with our clients. Our Project Managers control activities across functions and sites more varied than almost any other provider in our sector. We’re providing a single partner for our customers. It is something we are very proud of.
Another highlight has been our partnership with Charles River Laboratories. We know that going out of drug discovery and into pre-clinical and clinical development has challenges, including navigating multiple service providers. We’ve combined aspects of Charles River and Quotient Sciences’ capabilities in a single program of work to give clients deep scientific expertise and a bespoke service tailored to their development program.
Adragos Pharma
Marco Gorgas, Chief Technical Officer
What key innovations or new products will your company be showcasing at CPHI Milan this year, and how do they address current industry challenges?
At CPHI Milan this year, we are excited to present our expansion projects, including new manufacturing lines in Leipzig and Livron. These additions are set to make us one of the largest sterile liquids ampoules CDMO in Europe and are designed to significantly improve both efficiency and production capacity. Additionally, we want to showcase our Athens facility, exclusively dedicated to the development of generics, value-added medicines and new chemical entities (NCEs)
These improvements directly address industry challenges. The enhanced manufacturing lines improve our production scalability and flexibility, allowing us to meet increasing market demands more effectively. This addresses potential supply chain disruptions and helps ensure steady and reliable delivery of our products. And our Athens facility underscores our commitment to advancing pharmaceutical development.
Q. How are you leveraging advanced manufacturing technologies, such as continuous manufacturing to enhance your production capabilities?
We are leveraging advanced manufacturing technologies to significantly enhance our production capabilities across our different sites to even better address customers and patient’s needs. Here are some key updates:
New sterile injectables preparation and filling line in Livron: This year we worked on the launch of our new automated preparatory and cutting-edge ampoule filling line, designed to transform production at our site in Livron, France. This new line significantly boosts our production capacity, enabling us to produce over 150 million ampoules annually in various formats (1ml, 2ml, 5ml, 10ml, and 20ml). We started this line just recently with product transfers already underway with selected customers.
New Liquid Line in Leipzig: We are on track for our first commercial delivery in Q4 this year. This new line is designed to not only expand our capacity and product range but also to optimize our liquid production processes significantly. The new line will greatly improve our operational efficiency and speed, allowing faster turnaround times and higher throughput.
Bulk Reactivation Phase I and Phase II in Kawagoe: Our Kawagoe facility is reinvesting in solid dosage manufacturing to achieve a production capacity of 500 million tablets in Phase I, with a scheduled increase to meet the anticipated demand of 2 billion tablets in the next phases. Additionally, we are targeting the bio-pharmaceutical sector. Alongside manufacturing solid dosage forms, the Kawagoe site features advanced capabilities for inspecting and packaging 1.5 to 2 billion tablets and 15 to 20 million injectables annually.
Q. What steps is your company taking to meet evolving regulatory requirements and ensure compliance, particularly in the context of global markets?
We can mention 3 main areas where we are making progress to ensure the safety, quality, and reliability of our products globally.
- FDA Readiness: Our facilities in Athens and Kawagoe are fully prepared to comply with FDA regulations. Our site in Halden, Norway, is FDA approved already. This readiness ensures that our products meet stringent U.S. regulatory standards, maintaining high levels of safety and efficacy.
- European Standards: Our facility in Livron has been upgraded to meet the Annex 1 regulatory requirements in France. This compliance underscores our dedication to adhering to advanced regulatory standards in Europe.
- In-House Expertise: We have established a specialized regulatory team based in Athens. This team is tasked with staying abreast of regulatory changes, ensuring that our products and processes remain compliant with both local and international regulations. Their expertise allows us to swiftly adapt to new regulatory landscapes and maintain a high level of compliance across all markets.
Q. How are your sustainability initiatives influencing the development and production of pharmaceuticals? Or what green technologies are you showcasing at CPHI Milan?
In Adragos we are dedicated to incorporating sustainable practices to minimize our environmental footprint. To minimize the environmental impact of our operations, we committed to SBTI (Science Based Targets initiative).
In addition to this, we have installed solar panels in Leipzig to reduce our reliance on non-renewable energy sources.
Other ESG initiatives are focused on minimizing environmental impact, increasing product accessibility, ensuring employee satisfaction, maintaining supply chain responsibility, and promoting integrity within operations.
Q. What role do partnerships and collaborations play in your company’s growth strategy, and how are you using CPHI Milan as a platform to build these relationships?
As a global CDMO, our mission is to provide end-to-end development and manufacturing services across a diverse range of pharmaceutical needs. To achieve this, we actively seek strategic partnerships that align with our expertise, strengthening the service offerings of our partners and expanding our global reach.
CPHI Milan provides an excellent platform to foster these relationships. We will be actively engaging with our customers and suppliers, with a dedicated team of 18 people at our booth. This event allows us to connect directly with current but also potential new partners and clients, showcase our capabilities across our production sites in France, Germany, Norway, Japan, and Greece, and explore new collaboration opportunities. By leveraging CPHI Milan’s network, we aim to build long-term partnerships that enhance our production technologies, broaden our customer base, and drive mutual growth within the industry. We look forward to sharing the impressive growth we have achieved and the upcoming expansions on the horizon.
Nigel Stapleton, Vice President of Business Development – Head of Europe at Mabion.
Q. What key innovations or new products will your company be showcasing at CPHI Milan this year, and how do they address current industry challenges?
Mabion entered the CDMO market just two years ago, but we bring nearly two decades of experience in developing our own products. This deep background gives us a unique perspective and a clear understanding of our clients’ needs, having been in their position ourselves not long ago. Our experience developing biosimilars has helped us to offer a comprehensive suite of services all under one roof.
Many CDMOs in the industry today lack direct experience in product development. Additionally, several of the bigger CDMOs do not offer the comprehensive range of services that Mabion provides. This addresses two key industry challenges:
First, having first hand experience in product development allows us to understand our clients’ needs from their perspective, leading to a more focused and informed approach. Second, by offering a broad package of services, we reduce the need for outsourcing, giving us more control over both costs and project timelines.
This combination of client understanding and integrated services contributes to a more streamlined process, helping ensure that projects are completed on time and within budget.
Q. How are you leveraging advanced manufacturing technologies, such as continuous manufacturing to enhance your production capabilities?
Our scientists are actively engaged in researching and evaluating emerging technologies, such as perfusion systems, continuous manufacturing, and other advanced production methods. While we remain committed to staying at the forefront of innovation, our focus as a service provider is making sure that we meet the needs of our clients because that is central to everything we do.
All of our services are tailored to meet the specific requirements of each client. Rather than offering standardized solutions, we prioritize customization, working closely with our partners to deliver outcomes that align precisely with their goals. This approach helps us to provide more effective, client-focused solutions that are flexible and responsive to the unique challenges of each project.
Q. What steps is your company taking to meet evolving regulatory requirements and ensure compliance, particularly in the context of global markets?
As a European-based organization, our primary focus is ensuring full compliance with EU GMP standards. However, we remain acutely aware of the regulatory frameworks set by authorities in other regions, particularly given the evolving global landscape. With the passage of the BioSecure Act in the US and Europe’s initiative to strengthen domestic manufacturing capabilities, it has become increasingly important for us to adhere to a broad range of international regulations.
Q. How are your sustainability initiatives influencing the development and production of pharmaceuticals?
The ability to manage risks effectively is a critical consideration in the biopharma industry. To mitigate potential product risks, we exclusively use single-use consumables. While this approach may initially appear unsustainable due to its associated waste, it ultimately prevents the loss of product, which could result in even greater waste.
Within our commitment to risk avoidance, Mabion continuously seeks opportunities to reduce energy consumption and implement recycling and reuse practices where feasible and responsible. We recognize the importance of sustainability in our operations; however, our priority is always product quality and patient safety. Through this approach, we aim to contribute positively to both the industry and the environment.
Q. What role do partnerships and collaborations play in your company’s growth strategy, and how are you using CPHI Milan as a platform to build these relationships?
Partnerships are central to our corporate growth strategy at Mabion. Our team recognizes that we collaborate with highly motivated biopharma companies, and we are committed to building strong relationships with our clients on both professional and personal levels. We prioritize flexibility and strive to fully understand their needs to ensure we provide tailored support.
At CPHI, we look forward to engaging face-to-face with both current clients and prospective partners. These interactions provide valuable opportunities to deepen our relationships, gain insights into what matters most to our clients, and ensure that our services consistently meet their expectations.
Q. What key innovations or new products will your company be showcasing at CPHI Milan this year, and how do they address current industry challenges?
Dr. John Cameron, Director, Global Injectables Platform said, “CordenPharma is proud to launch a fully-integrated Lipid NanoParticle (LNP) offering from three sites within our facility network. This supports the growing customer demand for effective xRNA-based drug development, including targeted gene therapy.
Our streamlined approach offers cost effective, end-to-end supply of all the components needed to develop and manufacture clinical to commercial LNP therapeutics. This includes standard and custom Lipids and nucleic acid manufacturing, LNP formulation development and GMP manufacturing, as well as sterile Fill & Finish into vials or PFS at clinical and commercial scale.”
Dr. Brittany L. Hayes, Director Highly Potent & Oncology Platform commented, “Our CordenPharma Plankstadt (DE) facility has become our Drug Product Innovation Centre of Excellence for the development and manufacturing of OSD products. We have added enabling technologies such as spray drying, hot melt extrusion, nanomilling, micronization, and co-precipitation to enhance bioavailability and enable the formulation of NMEs with challenging properties – such as peptides and small molecules with limited solubility, permeability, very low drug load, high potency, and limited stability – into highly complex Oral Solid Dose drug products.”
Q. How are you leveraging advanced manufacturing technologies, such as continuous manufacturing to enhance your production capabilities?
Dr. Ilia Freifeld, Director of CordenPharma’s Small Molecules Platform commented: “At CordenPharma, we are not a “Flow-at-all Cost” company. We look to identify and incorporate the most advantageous use of flow chemistry on projects to solve customers’ fundamental concerns or address deficiencies, specifically when it comes to process safety, process intensification, value risk mitigation, reaction profile/outcome, and exposure to unique and green/environmental chemistry. As a result, we will often propose hybrid solutions to a chemical synthesis combining batch processing around a specific flow mode step.”
Enzene
Russell Miller, Vice President, Global Sales and Marketing, Enzene
Q. What key innovations or new products will your company be showcasing at CPHI Milan this year, and how do they address current industry challenges?
We’re showcasing our latest innovation in fully-connected continuous manufacturing – EnzeneX™ 2.0. An evolution from the conventional fed-batch processes, fully-connected continuous manufacturing (FCCM) provides uninterrupted processing from perfusion to final drug substance, streamlining production and mitigating risks associated with batch-to-batch transfers.
FCCM offers :
- Significantly decreased COGS: EnzeneX™ 2.0 is redefining the economics for FCCM, expecting to deliver 40kg/1000L batch at $40/gram by 2025. The lower operational costs and higher productivity can enable up to 50% reductions in overall cost per gram .
- Higher titer clones: EnzeneX™ 2.0 offers maximum protein yield per cell line, ensuring superior productivity. FCCM can achieve up to 10x increases in product yield compared to fed-batch.
- Optimized cell media: Tailored media formulations boost cell productivity and efficiency.
- Process Analytical Technology (PAT): Enables real-time monitoring and control for consistent quality and optimized processes.
- Enhanced product quality: Continuous extraction of the product from the bioreactor mitigates the risk of contact with harmful metabolites and proteolytic enzymes resulting in higher product quality, even for proteins that are less stable or challenging to express.
- Greater sustainability: The decreased equipment footprint allows for reduced facility size and up to 50% reduction in carbon emissions.
Q. How are you leveraging advanced manufacturing technologies, such as continuous manufacturing to enhance your production capabilities?
Through partnerships with innovators and biologics developers, EnzeneX™ 2.0 can deliver accelerated time-to-market, increased production yields and cost reductions across a broad range of modalities. Committed to pushing the boundaries of biologics manufacturing innovation, we are continuously optimizing fully-connected continuous manufacturing (FCCM) to reduce monoclonal antibody production costs to below $40 per gram by 2025. Overall, FCCM allows us to produce biologics with improved quality, efficiency and flexibility, ultimately benefiting patients by providing faster access to high-quality treatments.
