Hibreniguss (Hibre) Terefe

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.

Wannes Deckers

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.

Seppe De Smet

Seppe De Smet is Director of Analytical Development. He leads the definition and execution of analytical strategies supporting drug product development across the full product lifecycle at Ardena. He focuses on aligning scientific, regulatory, and client needs through phase-appropriate analytical approaches, control strategies, and lifecycle management.

Throughout his career, Seppe has supported programs from preclinical development through clinical stages and commercialization, providing end-to-end analytical oversight tailored to each phase of development. He has worked across both CRO and biotech environments, combining project leadership with scientific expertise in small molecules and biologics. His experience includes method development, validation, GMP-compliant analytical operations, regulatory submissions, and CMC-related processes including manufacturing, quality control, and release testing.

Seppe earned his PhD in Analytical Chemistry with a strong focus on chromatography. At Ardena, he supports clients through high-quality and pragmatic analytical solutions designed to accelerate development timelines while ensuring product quality and regulatory compliance.

Esther Biemans

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.

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

Employees

200+ team members

Certifications

FDA registered DEA licensed cGMP compliant

Services

Bioanalysis Drug Product Hot Melt Extrusion

Ian Bilodeau

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.

Ariane De Ganck, PhD

Since 2019, Ariane has overseen Ardena’s drug product activities, spearheading successful integration and transformation at Ardena Pamplona and expanding the company’s capabilities to include sterile services.

With over a decade of senior management experience in CRO/CDMO sectors, Ariane excels in leading multidisciplinary teams and is dedicated to team development, fostering networks, and maintaining a customer-centric approach. Her leadership has also been instrumental in driving business development initiatives.

Prior to joining Ardena, Ariane made significant contributions to the growth of Biogazelle, a specialized CRO in RNA and DNA biomarker services.

Ariane holds a PhD in biomedical sciences, focusing on proteins and oncology

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.

Facility Details

Address

Calle Noáin, 1 31110 Noáin, Spain +34 948 214 023

Employees

100+ team members

Certifications

GMP certified (AEMPS) HPAPI handling certified

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.

Facility Details

Address

Kleimoer 4 9030 Ghent, Belgium +32 9 267 65 00

Employees

110+ team members

Certifications

GMP certified GDP certified FAMHP authorized