Microbial Fermentation

Strain Development and Cell Banking

At Nordmark we develop robust production hosts for high yield in recombinant and non-recombinant protein production. During development we are able to apply genetic engineering tools and screening experiments to obtain and identify the ideal production host. The generation of GMP compliant Master (MCB) and Working (WCB) cell banks can also be conducted in our cell bank facilities.

At Nordmark we can offer the following services to our customers during strain development of microbial expression systems:

• Handling of bacteria and yeast strains (up to BSL 2)
• Production host adapted codon usage of target gene
• Vector-gene design
• Screening experiments for identification of ideal production host
• Production host characterization
• Generation and Storage of Master and Working Cell Banks under GMP conditions
• Stability testing of Master and Working Cell Banks according to ICH guidelines

Upstream Process Development (Microbial Fermentation)

Microbial fermentation development is conducted in our biotech development laboratories with aerobic and anaerobic cultivation capacities. Core competences are the cultivation of microbial organisms such as bacteria and yeasts for high yield production of protein-based pharmaceutical ingredients.

The development includes screening experiments (mL scale) and process development in parallel bioreactor systems (1 L). Thereby, we also apply univariate as well as multivariate (DoE) experimental studies flanked by analytical process characterization including in-process and quality control setup. Primary recovery steps are also belonging to our competences.

The portfolio starts form lab scale to pilot scale (up to 500 L) for the manufacturing of pre-clinical and clinical supply in a GMP environment. Process transfer and setup of a production facility for commercial production of your product at our company is possible together with our engineering department.

At Nordmark we can offer the following services to our customers during microbial fermentation development:

• Cultivation of bacteria and yeast strains
• Cultivation under aerobic and anaerobic conditions (up to BSL 2)
• Univariate as well as multivariate (DoE) experimental studies
• Media development for optimized growth and productivity
• Development of batch and fed-batch fermentation processes
• Development of primary recovery steps
• Scale up from lab (< 1 L) to pilot scale (up to 500 L)
• Technology transfer

Downstream Process Development

Downstream development is conducted in our laboratories of the process development department at Nordmark.

Due to our state of the art technical equipment (e.g. ÄKTA-Systems at laboratory- and pilot-scale), our highly qualified and experienced staff we can offer the purification of highly sensitive and complex biotechnological substances, such as proteins (i.e. enzymes, mAB’s), in which activity must be preserved. The downstream process solutions developed in laboratory or pilot scale can subsequently be transferred to an industrial production scale.

At Nordmark we can offer the following services to our customers for downstream process development:

• Development of chromatographic purification steps
• Development of filtration steps
• Platform based purification processes (e. g. mabs)
• Individual purification processes (i.e. enzymes etc.)
• Host cell and DNA removal
• Analytics (method transfer, development)
• DoE studies for process optimization
• DoE studies for evaluation of process robustness and reproducibility (Design space)
• Scale-up und scale-down studies (1 mL to > 100 L)
• GMP-compliant downstream processes
• Technology transfer

Biomanufacturing under GMP Conditions

Supply of active investigational biopharmaceuticals for Phase I to III clinical trials conducted in our established facilities with state-of-the-art equipment under GMP conditions and appropriate clean rooms. For these products Nordmark can offer the entire value chain, from active pharmaceutical ingredients through all intermediary steps up to the finished drug product.

Nordmark Biotech can offer upstream capacities for microbial derived products in our pilot facility up to 500 L (microbial) bioreactors with corresponding downstream capacities.

At Nordmark we can offer the following services to our customers for GMP-production:

• Sophisticated and state-of-the-art equipped GMP facilities
• GMP production of drug substance for clinical supply
• Process transfer and commercial product supply
• In-house quality assurance and quality control for product release

Microbial Fermentation

Contact

E-Mail: projects(at)nordmark-biotech.de