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Corynex®
A New Solution to Protein Expression
1
2
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.
3
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
4
Is there a Solution?
5
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
6
Non-sporulating, non-pathogenic, non-endotoxic
How does Corynex® work?
7
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.
Step 1 Step 2 Step 3 Step 4
Corynex Process
8
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
(since2009)
• 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
9
So Why Look into Using Corynex?
10
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

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Frustrated with Protein Expression?

  • 1. Corynex® A New Solution to Protein Expression 1
  • 2. 2 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.
  • 3. What is a Protein Expression System? Protein Expression Systems refer to the type of living organism that is used to grow the desired protein. 3 The most common expression systems for recombinant biopharmaceuticals are: Each system varies with respect to protein quality, cost, expression amount, and speed.
  • 4. 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 4
  • 5. Is there a Solution? 5 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
  • 6. 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 6 Non-sporulating, non-pathogenic, non-endotoxic
  • 7. How does Corynex® work? 7 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. Step 1 Step 2 Step 3 Step 4
  • 8. Corynex Process 8 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®
  • 9. Corynex Track Record (since2009) • 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 9
  • 10. So Why Look into Using Corynex? 10 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