Beyond GMP: Selecting and Managing CDMOs for Biological Products

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Presenters / Panellists

Marta Kijanka Managing Director and Principal Consultant MK Bio Consultancy (The Netherlands) Marta Kijanka is a life sciences consultant with a uniquely well-rounded perspective on drug development partnerships, shaped by hands-on experience on all sides of the service-sponsor relationship - having worked within a CRO, a biotech start-up, and a CDMO. This breadth gives her rare insight into how each party thinks, prioritises, and communicates, and what it takes to make collaborations truly work. Marta holds a PhD from Utrecht University, a PMP certification from PM, and a Value Stream Mapping certification. Through MK Bio Consultancy, she helps biotech companies make smarter, risk-aware decisions when selecting and managing their CDMOs.

Anna-Myra Koopmans GMP/QA Consultant AMK Compliance Insight (The Netherlands) Anna-Myra is a Pharmacist and QP, a Quality leader with 30+ years’ experience (including 10+ years as QP) managing Quality teams in commercial and IMP environments across both big pharma and the CDMO field. She is an expert in sterile manufacturing, GMP compliance, and Quality systems, and works with companies on Permanent Inspection Readiness. Additionally, she provides GMP training to QPs and SMEs and conducts audits. With a strong client-oriented approach, she strives to build trust, exceed expectations, and create lasting value for both internal and external stakeholders.

Moderators

Dr. Ewoud van Tricht Scientific Director BioQC Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.

Prof. Dr. Cari Sänger-van de Griend Scientific Director BioQC Expert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.

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