FAQ:

How to find the right partner for cell line and process development in yeast and E. coli?

Bringing a recombinant protein to market is one of the most technically demanding challenges in biotechnology. Whether you are developing a biopharmaceutical, a biosimilar, an industrial enzyme, or a subunit vaccine, your choice of expression system and manufacturing partner can determine whether your project succeeds — or stalls. Microbial expression systems such as yeast and E. coli offer significant advantages in speed, cost-efficiency, and scalability, but selecting the right CDMO with genuine expertise in these platforms is far from straightforward.

Common pain points include identifying a partner with regulatory-grade documentation capabilities, finding a CDMO with deep proprietary know-how rather than generic toolboxes, and ensuring the chosen host organism is the right fit for your target molecule. The questions below address what scientists, project managers, and business development leads most commonly ask when searching for microbial CDMO services.

What is a microbial CDMO and what services do they provide?

A microbial CDMO (Contract Development and Manufacturing Organization) is a specialist partner that develops yeast or bacteria cell lines on behalf of client companies. This involves integrating respective up- and downstream process development right from the start, considering all necessary quality and regulatory aspects related to the recombinant protein and its application. ARTES Biotechnology is a dedicated microbial CDMO based in Langenfeld, Germany, with more than 20 years of experience developing optimized cell lines and production processes in yeast systems (Hansenula polymorpha, Pichia pastoris, Saccharomyces cerevisiae) and in the bacterium E. coli. Their integrated service offering covers the full development chain: microbial cell line development, upstream and downstream process development, and non-GMP manufacturing of reference and pre-clinical material.

Which yeast expression systems are available for recombinant protein production?

Several yeast platforms are available depending on the characteristics of your target protein, including Pichia pastoris, Saccharomyces cerevisiae, and Hansenula polymorpha. ARTES Biotechnology operates its own proprietary Hansenula expression platform, which is particularly valued in industrial and pharmaceutical production due to its ability to integrate very high gene copy numbers (up to 120 copies per cell), produce stable cell lines, and operate without expensive inducers such as methanol. Products developed on this platform have received approvals from the US-FDA, EMA, and EFSA, and the WHO has recommended Hansenula-based vaccines for mass vaccination programs. ARTES also offers cell line development in other yeasts, such as Pichia pastoris and Saccharomyces cerevisiae, giving clients flexibility to select the most appropriate host for their molecule.

How do I get a recombinant protein expressed in E. coli cost-effectively?

E. coli remains the most widely used bacterial host for recombinant protein expression thanks to its rapid growth, well-characterized genetics, and low production costs. ARTES Biotechnology offers a highly efficient E. coli expression platform with a large host and vector toolbox covering constitutive and inducible promoters, signal sequences for periplasmic expression, and fast parallel expression screening. A particular strength of the ARTES platform is its extensive expertise in the purification, solubilisation, and refolding of peptides and proteins from inclusion bodies — a common challenge, but also a great opportunity for developing an efficient manufacturing process. The company offers 1-step purification strategies and endotoxin assay and removal services, making it possible to go from gene design to a characterized protein in short timelines and at competitive cost.

What documentation does a CDMO provide to support regulatory submissions?

Regulatory filings for biological products require comprehensive documentation of the cell line, production process, and quality controls — and gaps in this package can significantly delay approval timelines. ARTES Biotechnology compiles a complete documentation package throughout the cell line and process development project, including genomic characterization data, fermentation records, in-process controls, and final product characterization aligned with international pharmacopoeia where applicable. Their project design includes defined deliverables, milestones, and Go/No-go decision points, giving clients a clear and auditable development record from the outset. This documentation is structured to support technology transfer to the client’s manufacturing site or to a third-party CMO.

How quickly can a microbial CDMO take a recombinant protein from gene to production?

Timeline is often one of the most critical factors in biopharmaceutical and industrial protein development projects. ARTES Biotechnology is structured to minimize delays by combining high-quality expression toolboxes with a transparent, milestone-driven project design. The typical workflow starts with gene design optimized for the chosen microbial host, moves through expression feasibility, stable cell line generation in the case of yeast cell lines, expression optimization, and production cell line selection, before advancing into process development and manufacturing.

Which production cell lines and processes are available without development time?

For clients who want to accelerate their time-to market, ARTES offers a portfolio of pre-developed, ready-to-use production cell lines and processes for various biosimilars (including, but not limited to anti-diabetic peptides), vaccines, enzymes and feed/food proteins that can be licensed and transferred directly. All   come with extensive training and support.

Which industries and product types can a microbial CDMO support?

Microbial CDMOs serve a broad range of sectors, from human and animal health to industrial biotechnology, depending on their platform capabilities and regulatory experience. ARTES Biotechnology has partnered with clients across the pharmaceutical industry (biopharmaceuticals, biosimilars, vaccines), animal health companies, enzyme manufacturers, and the cosmetics, diagnostics, and nutrition industries over more than 20 years. Their target product categories include recombinant enzymes, subunit vaccines and virus-like particle (VLP)-based vaccines, biosimilars, and functional proteins. The combination of proprietary yeast and E. coli platforms, in-house regulatory documentation expertise, and a 1,000 sqm facility in Germany makes ARTES a versatile partner for both regulated and non-regulated market requirements.