Expert Protein Manufacturing

At Wacker Biotech, we bring over 30 years of expertise in producing recombinant proteins for a variety of therapeutics. Our unique capabilities in microbial production make us the perfect partner to guide you through the development and manufacturing of even the most challenging proteins.

Innovative Solutions for Protein Expression

We offer two proprietary platforms based on E. coli microbial systems:

ESETEC^® Platform: This cutting-edge technology allows for the controlled release of correctly folded proteins at high yields. It's a cost-effective alternative to traditional methods and has been successfully used for producing a wide variety of recombinant proteins. Explore more
FOLDTEC^® Technology: Ideal for insoluble proteins, this platform leverages our extensive experience in designing highly efficient refolding processes. Explore more

Protein Capabilities

Strain Development
Generation and selection of the top-performing E.coli strains based on our proprietary strains
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Development of Customized Processes
A dedicated process development lab to support feasibility, process development and optimization as well as comparability
Technology Transfer
Flexible and experienced MSAT teams to accommodate your customized protein processes
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Analytical Capabilities
Comprehensive analytical portfolio for product release, cell-based assays and stability studies
GMP Cell Banking
Master and working cell bank production
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GMP Manufacturing
Scalable production from 43 L to 1500 L scale for BSL 1 and 2 products for clinical trials or commercial supply. Learn more about our state-of-art production facilities. Learn more
Innovative Solution for Half-Life Extension:
- PASylation^®
  An Innovative Solution for Half-Life Extension. Learn more
- PEGylation
  Wacker Biotech has extensive expertise in the development and performance of the PEGylation step of biologics and synthetic peptides in our GMP facilities

Types of Recombinant Proteins

Wacker Biotech’s expertise encompasses a wide range of often difficult-to-produce molecules:

Proteins of prokaryotic, eukaryotic or artificial origin
Proteins with a wide range of molecular weights (5 kD – 150 kD) and isoelectric points
Monomers – tetramers – heterodimers
Fusion or native proteins
Proteins with authentic N-termini and different starting amino acids
Proteins with multiple disulfide bridges
Novel antibody formats (e.g. single domain antibodies) and antibody fragments (e.g. Fab)
Scaffolds
Peptides
Enzymes
Growth factors (e.g. hGH)

Key Benefits of Wacker Biotech’s pDNA Services

Proven Track Record
With more than 30 years of experience, over 300 successful batches and numerous satisfied clients, we are leaders in microbial production of biologics.
Comprehensive Capabilities
From strain development and customized process development to GMP manufacturing and analytical capabilities, we offer a full suite of services to meet your biopharmaceutical needs.
State-of-the-Art Facilities
Our scalable production facilities can handle everything from clinical trials to commercial supply, ensuring the highest quality and efficiency.
Solutions for Difficult-to-Produce Proteins
Our particular expertise is manufacturing difficult-to-produce molecules thanks to our proprietary ESETEC^® and FOLDEC^® platforms, which we are continuously enhancing with new innovations.

Ready to Partner with Us?

Discover how Wacker Biotech can transform your biopharmaceutical production. Contact us today to learn more about our innovative solutions and how we can help you achieve your goals. Reach out to our team for more information.

Product/Customer Spotlight

nomacopan for Akari Therapeutics

Customer: Akari Therapeutics
Product: nomacopan, a protein-based therapy for autoimmune and inflammatory diseases
Scope: Use of proprietary ESETEC® technology for process development and manufacturing

For Akari Therapeutics, Wacker Biotech used our patented ESETEC^® technology to develop and optimize a production process for nomacopan, an advanced protein-based therapy for autoimmune and inflammatory diseases. The latest generation of ESETEC^® has been able to increase the yield of investigational nomacopan significantly by a factor of 12. Comparative studies have shown that the quality of the proteins remained consistently high after the switchover to new strains. This demonstrates the effectiveness and excellence of our ESETEC^® system.

GM-CSF (granulocyte-macrophage colony-stimulating factor) for Hubro Therapeutics

Customer: Hubro Therapeutics
Product: GM-CSF (granulocyte-macrophage colony-stimulating factor)
Scope: Use of proprietary FOLDTEC^® technology for process development and manufacturing

Hubro Biosciences engaged Wacker Biotech to produce a growth factor cytokine to serve as a stimulant to enhance the immune response elicited by a prospective peptide cancer vaccine. Transferring this relatively insoluble protein into its active conformation is challenging due to the folding that occurs during fermentation. Traditional refolding typically requires large working volumes, and published yields have been notoriously low. Using our proprietary FOLDTEC^® E. coli strain to express the cytokine, we were able to achieve high yields of 90% while maintaining exceptional purity. Both an engineering run and final GMP production run for Phase I/II clinical trial material were conducted.