Mammalian Cell Culture

Process development and protein production based on mammalian cells is conducted by our wholly-owned subsidiary BIBITEC.

Cell Line Development

We are able to work with different cell lines and support out customers during cell line development as well as the generation of GMP compliant Master (MCB) and Working (WCB) cell banks.

Mammalian Expression Systems:

• Predominantly CHO, HEK293, hybridoma cell lines, plant cells
• Stable and transient expression
• Cell line development, screening ¹
• Characterization, banking under GMP condition…
• and stability testing in cooperation with partners according to ICH guideline

^[1] with partners

Upstream Process Development (Mammalian Cell Culture)

Upstream development of mammalian cell culture based processes is conducted at our site in Bielefeld (Germany) by BIBITEC.

The portfolio starts form lab scale (<1 L) for the development of novel production processes to pilot scale (up to 200 L) for the manufacturing of pre-clinical and clinical supply in a GMP environment. Setup of a production facility for commercial production of your product at our company is possible together with our engineering department.

At BIBITEC we offer the following services to our customers during mammalian cell culture development:

• Cultivation of mammalian cell lines both adherent and in suspension
• Serum-free and protein-free adaptation
• Univariate as well as multivariate (DoE) experimental studies
• Media evaluations for optimized growth and productivity
• Development of batch, fed-batch and perfusion cultivation processes
• Scale up from lab (< 1 L) to pilot scale (up to 200 L)
• Both glass and disposable systems
• Technology transfer

Downstream Process Development

Downstream development of cell culture based processes is conducted in our laboratories in Bielefeld (BIBITEC).

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

At BIBITEC we offer the following services to our customers during downstream process development:

• Development of chromatographic purification steps
• Development of filtration steps
• Platform based purification processes for mabs
• Individual purification processes (i.e. enzymes, cytokines etc.)
• Implementation and validation of virus removal steps
• Host cell protein and DNA removal
• DoE studies for process optimization
• DoE studies for evaluation of process robustness and reproducibility (Design space)
• Scale-up und Scale-down studies
• 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 new established facilities with state-of-the-art equipment under GMP conditions and appropriate clean rooms at our BIBITEC site at Uetersen. For these products we offer the entire value chain, from active pharmaceutical ingredients through all intermediary steps up to the finished drug product.

BIBITEC offer upstream capacities for mammalian cell culture derived products in our pilot facility up to 200 L disposable bioreactors with corresponding downstream capacities.

At BIBITEC we 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
• GMP production of drug product in cooperation with partners

Mammalian Cell Culture

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Contact us:

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