GMP-grade Antigen Production for Vaccine

Creative Biolabs can offer you a full development package from proof of concept through to cGMP scale up in different expression systems to produce antigens for your vaccine development. Our fermentation laboratories are equipped with state-of-the-art fermenters and bioreactors that allow us to express proteins on a large scale. Our clients can choose to enter the protein expression pipeline at any stage as needed, and then we can make manufacturing and development proposals as required. Our rigorous quality control system will record all manufacturing and quality processes to ensure your needs are met. Each batch of GMP protein is formulated with COA to ensure consistent performance.

Features

• Various expression systems available for production.
• Well-characterized and tested cell banks.
• Independent pilot production suites to imitate manufacturing operation and process flow for process development.
• Scalable equipment/technology for promoting technology transfer and mass production of large product lots.
• Dedicated upstream and downstream cleanroom suites.
• Independent QC and analytical testing laboratories.

Development Process

1. Cell Line Development

• Construction of stable cell lines with certificated host cells and vectors.

2. Fermentation

3. Downstream Purification

• Cell harvest by continuous centrifugation or filtration
• Cell lysis (chemical or mechanical methodologies)
• Supernatant concentration/buffer exchange
• Column chromatography
• Protein refolding
• Tangential flow filtration (TFF)
• Ultrafiltration

4. Quality Control Testing

• N-terminal sequencing, HPLC, MS, SDS-PAGE, total protein, endotoxin, mycoplasma, presence of host cell content, adventitious agents, sterility testing, bioactivity testing and more.

5. Process Scale-Up & QC

6. Fill & Finish, Packaging, Labelling

7. Documentation

• Lot-to-lot consistency, materials traceability, equipment maintenance, and monitoring records, Drug Master Files, and other GMP certificate will be provided by Creative Biolabs.

Protein Production Systems

• Escherichia coli. System. The most widely used bacterial system is E. coli because they are well-understood in genetics, genomic sequence, and physiology. The genetic manipulation is simple and they are suitable for large-scale fermentation.
• Yeast. Expression of proteins in yeast is a common alternative to prokaryotic and higher eukaryotic expression. Yeast cells take the advantages of producing proteins in microbes (growth speed, easy genetic manipulation, low-cost media) while offering some of the attributes of higher eukaryotic systems (post-translational modifications and secretory expression).
• Baculovirus-infected cells. Baculovirus-insect expression system has been relatively mature in many labs for protein production and is becoming a leading method to produce high-quality proteins among the eukaryotic expression systems.

• Mammalian Cell Expression System for Vaccine. Mammalian expression systems can be used to produce proteins transiently or through stable cell lines and large amounts of proteins can be produced in one or two weeks. These transient, high-yield mammalian expression systems use suspension cultures and can produce gram-per-liter yields.
• Cell-free systems. The cell-free protein expression system (CFPS) utilizes enzymes and protein factors derived from cell extracts, exogenous DNA or mRNA as a template, and complements the substrate and energy substances required for translation to achieve in vitro synthesis of the target protein.

Contact Creative Biolabs today to discuss how we can use our expertise and capabilities to drive your vaccine products from the lab to the factory.

All of our products can only be used for research purposes. These vaccine ingredients CANNOT be used directly on humans or animals.