Nanobody-drug conjugates (NDCs) are gaining momentum as next-generation targeted therapies, offering improved tissue penetration and faster clearance compared to traditional antibodies. These novel biologics demand a unique combination of biologics, chemistry, and conjugation expertise — making specialized NDC CDMO companies essential partners in their development.
As an evolution of ADCs, NDCs present specific formulation, scalability, and regulatory challenges. Collaborating with experts in nanobody-drug conjugate contract manufacturing ensures the necessary infrastructure, compliance, and technical know-how are in place to move from discovery through clinical and commercial production.
How to Choose NDC CDMO Companies
When selecting among NDC CDMO companies, it’s crucial to consider partners with experience in both biologics and HPAPIs, and who understand the specific demands of nanobody-based platforms. Key criteria include:
- Nanobody engineering expertise: Including single-domain antibody expression systems.
- Site-specific and stochastic conjugation capabilities.
- Experience with linker-payload strategies: Tailored to smaller scaffold proteins.
- HPAPI containment and GMP conjugation: Infrastructure for safe handling.
- Custom analytics: For DAR, aggregation, and nanobody integrity.
- Regulatory familiarity: With first-in-class and orphan nanobody therapeutics.
Not all ADC CDMOs are equipped for nanobody platforms — choosing one that is ensures a better technical and regulatory fit.
Key Services Offered by Nanobody-drug Conjugate Contract Manufacturers
Nanobody-drug conjugate contract manufacturing typically includes:
- Nanobody production: Via microbial (E. coli, yeast) or mammalian expression systems.
- Payload synthesis: And linker optimization for low molecular weight targets.
- Conjugation development and scale-up: Under GMP conditions.
- Analytical testing: DAR, SDS-PAGE, SEC, HPLC, and bioactivity assays.
- Formulation and fill-finish: For parenteral delivery.
- Stability studies and cold chain packaging.
- CMC support: For IND and CTA submissions.
These tailored services ensure safety, precision, and manufacturability across nanobody-based therapeutics.
Advantages of Partnering with NDC CDMO Companies
Engaging specialized NDC CDMO companies provides distinct advantages:
- Smaller-scale process optimization: Ideal for early-stage and orphan drugs.
- Improved targeting: Of solid tumors and difficult-to-access tissues via nanobodies.
- Integrated platforms: That combine biologics, chemistry, and GMP fill-finish.
- Faster development timelines: With access to existing nanobody production know-how.
- Compliance with biologics and HPAPI standards: For global submissions.
These CDMOs understand the structural and regulatory nuances of nanobody-drug conjugates and can adapt processes accordingly.
NDC CDMO Companies
Some of the leading NDC CDMO companies with emerging or established capabilities include:
- 53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing services from preclinical to cGMP manufacturing. [See CDMO profile]
- Shilpa Biologicals: CDMO supporting process development, from gene to cell line development to GMP, formulation development, analytical development, drug substance, drug product, fill-finish, and packaging. [See CDMO profile]
- Cultiply: Spanish CDMO developing production and purification processes for recombinant proteins, enzymes, DNA, and other bioderived products. [See CDMO profile]
- SINOWAY INDUSTRIAL CO: One-stop CDMO solutions for Abs (antibodies), ADC & NDC (antibody-drug) manufacturing, API and key intermediates. [See CDMO profile]
- CARBOGEN AMCIS: Development and cGMP manufacturing of highly potent APIs, including antibody-drug conjugates (ADC). [See CDMO profile]
- Mabion: Fully integrated CDMO offering a wide range of services for the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and other recombinant protein-based products. [See CDMO profile]
Related Information
Let MAI CDMO Network Help You Find the Right NDC CDMO Partner
At MAI CDMO Network, we specialize in connecting you with the most capable NDC CDMO companies to develop and manufacture your nanobody-drug conjugate efficiently and compliantly. From early-phase development to commercial production, our network of nanobody-drug conjugate contract manufacturing partners is ready to accelerate your program.
Let’s find your perfect fit. Contact us today to discover NDC CDMOs aligned with your molecule, modality, and timeline.
