Ardena operates two facilities in Oss, Netherlands. Our Pivot Park site covers drug substance development and manufacturing, solid state research, and bioanalysis. Our Kloosterstraat site is a purpose-built 2,200 m² nanomedicine facility, constructed to GMP Annex 1 standards with advanced cleanrooms, integrated development and analytical labs, and dedicated warehousing. Two sites, one integrated team — combining the scientific depth your molecule needs across chemistry, solid state, bioanalysis, and nanomedicine under one coordinated program.
Facility Details
Address
Kantsingel 32
5349 AJ Oss, Netherlands
+31 412 846 024
Kloosterstraat 9
5349 AB Oss
Netherlands
+31 412 226 010
María Jesús Martín is Senior Scientist and Group Leader in the Solid-State Department at Ardena Oss. She combines scientific expertise in solid-state science with project management experience across pharmaceutical development environments.
Before joining Ardena in 2022, María Jesús began her career in solid-state science at Pharmorphix in Cambridge and later moved into project management roles within the pharmaceutical industry. At Ardena, she combines her scientific and project management background to support Solid-State Department activities and customer projects.
María Jesús studied Chemistry in Zaragoza, Spain, and completed her MChem studies in Edinburgh, United Kingdom.
Giovanna Brancatelli is Principal Scientist and Scientific Director at Ardena Solid State Research in Oss. She supervises R&D projects focused on polymorph, salt, and co-crystal screening, as well as preformulation studies supporting pharmaceutical development programs.
Giovanna joined Ardena in 2015 from the Department of Chemistry at the University of Trieste, where she conducted postdoctoral research on the molecular recognition of biogenic amines in the solid state. Her expertise includes polymorphism, crystallization, organic and inorganic chemistry, supramolecular chemistry, and X-ray crystallography.
Giovanna earned her MSc degree and PhD in Chemical Sciences from the University of Messina.
GMP Scale-Up
Nanomedicine Process Development
Polymer Sciences
Rob van der Weegen is Principal Scientist and Group Lead at Ardena. He specializes in GMP-compliant process development and scale-up of complex nanoscale therapeutic modalities supporting clinical studies and future commercial manufacturing.
Rob joined Ardena in 2018 as a Process Development Scientist in the field of Nanomedicines. Since then, he has focused on supporting process development and manufacturing scale-up activities for advanced therapeutic programs within GMP-regulated environments. Prior to joining Ardena, he completed a two-year postdoctoral position in Paris specializing in polymer and materials sciences.
Rob obtained his PhD in Supramolecular Chemistry from Eindhoven University of Technology in 2015.
Analytical Sciences
CMC Development
Regulatory Readiness
Moniek van der Eem is Director Analytical Sciences at Ardena. She is an experienced analytical chemist with more than 20 years of experience in the pharmaceutical industry, specializing in CMC development and analytical strategies supporting drug development programs.
Throughout her career, Moniek has led analytical and quality strategies across complex pharmaceutical projects, supporting the advancement of development programs from early stages into the clinic. She has extensive experience delivering robust analytical data packages and supporting regulatory readiness across development activities.
Moniek is recognized for her expertise in analytical sciences and her focus on supporting efficient and compliant pharmaceutical development programs.
Sjoerd Rijpkema is Senior Scientist and Group Lead at Ardena. He specializes in polymer chemistry and NMR, supporting R&D activities and customer projects within pharmaceutical development programs.
Before joining Ardena, Sjoerd worked as a university lecturer, teaching polymer chemistry and NMR. Since joining Ardena, he first worked in laboratory-based roles before progressing into his current position as Group Lead in R&D, where he supports customer projects and team coordination activities. In addition to his work at Ardena, he is a columnist for the Royal Netherlands Chemical Society (KNCV) and is involved in the organization committee for the Future Leaders in Chemistry conference.
Sjoerd studied Chemistry in Nijmegen, where he completed a Master’s degree in Organic Chemistry and NMR, followed by a PhD in Systems Chemistry.
Multidisciplinary Programs
Pharmaceutical Development
Project Management
Marco Jaspers is Principal Scientist and Senior Project Manager at Ardena. He brings more than 20 years of experience across the life sciences and pharmaceutical industry, specializing in leading complex multidisciplinary projects.
Throughout his career, Marco has focused on supporting project teams and clients in delivering successful development outcomes across pharmaceutical programs. He is recognized for his results-driven mindset, pragmatic approach, and empathetic leadership style, supporting collaboration across cross-functional project environments.
At Ardena, Marco works closely with project teams to help accelerate development programs and support the successful progression of products toward market readiness.
Nanomedicine Development
Pharmaceutical Manufacturing
Process R&D
Director Process R&D and Manufacturing Nanomedicines
Silvie Meeuwissen is Director Process R&D and Manufacturing Nanomedicines at Ardena Oss. She specializes in nanomedicine process development and pharmaceutical manufacturing, supporting the development of innovative precision medicine-based therapies.
Since joining Ardena in 2013, Silvie has played a key role in the establishment and growth of Ardena’s nanomedicine services. In 2023, she became Director Process R&D and Manufacturing Nanomedicines, leading the department’s efforts in process development and manufacturing activities supporting advanced therapeutic programs.
Silvie studied Organic Chemistry and obtained her PhD in Bio-organic Chemistry from Radboud University.
Ardena Somerset
About This Facility
Welcome to Ardena Somerset
Ardena Somerset is our US center of science and manufacturing – and it does more than most CDMO sites its size. The facility houses 200+ scientists, engineers, and operations specialists serving as a Center of Excellence for advanced oral dosage forms, including hot melt extrusion and solubility enhancement for poorly soluble drugs. FDA registered, DEA licensed, and cGMP compliant, it supports late-stage and small-scale commercial manufacturing for controlled substances and complex molecules.
In April 2026, Ardena opened a new state-of-the-art bioanalytical laboratory at Somerset — 2,500+ sq ft of operational lab space with LC-MS/MS systems, immunochemistry platforms, and controlled sample storage. The lab supports quantitative analysis for preclinical and clinical studies across small molecules, biologics, ADCs, and biomarker programs, bringing Ardena’s European bioanalytical depth directly to North American clients. Additional platforms including qPCR and flow cytometry are being added in the coming months.
Two capabilities. One site. Coordinated by scientists who own innovation.
Facility Details
Address
14 School House Road
08873 Somerset, United States
(732) 231-2201
Joseph Ju is Director of Continuous Improvement at Ardena Somerset. He brings more than 13 years of experience in the CDMO pharmaceutical manufacturing industry, with expertise spanning cGMP clinical and commercial manufacturing operations, process optimization, and operational excellence.
At Ardena, Joseph oversees cGMP clinical and commercial manufacturing operations in Somerset, focusing on continuous improvement initiatives and scalable manufacturing performance. Throughout his career, he has led commercial operations teams supporting operational efficiency and sales growth within regulated pharmaceutical manufacturing environments.
Joseph obtained both his Master of Science and Bachelor of Science degrees in Biomedical Engineering from the New Jersey Institute of Technology.
Hibreniguss (Hibre) Terefe, PhD, is Director of Product Development and Site Head of R&D at Ardena Somerset. He leads integrated preformulation, formulation R&D, and analytical R&D teams supporting drug product development programs from early-stage enabling technologies through Phase III and commercial launch.
Hibre brings more than 20 years of pharmaceutical industry experience in oral drug delivery systems and drug product development. His expertise includes hot melt extrusion, solubility enhancement, amorphous solid dispersions, modified release technologies, pediatric formulations, and abuse deterrent platforms. Throughout his career, he has combined scientific expertise with strategic and organizational leadership to support efficient and milestone-driven development programs. He is also recognized as an industry thought leader in oral drug product development and CMC strategy, with more than 15 publications across industry and scientific journals, contributions to the Handbook of Pharmaceutical Granulation Technology, and involvement as co-inventor on 10 patents and patent applications related to drug delivery technologies.
Hibre obtained his pharmacy degree and earned his PhD in Pharmaceutical Chemistry, with an emphasis in Analytical Chemistry, from Westfälische Wilhelms-Universität Münster, Germany. He also served as a Fulbright Visiting Scholar at the University of California, Berkeley.
Phillip Santos is Engineering Director at Ardena Somerset. He brings more than 20 years of experience in the pharmaceutical industry, with expertise spanning process equipment, facilities management, and GMP manufacturing across multiple small molecule dosage forms.
Throughout his career, Phillip has built and led high-performing engineering teams and supported complex programs within regulated manufacturing environments. At Ardena, he is responsible for engineering operations across the Somerset site, supporting operational efficiency and manufacturing activities within GMP-regulated environments.
Phillip is recognized for his leadership in engineering operations and his experience managing technical and operational activities across pharmaceutical manufacturing facilities.
Peggi Gosha is Director of Supply Chain at Ardena Somerset. She brings more than 23 years of experience across medical device manufacturing and the pharmaceutical industry, with expertise in supply chain operations within regulated manufacturing environments.
Throughout her career, Peggi has focused on building scalable and compliant processes that support inventory control, operational efficiency, and cross-functional alignment. At Ardena, she leads supply chain strategy for the Somerset site, supporting GMP operations and the expansion of bioanalytical services.
Peggi is recognized for driving strategic initiatives, implementing structured systems, and supporting audit-ready operations within highly regulated environments.
Contamination Control
GMP Quality Systems
Microbiology
Neil Eppinger is Interim Associate Director of Analytical Services at Ardena Somerset. He brings more than 20 years of experience in pharmaceutical quality, specializing in microbiology and controlled environments within cGMP-regulated clinical and commercial manufacturing facilities across diverse product portfolios and cleanroom classifications.
In his current role, Neil leads analytical and microbiological quality control programs, including environmental monitoring, stability and sample coordination, cleaning verification and validation, and contamination control strategies. Throughout his career, he has supported regulatory inspections conducted by the FDA and international agencies and has performed quality inspections of suppliers and intercompany sites. He also brings extensive experience conducting complex microbial investigations to ensure compliance with global regulatory standards.
Neil is recognized for his leadership of cross-functional teams, commitment to data integrity, and focus on risk-based quality strategies that support continuous improvement, operational excellence, and patient safety.
Ian joined Ardena in 2025 as US Managing Director. He has over 30 years of global experience across multiple functions in both the CDMO and Medical device industry. Ian spent 19 years of his career working at GE in Quality, Finance, Supply Chain, Technical services and Commercial operations. He then joined Catalent in 2013 where he was VP of Sales Operations and more recently GM for the Somerset site. He holds degree in Mechanical Engineering and an MBA from Northwestern University – Kellogg School of Management.
Ardena Assen
About This Facility
Welcome to Ardena Assen
Ardena Assen is a highly specialized and innovative facility offering a full range of bioanalytical services from drug discovery research to phase IV clinical studies.
With advanced labs and a team of 90+ experts, we specialize in analyzing small molecules, proteins, vaccines, and more, delivering precision science in an inspiring, collaborative atmosphere.
Gunnar Flik joined Ardena in 2024 as Division Head of Bioanalytical Services. With over 20 years of experience in drug discovery within biotech and CRO environments, Gunnar brings a wealth of strategic vision and entrepreneurial expertise to his role. He is dedicated to developing comprehensive short- and long-term strategic plans aimed at optimizing efficiency, fostering growth, and enhancing profitability within Ardena’s Bioanalysis division.
Esther Biemans is a Senior Scientist and Project Manager at Ardena. She brings extensive experience in large molecule analysis and has specialized in developing and validating PK, PD, and ADA assays for a wide range of drug development projects over the past 15 years.
Since moving into the CRO industry in 2010, Esther has worked as a senior scientist and project manager, building extensive expertise in large molecule bioanalysis.
Esther obtained her PhD in Biochemistry from the University of Groningen in 2006, focusing on immunology and enzymology. She subsequently completed postdoctoral research at the University of British Columbia in Vancouver before transitioning into the CRO industry.
Niels Nijstad is a Subject Matter Expert in bioanalysis at Ardena. He supports Sponsors in aligning drug development needs with Ardena’s scientific and operational capabilities.
His work focuses on phase-appropriate bioanalytical strategies for drug development programs, including PK, ADA, and biomarker assays. He brings over 15 years of experience across biotech and CRO environments, with expertise at the intersection of translational bioanalysis, regulatory expectations, and business operations.
Niels obtained his PhD from the University of Groningen, where his research focused on cholesterol transport.
Analytical Sciences
CMC Development
CRO Operations
Paul van Tilborg is a senior scientific and operational leader with over 25 years of experience in analytical sciences, CMC development, and CRO operations. As Director CRO Services at Ardena in Oss, he is responsible for building and scaling bioanalytical capabilities and leading solid-state research activities, while contributing at an executive level to API analytical sciences.
Paul has a strong track record in developing organisations, facilities, and teams with a clear focus on operational efficiency, customer value, and financial performance. At Ardena, he transformed the analytical sciences function from a small start-up operation into a fully established department supporting multiple development programmes, combining technical capability build-up with scalable, financially robust operations. He consistently drives growth by aligning scientific excellence with client needs, ensuring reliable delivery, transparency, and long-term partnerships. His approach emphasises fit-for-purpose solutions, efficient execution, and creating measurable value for customers and the organisation.
Earlier in his career at MSD (Organon/Schering-Plough), he led analytical development teams and contributed to CMC strategies, regulatory submissions, and the delivery of complex drug development programmes.
He holds a PhD in Chemistry from Utrecht University and contributes to postgraduate education through teaching in applied NMR spectroscopy.
Ardena Pamplona
About This Facility
Welcome to Ardena Pamplona
Our Pamplona site specializes in oral solid drug development and manufacturing, with expertise in highly potent compounds up to OEB5 and spray-drying technology to enhance the bioavailability of poorly soluble drugs.
With a growing scientific and operations team of 110+, we focus on niche oncology treatments and orphan drugs — making a real difference for patients who are waiting.
Susana Santesteban is QA Director and QP at Ardena Pamplona. She brings extensive experience in pharmaceutical quality systems, GMP compliance, and quality leadership across pharmaceutical manufacturing environments, including multinational companies and CDMOs.
Since 2008, Susana has held leadership positions in Quality Assurance and has served as Qualified Person across different pharmaceutical organizations. Her expertise includes EU GMP and 21 CFR Part 210/211 compliance, audits, validation activities, continuous improvement projects, and the implementation of new regulatory requirements and digital quality management systems. At Ardena, she supports operational excellence and quality compliance across pharmaceutical development and manufacturing activities.
Susana obtained her Bachelor’s Degree in Pharmacy from the University of Navarra and completed specialized training in Industrial Pharmacy, Quality Management, and Regulatory Affairs.
Irantzu San Martín is Project Management Director at Ardena Pamplona. She is a pharmacist with more than 20 years of experience supporting drug product development and manufacturing within CDMO environments.
At Ardena, Irantzu leads Project Management, Logistics, and Warehouse operations, supporting seamless end-to-end execution of client programs. Her expertise includes coordinating cross-functional teams to deliver integrated solutions aligned with timelines, quality standards, and regulatory requirements, including GMP and FDA expectations. She is recognized for her client-focused approach and for supporting tailored and flexible solutions across pharmaceutical development programs.
Irantzu obtained her pharmacy degree and completed a Master’s degree in Pharmaceutical Industry.
Formulation Production
GMP Manufacturing
Production
Iñaki Bueno is Formulation-Production and Maintenance Director at Ardena Pamplona. He is a pharmacist with more than 30 years of experience in pharmaceutical development, specializing in formulation design, process scale-up, and GMP manufacturing of innovative drug products.
At Ardena, Iñaki leads formulation and production activities, supporting drug product development from pre-formulation through clinical supply and commercial readiness. His expertise includes oral solid dosage forms, pharmaceutical process transfer, Quality by Design (QbD), experimental design (DoE), and solubility enhancement technologies, including spray drying.
Iñaki brings extensive technical and operational experience across pharmaceutical development and manufacturing environments, supporting efficient and compliant drug product development programs.
Beatriz Aranguren is Analytical Services Director at Ardena Pamplona. She brings more than 20 years of experience across analytical services, manufacturing, and continuous improvement within the pharmaceutical, food, automotive, and renewable energy industries.
At Ardena, Beatriz leads the Analytical Services team and oversees operational performance, resource management, and customer service delivery across quality, timelines, and cost objectives. Prior to joining Ardena, she held leadership positions within the food industry, managing large-scale production operations, process optimization, safety, and cost reduction initiatives. Earlier in her career, she worked on Lean Manufacturing and productivity improvement projects for industrial companies, as well as engineering and product development activities within multinational organizations in the renewable energy and home appliance sectors.
Beatriz brings extensive expertise in operational excellence, team leadership, process efficiency, and cross-functional project management across complex industrial and pharmaceutical environments.
Leyre Diez Martínez de Morentin is Packaging Group Leader at Ardena Pamplona. She specializes in secondary packaging and clinical trial supply within GMP-regulated pharmaceutical environments.
Throughout her career, Leyre has developed extensive experience in the design and execution of complex packaging strategies, including double-blind and highly customized clinical trial designs. Her work focuses on supporting packaging operations across demanding clinical development programs while ensuring operational excellence and regulatory compliance.
Leyre is recognized for her ability to solve complex packaging challenges and support efficient execution within dynamic project environments.
Drug Product Development
GMP Manufacturing
Spray Drying
Javier Gurrea specializes in spray drying and drug product development at Ardena Pamplona. He brings around nine years of experience across pharmaceutical development and commercial manufacturing within GMP-regulated environments.
Throughout his career at Ardena, Javier has held different roles supporting pharmaceutical development and manufacturing activities. He has developed strong technical expertise in spray drying, supporting the development, scale-up, and manufacturing of complex drug products across different stages of development.
Javier is a pharmacist by training and obtained his PhD through research conducted at Ardena.
Cleaning Validation
Contamination Control
Technology Transfer
Carolina Cebrian specializes in Cleaning Verification Strategy at Ardena Pamplona. She brings extensive experience across pharmaceutical project management, manufacturing coordination, technology transfer, and contamination control within GMP-regulated environments.
Since joining Ardena Pamplona in 2015, Carolina has worked across several functions, including Project Management, Customer Relationship Management, Manufacturing Coordination, and Technology Transfer. Her expertise focuses on Cleaning Validation, Cross-Contamination Strategy, and Molecule Categorization, with strong experience in risk assessment and contamination control within pharmaceutical manufacturing environments. More recently, she expanded her expertise through involvement in pharmaceutical quality systems within the QA area.
Carolina has a background in Biochemistry and obtained her PhD in Neurosciences and Neuroimmunology. She also completed seven years of postdoctoral research at Columbia University in the United States.
Clinical Manufacturing
Oral Solid Dosage Forms
Process Optimization
Almudena Dominguez is Formulation Development and Clinical Production Group Leader at Ardena Pamplona. She brings more than 11 years of experience in drug development and manufacturing within GMP-compliant pharmaceutical environments.
Her expertise focuses on oral solid dosage forms, including tablets, capsules, and granulates, across both early-stage clinical development and late-stage development programs. Throughout her career, Almudena has developed extensive experience in QbD-driven development, process optimization, scale-up, and process validation activities supporting pharmaceutical manufacturing and development programs.
Almudena has a background in Chemistry and obtained a Master’s degree in Drug Development.
Analytical Operations
GMP Compliance
Quality Control
Marta Irurzun specializes in Analytical GMP Compliance at Ardena Pamplona. She brings extensive experience in quality control, analytical operations, and GMP-regulated pharmaceutical environments, with a strong focus on process-oriented quality and regulatory compliance.
Marta began her career in the pharmaceutical industry at CINFA before joining IDIFARMA during an early stage of the company’s development, where she led the setup of the Quality Control department. In this environment, she worked closely with development teams across multiple activities, contributing to the organization’s operational growth. Following the integration into Ardena, she continued to expand her expertise within GMP analytical environments, focusing on adapting operations to regulatory requirements and supporting client audit readiness.
Her experience combines analytical expertise with a broad operational perspective across pharmaceutical development and GMP compliance activities.
Ardena Ghent
About This Facility
Welcome to Ardena Ghent
Our headquarters and a hub for drug product development and manufacturing, Ardena Ghent is home to 110+ employees. This site also houses our CMC Regulatory team, providing specialist expertise and tailored services to support customers from pre-clinical to clinical manufacturing.
With a focus on injectable and oral drugs — particularly those with low solubility challenges — our site in Ghent is a center of excellence for drug products, clinical logistics, and CMC regulatory services.
Wannes Deckers is Associate Director of Quality and serves as a Qualified Person (QP) at Ardena. He brings extensive experience in pharmaceutical quality assurance and investigational medicinal product manufacturing within GMP-regulated environments.
Wannes began his career through a Trainee Qualified Person program at MSD, where he built a strong foundation in cGMP compliance. Throughout his career, he has held multiple quality and pharmaceutical leadership roles, including Industrial Pharmacist and QP at Air Liquide Medical, as well as Responsible Person (GDP) for VitalAire NL. Prior to joining Ardena, he worked as a Project Engineer and consultant at Pfizer, supporting Pre-Approval Inspections (PAI) for analytical operations across several biosimilar programs. At Ardena, he focuses on phase-appropriate GMP manufacturing and successfully led the implementation of the company’s aseptic manufacturing facility, including cleanroom and isolator qualifications and aseptic manufacturing processes. He currently combines QP responsibilities with broader quality leadership activities across pharmaceutical operations.
Wannes obtained his Master in Drug Development and his degree in Industrial Pharmacy from Ghent University.
Anke Moret is Director CMC Regulatory at Ardena, based in Ghent, Belgium. She brings more than two decades of experience in regulatory affairs, with expertise spanning CMC regulatory strategy, operational management, and regulatory project leadership.
Anke first joined Ardena, then known as HEA, in 2001 as Regulatory Affairs Assistant. After leaving the organisation in 2005, she returned in 2009 as Regulatory Affairs Officer and progressed through several key roles, including Senior Regulatory Affairs Officer and Regulatory Project Manager. Since 2021, she has co-led the CMC Regulatory Business Unit together with Julie De Smet, with primary responsibility for operational management and delivery excellence within the unit.
Anke holds a Master’s degree obtained in 2000 and has built extensive expertise in regulatory operations and project management throughout her career in the pharmaceutical industry. In her current role, she works in close partnership with Julie to ensure efficient execution of regulatory projects and to drive continuous improvement across the team.
Annelies Paridaens is Director of Project Management at Ardena Ghent. She brings extensive experience in clinical supply and a strong track record in managing complex pharmaceutical development programs.
At Ardena, Annelies focuses on ensuring efficient project execution, aligning stakeholder expectations, and maintaining high quality standards across development activities. She is known for her structured approach, pragmatic leadership style, and clear communication, as well as her ability to navigate complex technical and regulatory challenges. She works closely with internal stakeholders and international clients, translating technical requirements into clear project strategies and fostering collaborative partnerships.
Annelies is committed to supporting the efficient advancement of innovative therapies and contributing to Ardena’s mission of accelerating the path from molecule to medicine.
Formulation Development
GMP Manufacturing
Quality Assurance
Daan Vanhaecke is Group Leader for Formulation Development and Production at Ardena. As an industrial pharmacist, he combines hands-on technical expertise with a structured and quality-driven approach across GMP manufacturing and pharmaceutical development environments.
Prior to joining Ardena, Daan built experience across several pharmaceutical companies, contributing to equipment qualification for ATMP manufacturing and Quality Assurance oversight activities. At Ardena, he is responsible for the day-to-day management of GMP production projects and associate scientists, including troubleshooting technical and GMP compliance challenges to ensure projects are delivered on time, within budget, and in compliance with cGMP standards.
Daan brings experience across both QA and manufacturing environments and works closely with internal stakeholders and clients to support the successful development and production of innovative therapies.
CMC Writing
Dossier Development
Regulatory Affairs
Julie De Smet is Director CMC Regulatory at Ardena, based in Ghent, Belgium. She brings extensive expertise in CMC writing, dossier development, and regulatory strategy, supporting pharmaceutical development programmes from early phase through commercial.
Julie joined Ardena, then known as Pharmavize, in 2012 as Regulatory Affairs Officer and advanced through several leadership positions, including Regulatory Affairs Project Manager, Subject Matter Expert in CMC writing, and Associate Director of Dossier Development. Since 2021, she has co-led the CMC Regulatory Business Unit together with Anke Moret, with a strong focus on scientific content, dossier quality, and regulatory strategy.
Julie obtained her Master’s degree in Pharmaceutical Sciences from Ghent University in 2006 and completed her PhD in 2012, specialising in analytical method development to support pharmacokinetic studies. In her current role, she collaborates closely with Anke to ensure high-quality regulatory deliverables and to strengthen the integration of scientific expertise and regulatory requirements across projects.
Formulation Development
Process Optimisation
Solid Dosage Development
Laure Descamps is Senior Formulation Scientist at Ardena, specializing in solid dosage development and process understanding. She supports formulation design, process optimisation, and early-phase drug product development for complex pharmaceutical programs.
At Ardena, Laure applies her expertise to developing robust formulation strategies that support the efficient advancement of complex molecules toward clinical evaluation. Her work focuses on formulation development and process understanding across early-stage drug product development activities.
Laure obtained her Master’s degree in Drug Development and Industrial Pharmacy and earned her PhD from Ghent University’s Laboratory of Pharmaceutical Process Analytical Technology. Her doctoral research focused on tabletting behaviour, material characterisation, and compression challenges in collaboration with industry partners.
Dr. Raja Yekkala is Business Development Director at Ardena. He brings more than 20 years of experience across pharmaceutical sciences, CMC development, analytical sciences, drug product development, clinical supply, and manufacturing support.
At Ardena, Raja focuses on strategic business development for integrated pharmaceutical development and manufacturing programs in both human and veterinary applications. He supports clients throughout the full development journey, from early-stage activities through clinical phases, working closely with multidisciplinary teams across formulation development, analytical development, GMP manufacturing, regulatory affairs, project management, and clinical supply. His expertise includes comparator sourcing strategies, clinical trial supply planning, and the coordination of complex clinical supply programs supporting global development activities. Over the course of his career, he has contributed to bringing several dozen compounds into clinical development. Prior to transitioning into business development leadership roles, Raja held scientific and project management positions at Ardena and Pharmavize, where he managed complex CMC programs, clinical supply manufacturing activities, and cross-functional development projects. Earlier in his career, he worked as a research scientist at KU Leuven, contributing to pharmaceutical analysis, method development, and pharmacopoeial monographs adopted by the WHO.
Raja is a pharmacist by training and obtained his PhD in Pharmaceutical Chemistry and Drug Analysis from KU Leuven, Belgium. He is author and co-author of multiple peer-reviewed scientific publications, contributor to internationally recognized pharmacopoeial monographs, and co-inventor of a patent related to pharmaceutical formulation technologies.
Analytical Development
Chromatography
GMP Analytics
Sander Delahaye is Group Leader in Analytical Chemistry at Ardena Ghent. He brings extensive expertise in analytical method development, validation, and lifecycle management within GMP-regulated pharmaceutical environments, with a strong focus on chromatographic techniques and physicochemical analysis.
Prior to joining Ardena, Sander worked at Ajinomoto OmniChem as Group Leader in Analytical Development, supporting the development and commercial manufacture of active pharmaceutical ingredients (APIs). During this time, he built extensive expertise in analytical method development and validation in accordance with ICH guidelines, with technical experience spanning GC, HPLC/UHPLC, and orthogonal analytical techniques, including Karl Fischer titrations. He also played a key role in GMP release testing, as well as the validation and troubleshooting of analytical methods for large-scale synthetic processes. After a decade focused on API analytical development, he transitioned to Ardena to broaden his expertise toward drug product development, supporting formulation development, release testing, and stability studies for clinical trial materials.
Sander obtained his Master’s degree in Chemistry from Ghent University, followed by a PhD specializing in separation sciences. His doctoral research focused on the fundamental principles of supercritical fluid chromatography (SFC) and contributed to the understanding and optimization of this technique for complex analytical applications.
Formulation Development
GMP Manufacturing
Oral and Parenteral Formulations
Dr. Timothy Pas is Associate Director, Formulation Development and Production at Ardena. He leads a team supporting formulation development and GMP manufacturing activities for early clinical programs.
Since joining Ardena, Timothy has progressed from Formulation Scientist to Group Leader and currently Associate Director. Throughout his career at Ardena, he has developed extensive expertise in oral and parenteral formulations, formulation development strategies, and GMP manufacturing operations supporting early-stage pharmaceutical development programs.
Timothy obtained a Master’s degree in Drug Development and earned his PhD in Pharmaceutical Technology from KU Leuven, specializing in enabling technologies and galenic principles.
HR Business Partnership
Human Resources
Organizational Transformation
Vicky De Paepe is an HR Manager with experience across industrial and biotech environments. She brings extensive expertise in HR business partnering, organizational transformation, and people management within complex and evolving organizations.
Vicky started her career in an all-round HR role within the automotive sector in Antwerp before joining Ablynx as HR Officer. Over the years, she progressed into senior HR roles and ultimately became HR Manager. Following the acquisition of Ablynx by Sanofi in 2018, she transitioned into the role of HR Business Partner for the Ghent R&D site, supporting the organization through significant transformation initiatives, including multiple reorganizations and a collective dismissal process in 2024. After this transformation period, she joined Ardena for a new professional challenge.
Her experience combines operational HR expertise with a strong focus on organizational change, stakeholder support, and people-focused leadership within dynamic business environments.
Juan Jose Serrano
Your molecule deserves the right expert.
Our scientists have spent careers solving the formulation problems that stop other CDMOs. Let's talk about yours.