Beyond GMP: Selecting and Managing CDMOs for Biological Products
Join our experts, and by attending this forum, you will:
- Recognise CDMO selection as a structured project: understand why treating it as a managed process, rather than a one-off procurement decision, leads to better partnerships and fewer costly surprises.
- Apply project management thinking to due diligence: identify the PM signals that reveal a CDMO’s true operational maturity, including scope clarity, risk awareness, and escalation practices.
- Look beyond GMP compliance: articulate why regulatory compliance is an entry criterion, not a differentiator, and identify the three failure modes that standard audits consistently miss for biological products.
- Evaluate and select CDMOs using a multi-dimensional framework: assess scientific fit, operational reliability, financial stability, and partnership culture, and match selection criteria to your development phase and risk profile.
Event overview
GMP compliance is the starting point for any CDMO shortlist. Yet for many biotech and biopharma companies, it remains the primary lens through which manufacturing partners are evaluated. This forum challenges that assumption and offers a more rigorous, experience-driven approach to CDMO selection and management.
The first presentation explores how structured project management thinking directly shapes the quality of CDMO relationships. From scoping and risk mapping to milestone ownership and performance accountability, it reveals what sponsors can do differently at every stage of the engagement to avoid costly misalignments that derail programmes.
The second presentation makes the case that biological products carry inherent risks that standard compliance audits are simply not designed to surface. Technology mismatches, operational fragility, and failures in partnership culture have led to the closure of programmes operating in fully GMP-certified facilities. Attendees will leave with a practical, multi-dimensional scoring framework for evaluating CDMOs across the dimensions that actually predict success.
Together, these sessions offer a candid, expert-led perspective on what it takes to select well, manage effectively, and build CDMO partnerships that hold up under pressure.
What you need to know:
Dual-time broadcast, with starting times as follows:
Wednesday, 16 September 2026
- Broadcast #1 (Europe/Asia): 10:00 h BST (London) / 11:00 h CEST (Paris/Berlin) / 14:30 h IST (New Delhi) / 17:00 h SGT (Singapore) / 18:00 h JST (Tokyo)
- Broadcast #2 (North America / Europe): 08:00 h PDT (Los Angeles) / 11:00 h EDT (New York) / 16:00 h BST (London) / 17:00 h CEST (Paris/Berlin)
Duration: Approximately 60 – 90 minutes, incl. Q&A.
Who should attend?
Anyone involved in selecting, managing, or working alongside CDMOs will find this forum directly relevant, including:
- Biotech/biopharma project managers and programme leads
- CMC and technical operations leads
- Quality and compliance managers
- Founders and C-suite of small and emerging biotechs
- Business development and alliance managers at CDMOs
Marta Kijanka, PhDManaging Director and Principal ConsultantMK 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 KoopmansGMP/QA ConsultantAMK 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.
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Dr. Ewoud van TrichtScientific DirectorBioQCExpert 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 GriendScientific DirectorBioQCExpert 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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