Research and Development Services

We have many years of experience in the development of biological therapeutic agents. Our expertise ranges from identifying and developing suitable proprietary expression systems to protein purification processes. The course of the project is followed by monitoring, which is transparent to our customer. The overall development is recorded by documentation in alignment with regulatory requirements.

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The research and development services we offer include the following:

	Patent searches
Advice Patent expert report Searches
	Selection of suitable expression systems (prokaryotic or eukaryotic systems)
Genetic engineering work (safety levels S1 and S2) Proprietary systems Constructs with or without antibiotic resistance   Eukaryotic cell line   Prokaryotic cell line Transfection Clone selection Amplification Adaptation to serum-free medium Adaptation of the adherent cells to suspension Codon optimization Transformation Clone selection Media screening Small scale fermentation
	Cell bank deposition (MCB, WCB)
Eukaryotes and prokaryotes Storage in accordance with GMP Characterization and stability (prokaryotic cell banks)
	Fermentation procedures (USP) laboratory scale
4 parallel fermentation units (400 ml) 5 l (prokaryotic) + 2 l (eukaryotic) fermenter (Applicon) Cell disruption up to 1500 bar with HDH
	Development of protein purification processes (DSP)
Filtration Refolding Diafiltration Equipment Äkta Explorer Media screening (IEX, SEC, affinity, RP HPLC, HIC) Development of an efficient DSP IPC analytics Creation of specifications Production of research grade material
	Support in the transfer to a GMP manufacturer, scale-up
Contact for specific project (single point) Creation of transfer protocols Support in the implementation of fermentation or DSP Support in the development of IPC methods
	Creation of registration documents
CMC (chemistry, manufacturing, control) in the CTD (common technical document) format