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Carrier Protein, Recombinant

Carrier Protein, Recombinant

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Modality

Recombinant Carrier Protein

Conjugating the target antigen with a carrier protein is a strategy used in vaccine development. There are currently marketed products known as conjugate vaccines and polysaccharide conjugate vaccines. The carrier proteins approved for use are primarily derived from pathogenic microorganisms, considering production yield and safety. Scientists are attempting to utilize DNA recombinant technology to create carrier proteins. This includes non-toxic mutant CRM197 of diphtheria toxin, tetanus toxin (TT), and Neisseria meningitidis P64k protein. Additionally, novel virus-like particle (VLP) carrier vaccines are also being developed.

Yaohai Bio-Pharma offers a comprehensive recombinant protein service platform that provides customers with a one-stop solution. This includes strain development and GMP production of recombinant carrier proteins. We can deliver carrier proteins ranging from multigram to tens of gram scale, meeting quality specifications. We also provide relevant records and reports tailored to the specific needs of our customers.

Types

Carrier Proteins

Types of Strain

Production Platform

Recombinant Protein

VLP carrier

• Escherichia coli

• Yeast

• Other prokaryotic or eukaryotic microorganisms

•  Microbial fermentation system

•  Centrifugation and homogenization equipment

•  High/low-pressure chromatography system

•  Conjugation reaction vessel

•  GMP quality system

Non-toxic mutant CRM197 of diphtheria toxin

Tetanus toxin (TT)

Neisseria meningitidis P64k protein

Pseudomonas aeruginosa exotoxin A (EPA)

Other recombinant carrier proteins

Yaohai Bio-Pharma is equipped with BSL-2 bio-safety level workshops and provides carrier protein solutions based on pathogenic bacteria. For more information, please refer to the "Non-Recombinant Carrier Protein CDMO Solutions".

One-stop Solution for Recombinant Carrier Proteins
Deliverables

Grade

Deliverables

Specifications

Sample Applications

Non-GMP

Intermediate substance

0.2~10 g (carrier proteins)

Preclinical studies,

 Analytical method development,

Pre-stability studies,

Formulation development

Drug substance

0.2~10 g (conjugated proteins)

Drug product

GMP, Sterile

Intermediate substance

2~100 g (carrier protein)

Investigational new drug (IND),

Clinical trial authorisation (CTA),

Clinical trial supply,

Commercial supply

Drug substance

2~100 g (conjugated proteins)

Drug Product

20,000 vials (liquid or lyophilized), pre-filled syringes or cartridges

Case Study: Recombinant VLP Carrier

Carrier protein

Custom's Needs

Deliverables

VLP Carrier (Escherichia coli)

One-stop CDMO solution for VLP carrier protein:

• Process Development: Fermentation, Purification;
• Process Scale-up and Technology Transfer;
• GMP Production: Multigram carrier protein meeting quality standard.

• Stable small-scale process, successfully scaled up to GMP manufacturing; 

• VLP carrier expression level reaches 4 g/L; 

• Protein purity, endotoxin, and other impurities meet the quality standards; 

• Delivery of multigram recombinant protein and COA documentation.

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