The development and manufacturing of Antibody-Drug Conjugates is complex and requires both biological and chemical know-how. To meet these challenges, pharma companies today outsource 70% to 80% of their ADC manufacturing operations*. But how to select the right CDMO that can meet your outsourcing needs?
Here are the top 6 qualities to look for when selecting a CDMO partner for ADCs:
1 - Recognized technical expertise
Identify a CDMO with a successful track record in process development and cGMP manufacturing of ADCs:
- Bioconjugation
- Payload-linker
- HPAPI handling
- Purification
2 - Robust analytical skills
Look for state-of-the-art analytical equipment and an experienced team for bioconjugation and payloads:
- Characterization
- Stability
- Identity
- Purity
- Potency
- Safety
3 - Integrated ADC solutions
Simplify your ADC supply chain by selecting a CDMO capable of offering several key components:
- mAb preparation
- Linker preparation
- Payload preparation
- Conjugation
- ADC DP release testing
4 - Long-term partner
Choose a CDMO with capabilities to support you from early development to commercial launch:
- Lab samples
- Tox batches
- cGMP clinical batches
- Validation batches
- cGMP commercial batches
5 - Flexible and collaborative approach
Make sure your CDMO partner has a strong project management culture and is flexible to support the changing needs of your project:
- Timeline
- Deliverables
- Quality
- Service
6 - Strong regulatory track record
Select a CDMO demonstrating an outstanding regulatory history with experience at validation and commercial launch.
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*Data from Roots Analysis - ADC Contract Manufacturing (CMO) Market report
