Corynex® A New Solution to Protein Expression

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biologic medicines

large molecules made in living organisms to produce proteins which treat diseases

Biologics offer treatments for some of the most challenging diseases including cancer,

HIV/AIDS, Alzheimer’s disease, and more. By reconstructing segments of DNA, researchers are able to produce the desired proteins (recombinant proteins), which target a specific disease.

Worldwide nearly 200 biologic medicines have transformed the

lives of over 800 million patients with serious diseases.

Protein Expression Systems are how these proteins are produced.

What is a Protein Expression System?

Protein Expression Systems refer to the type of living organism that is used to grow the desired protein.

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The most common expression systems for recombinant biopharmaceuticals are:

Each system varies with respect to protein quality, cost, expression amount, and speed.

Microbial Expression Systems

Advantages:

• Affordable

• Easy to Culture

• Grow Fast

• High Titer

Drawbacks:

• Low Purification Yield

• Misfolded Protein

• Aggregation

• Protein Degradation

• Denaturation

• Cost/Time of purification

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Is there a Solution?

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Yes!

Corynex® is a

breakthrough, patented

system that overcomes common challenges with conventional microbial expression systems by allowing for:

• Isolation of higher yields

• Biologically active proteins

• Accurate folding

• Fewer host proteins

• Increased purity

• No endotoxins

So what exactly is Corynex? Corynex uses the strand of bacterium,

Corynebacterium glutamicum to

produce these complex and difficult-to-express proteins

Corynebacterium glutamicum: Discovered in Japan (1956) as a producer of amino

acids for food production

Gram-positive soil bacterium

Generally Regarded as Safe (GRAS)

Ajinomoto Althea discovered it can express therapeutic proteins tremendous biopharma impact

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Non-sporulating, non-pathogenic, non-endotoxic

How does Corynex® work?

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Promoter Target protein DNA Target protein

Transformation Cultivation

Recombinant Corynebacterium glutamicum

Plasmid vector

Signal peptide

Corynebacterium glutamicum

Secretion

Corynex® transforms Corynebacterium glutamicum with DNA plasmids containing the target recombinant gene.

This gene is transcribed using RNA polymerase producing an mRNA message. The mRNA message is bound to a ribosome complex and begins translation into an unfolded protein molecule containing a unique peptide signal sequence.

These protein molecules begin accumulating in the Corynebacterium glutamicum cytoplasm before they are ready for secretion.

The proteins are then secreted though one of 2 pathways: SEC pathway and TAT pathway, and accurately fold directly in the media.

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Corynex Process

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IGF-1

Fermentation

Separation

Chromatography

IGF-1

Fermentation

Separation

Lysis Separation

Refolding Chromatography

IGF-1 production process using E.coli

IGF-1 production process using Corynex®

Corynex Track Record (since 2009)

• 7 out of the Global Top 20 Pharma • Licensed by a Big Pharma company • Mid-size Pharma, Ventures etc. • USA, Europe, Japan, Asia

Number of Customers: >50 companies

Trial Expression: >150 proteins

• Therapeutic proteins, reagent proteins, enzymes etc.

Expression success rate: >40%

• Impressive considering Corynex is often tried when others have failed.

• SEC pathway, TAT pathway, Fusion method • Improved success rate by utilizing all 3 methods

Process Development: >10 proteins

• Over 10 proteins have gone through entire process development stages

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So Why Look into Using Corynex?

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Secretes protein directly into media

No need for cell disruption

High initial purity

Less purification steps

Proteins already in active form

No need for refolding

For our customers less downstream costs ~50 - 90% of manufacturing costs of biologics related to downstream

To learn more contact Althea at

altheatech.com/contact