• Xendo CTM press release.pdf
• Persbericht Xendo CTM.pdf

Xendo CTM

Xendo has started (building) a new multi-purpose GMP facility at the premises of the University Medical Center Groningen (UMCG) for the early stage GMP manufacturing of clinical trial material for pre-clinical, and phase I and phase II clinical trials. This new multi-purpose GMP facility utilizes the broad range of services offered by Xendo as well as the (pharmaceutical) capabilities of its strategic alliance partners.

The unique selling points are:

• One-stop-shop early-stage CMO (full service)
• Speed and low costs to Proof of Concept
• Process and analytical development power
• Use of disposables (including novel DSP technology: BioSMB)
• No scale-up commitment but guaranteed technology transfer

Products offered:

• Cell banking
• Mammalian products
• Bacterial products
• Viral products
• Plasmid DNA
• Cell therapy (stem cells, cell processing)

Separate zones and containment areas in the GMP plant:

• - Cell processing: class A & B
• - Mammalian and viral processing: USP class D, DSP class C
• - Bacterial and plasmid DNA processing: USP class D, DSP class C

Additional product / service offerings:

• Cell line development (Xendo strategic alliance partners)
• Process development (Xendo pilot laboratory)
• Analytical development and QC (Xendo laboratories)
• Formulation development (Xendo strategic alliance partners)
• Regulatory Affairs, Validation, QA, Engineering (Xendo pharma services)
• Filling (Xendo strategic alliance partners)
• Labeling & packaging (Xendo strategic alliance partners)
• Stability studies (Xendo strategic alliance partners)

Target group:

• Small biotech
• Middle size biotech
• Research groups, Institutes

Contact:

• Drs. ing. Ard Tijsterman (managing director), tel. + 31 (0)71 524 4000
• Dr. Coba van Zanten (technical director), tel. + 31 (0) 050 361 8043