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Nanobody CDMO Services
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About Nanobody
Nanobody (Nb), i.e. variable domain of heavy chain of heavy-chain antibody, was first reported by Belgian scientists in the journal Nature in 1993. It is a single-domain antibody composed of a variable region (VHH) of natural heavy chain antibody that lacks a light chain in camelides (camel, llama, alpaca and their close relative species). The antibody contains only one heavy chain variable region (VHH) and two conventional CH2 and CH3 regions. The VHH crystal is a cylinder with a diameter of 2.5 nm and a length of 4 nm. The molecular weight is only 15 kDa, so it is also called a nanobody (Nanobody, Nb).
Photo source: International Journal of Nanomedicine 2016:11 3287-3303
Nanobody CDMO Service Overview
The comprehensive nanobody one-stop technology platform and CDMO integrated solutions of Yaohaibio can provide customers with whole life cycle services including gene engineering strain construction, strain bank establishment, laboratory process development/optimization, pilot process scale-up, IND application and clinical sample preparation, quality specification establishment, analytical method development/validation, quality management system establishment, NDA registration and application and commercial production (MAH). The production platforms support different production scale, from laboratory, pilot scale to large-scale, with a series of services such as process and method development and validation, equipment qualification and quality control, and quality research, to cooperate with customers from early drug discovery to clinical research and large-scale commercial marketing.
Nanobody Expression Carrier
Escherichia coli
Yeast expression
Nanobody CDMO service covers the entire product development cycle
Plasmid Construction
Gene synthesis
Carrier construction
Strains and Strain Bank Establishment
Primary strain
Primary strain bank establishment
Secondary strain bank establishment
Process Development
Fermentation process development
Purification process development
Drug product process development
Stability Study
Quality specification establishment
Analytical method development
Analytical method transfer and validation
IND/GMP Sample Production
7-2001L fermentation production
Downstream purification process
Sterile drug product filling
Product Release
Improve the quality control system
Improve the quality assurance system
Meet the requirements of laws and regulations
Registration and Application
IND application
NDA application
International application (FDA, EMA)
Registration consultation
MAH
Commercial production
Platform Advantages
Case example
Target

Purity ≥ 95%; endotoxin <50 EU/mg of protein.


The two-step chromatography method was developed.

Affinity chromatography: after affinity with A3, purity reached 94.1%

Anion exchange chromatography: after the use of 50HQ, yield reached 73.9% and purity reached 98.1%


Meets process target after endotoxin test.

Focus on
microbial expression system
CDMO service leader

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