Home / NDC CDMO Companies | Nanobody-drug Conjugate Contract Manufacturing Services /
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.
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
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.
Nanobody-drug conjugate contract manufacturing typically includes:
Nanobody production via microbial (E. coli, yeast) or mammalian expression
Payload synthesis and linker optimization for low MW targets
Conjugation development and scale-up under GMP
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.
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.
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 from preclinical to cGMP manufacturing. [See CDMO porfile]
Shilpa Biologicals: CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, Fill-Finish and Packaging. [See CDMO profile]
ADC CDMO Companies | Antibody-drug Conjugate Contract Manufacturing Services
Abs CDMO Companies | Antibodies Contract Manufacturing Services
mAb CDMO Companies | Monoclonal Antibodies Contract Manufacturing Services
Biologics CDMO Companies | Biopharmaceutical Contract Manufacturing
At MAI CDMO, 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.
If you have any questions or suggestions, click here. We will be happy to assist you.