_

Cell Line Development

Our cell line development provides a safe and cost-efficient basis for your project. With our cell line platforms we offer solutions for all clients and products, be it extreme titers, extra fast development times, fully human and/or specific glycosylation patterns, or the efficient expression of very difficult to express proteins.

Have a look on our cell line technologies

  • GMP compliant and suitable cell lines for R&D to commercial market
  • CHO and human cell line based platform technologies
  • Glycosylation optimisation (fucose, mannose and sialic acid content)
  • Manufacturability and developability testing
  • Mock cell line generation
  • Accelerated cell lined development in 4 months
  • Cell line stability studies
  • cGMP cell banking and storage
  • Documentation for IND filing
_

USP Development

Our USP development team is highly experienced and provides you with robust and cost-efficient processes. We have developed media and know how to adapt and to optimize them in order to increase expression titer, strengthen cell viability. On average, we double and sometimes more than triple the titer of a developed cell line during the USP development.

  • Media development/optimisation
  • Feeding development/optimisation
  • Optimization of process parameters
  • Shear stress testing
  • 1 L, 10 L and 100L bioreactor systems for non-GMP development and pilot runs
_

DSP Development

Efficiency is key for a good downstream process : to consistently obtain a pure and high quality product while recovering as much target protein as possible. Celonic has set-up a downstream platform process for antibodies recovering more than 75 % of the target protein. This saves you considerable development time and costs. In addition our experience in process development for non-antibody products enables us to maximize the recovery rate during platform adaptation.      

  • Adaption of State-of-the-art processes for mABs
  • Process development for non-antibody products
  • Process intermediate stability studies
  • Virus clearance studies
  • Extensive experience in purifying products from inhouse CHO cell line
_

GMP Manufacturing

Our GMP facilities at our two locations are top-of-the-line. Therefore, we can promise drug substance manufacturing under cGMP. Our multiple GMP suites are ready for fed-batch and perfusion production in single-use or stainless steel bioreactors. Celonic’s USP and DSP platform technologies together with an integrated quality control system and total quality management are adapted to deliver best-in-class material for your clinical trial or commercial product.

This is why, we consistently deliver high class biologics for our clients therapeutic areas. No molecule is too difficult for us. We have GMP processes ready for human and CHO cell lines.

  • Several USP and DSP suites available
  • Process validation according to GMP guidelines
  • Production for all clinical trial phases according to GMP
  • Production for commercial products according to GMP 

_

Fill & Finish

To increase speed to clinic of your future medicine, we offer you our fill and finish services for liquid formulated drug products. The production of the clinical samples can be done in a highly flexible facility setup. We adapt the GMP-compliant process to the dosage, formulation and filling needs for your drug product. 

  • Semi-automatic sterile filling of aseptic liquids for clinical trial
  • Media fills are performed for new primary packaging systems
  • Various glass vial sizes
  • Complete quality control for release
  • Labeling, packaging, and shipping of clinical samples