🌍 Day 3｜6 Key Concerns Global Biotech Companies Have When Selecting a Chinese Oligonucleotide CDMO

🌍 Day 3｜6 Key Concerns Global Biotech Companies Have When Selecting a Chinese Oligonucleotide CDMO
When overseas biotech teams evaluate a Chinese CDMO, their first questions are not about cost.
Instead, they ask:
❗ Can I safely trust them with my sequence, process, and IP?
❗ Do they truly have the ability to deliver clinical-grade oligonucleotides?
In oligonucleotide development (siRNA, ASO, mRNA, sgRNA, AOC, POC), CDMO selection is really about:
Technology × Quality × Compliance × Risk Control
🔹 6 Core Evaluation Criteria
1️⃣ Quality & Regulatory Compliance 🔑
➡ Can the product be used for IND/CMC submission?
1. Do you have GMP / ICH Q7 certifications?
2. Clinical-grade / commercial-grade capability?
3. IND / EMA / FDA documentation support?
4. Batch Record, QC data, impurity profiling?
5. Proven submission experience?
2️⃣ IP Protection & Confidentiality 🔐
➡ Can we safely share sensitive sequences?
1. NDA / Quality Agreement before disclosure?
2. Encrypted and access-controlled data?
3. No internal reuse or storage of sequences?
4. Secure transfer protocols?
3️⃣ Technical Communication & Project Management 📞
➡ Can you explain data—not just send reports?
1. English-speaking technical team?
2. Dedicated PM / weekly calls?
3. Change control and milestone tracking?
4. Ability to interpret QC results?
4️⃣ Lead Time & Manufacturing Capacity ⏱
➡ Speed, flexibility, scalability
1. Lead time for Research / GMP / IND?
2. Scale: μmol, g, 100g, kg?
3. High-throughput / parallel synthesis?
4. Accelerated / express routes?
5. Stability & degradation data?
5️⃣ Pricing Transparency 💰
➡ More than low cost — clarity & predictability
1. RFQ / BOM / milestone pricing?
2. R&D → IND → Commercial price changes?
3. Hidden fees (validation, documents)?
4. MOQ (Minimum Order Quantity)?
6️⃣ Credibility & Proven Experience 🤝
➡ Is this a reliable long-term partner?
1. IND / EMA / FDA submission history?
2. Virtual facility tour / remote audit?
3. Reference clients or case studies?
4. Collaboration with major biotech/pharma?
🔚 Final Thought
Global partners are not just looking for🏭 a factory that makes oligonucleotides —They are looking for🤝 a trusted partner that delivers quality, transparency, compliance, and communication.

These points are not meant to highlight any shortcomings of Chinese CDMOs.
In fact, many China-based CDMOs have already demonstrated strong capabilities in quality, compliance, and regulatory readiness.

📣 If you have additional concerns or real questions about evaluating Chinese oligo CDMOs, I’d love to hear them.
Your insights will help me improve future content and make it more useful for others.