Aad van de Leur is a highly experienced biotech professional with over 40 years of expertise in CMC development, biotechnological process development, and GMP manufacturing. He has in-depth knowledge of cell culture, downstream processing, purification, analytical development, validation, and the associated quality and regulatory aspects. Aad combines strong technical expertise with operational and strategic leadership in both clinical and commercial environments.

From 2013 to early 2025, Aad served as Chief Operating Officer (COO) at Byondis (formerly Synthon Biopharmaceuticals) in Nijmegen. In this role, he was responsible for all biopharmaceutical operational activities, including process development from cell line to drug product, manufacturing and supply of IMPs and future commercial material, with a strong focus on monoclonal antibodies (mAbs) and Antibody Drug Conjugates (ADCs).

Since July 2025, Aad has been active as an independent consultant, leveraging his broad CMC and operational experience to support biotech and biopharma organizations.

Expertise and Services

• CMC development within biotech and biopharmaceuticals
• Biotechnological process development and validation
• Manufacturing and technology transfer (clinical and commercial)
• Cell culture and downstream processing
• Quality and regulatory aspects within CMC programs
• Operational and strategic management

Positions

• Chief of Staff – Batavia Biosciences (2025 – present)
• COO – Byondis (2013–2025)
• Vice President / Director Biopharmaceutical Development – Synthon (2009–2012)
• Senior Director Customer Project Management – Organon (2003–2008)
• Director / Assistant Director Downstream Processing R&D – Diosynth (1993–2003)
• Laboratory Technician – Diosynth & Organon (1985–1993)

Professional Experience (selection)

Since July 2025, Aad has been working as Chief of Staff at Batavia Biosciences, where he supports the CEO on organizational matters, the development of viral vector vaccines, and the qualification of a new large-scale production facility. Prior to joining Batavia, he worked at Byondis (formerly Synthon Biopharmaceuticals) from January 2009 onward, initially in senior development and management roles and from 2013 as COO. He led end-to-end biopharmaceutical CMC activities, from early process development to clinical and commercial manufacturing and supply.

Before that, Aad spent more than 23 years in various biotech departments at Diosynth and Organon/Schering-Plough. He started in cell culture development, where he was involved in the development, optimization, and troubleshooting of cell culture processes using, among others, hollow fiber bioreactors, cell factories, (fed-)batch fermentation, and perfusion systems up to a scale of 100 liters.

He subsequently spent more than 10 years responsible for purification process development, optimization, viral clearance studies, troubleshooting, production of glycosylated proteins, and cleaning validation. In his final phase at Organon, Aad led complex technology transfer projects for approximately five years, including cell culture, purification, and analytical transfers for both internal projects and external partners.

Throughout his career, Aad has been involved in multiple regulatory filings and interactions with EMA, FDA, and Japanese authorities.

Education

• MSc Chemistry – Utrecht University
• Ing. HNWO – Dr. Struycken Institute

Skills

CMC development • Biotech process development • Manufacturing & tech transfer • Cell culture • Downstream processing • Purification • Quality & regulatory oversight • Operations management

LinkedIn

https://www.linkedin.com/in/aad-van-de-leur-4728307/

Marc Kamp is a highly experienced Senior Quality Assurance Manager and Director with a strong track record within the (bio)pharmaceutical industry. He has in-depth expertise in Quality Assurance, Quality Engineering, CMC, manufacturing and supply chain processes for biologicals, ATMPs and cell therapies, in both clinical and commercial environments.

Marc primarily supports small and medium-sized organizations with complex EU and US GxP compliance challenges, improvement programs and new plant start-ups, including initial GMP licensing and commercial launches.

Currently, Marc is Director Quality Engineering and Program Lead GxP Quality Cell Therapy at Kite Pharma, where he is responsible for quality strategy, GxP compliance and quality assurance for commercial cell therapy activities in the Netherlands. In this role, he leads the Quality Engineering function for the manufacturing site, with responsibility for technology transfer, automation, cleanroom and equipment qualification, process and analytical validation, and the Quality Risk Management program.

Expertise and services

• Quality Assurance and GxP compliance (EU/US)
• Quality Engineering and quality strategy
• ATMPs, biologicals and cell therapy (clinical and commercial)
• New plant start-ups, GMP and Tissue Establishment (TE) licensing
• Technology transfer, validation and qualification
• Supplier Quality Management and distribution networks
• Total Quality Management within clinical and commercial supply chains
• QA organization and team management (5–15 FTE)

Positions

• Director / Senior Director Quality & Quality Engineering – Kite Pharma (2017–present)
• Executive Director Quality – Neogene Therapeutics
• Director Quality Assurance – uniQure
• Director / Senior Manager QA – SynCo Bio Partners & Kiadis Pharma
• Associate Director QA Regulatory Compliance – TEVA Pharmachemie
• QA management roles – Crucell and Biogen Idec

Professional experience (selection)

At Kite Pharma, Marc was responsible for the initial start-up of the Dutch manufacturing site, including GMP and Tissue Establishment licensing, the implementation of quality systems, QP batch release processes and ATMP-specific OOS processes. He supported the commercialization of cell therapies in Europe and beyond, including 23 international launches and the associated distribution networks.

Previously, Marc worked with several ATMP organizations on the set-up and qualification of clinical supply chains for EU and non-EU patients, with manufacturing sites in, among others, Germany and Canada. He started his career in traditional biotech (monoclonal antibody manufacturing) and subsequently developed his expertise in clinical and commercial labeling and packaging, generic pharmaceutical manufacturing, and leading quality departments within biotech CMOs (drug substance and drug product).

Throughout his career, Marc has maintained intensive interactions with regulatory authorities (including submissions and responses to questions) and has extensive experience in hosting and supporting inspections by, among others, EMA, FDA, Anvisa and local authorities.

Education

• PGDip in Pharmaceutical Quality & GMP – University of Strathclyde
• BSc in Biotechnology – HAN University of Applied Sciences

Skills

Quality Assurance • Quality Engineering • GxP compliance • ATMP & cell therapy • Supplier quality • QA leadership • New plant start-up • Validation & qualification • Strategic quality management

LinkedIn

https://www.linkedin.com/in/mgkamp/