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Top 6 qualities to look for in a CDMO partner for ADCs


Novasep Top6qualities

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.

 

Looking for an experienced CDMO partner for your ADCs?
Contact us

 

*Data from Roots Analysis - ADC Contract Manufacturing (CMO) Market report

 

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