Validogen

VALIDOGEN is a specialized contract development and manufacturing organization (CDMO) focused on microbial protein expression using Pichia pastoris (Komagataella phaffii). With over 15 years of dedicated expertise and hundreds of completed customer projects, the company combines technology leadership with proven industrial implementation.

Core Services

• Feasibility Studies: Early-stage assessment of protein expression potential in Pichia
• Strain Development: Targeted strain engineering to optimize protein production
• Pichia Fermentation Process Development: Cultivation optimization, fed-batch strategies, and induction protocol refinement
• E. coli Fermentation Process Development: Complementary microbial expression platform
• Protein Purification Process Development: Downstream processing optimization

Key Capabilities

• UNLOCK PICHIA® Platform: Proprietary technology supporting both methanol-induced and methanol-free Pichia fermentation, enabling flexible expression strategy selection
• High Titers: Achieved recombinant protein titers up to 45 g/L through systematic optimization of cultivation conditions, fed-batch feeding strategies, and induction parameters
• Titer Improvement: Up to 5-fold titer improvements beyond baseline platform processes through strain engineering and process optimization
• Scale-Up Proven: Processes successfully transferred to GMP manufacturing at 100,000 L and industrial production volumes up to 200,000 L
• Tech-Transfer Ready: Comprehensive technology transfer packages including process descriptions, development data, optimization rationale, and operating parameters for implementation by internal manufacturing teams or CMOs

Applications

Services support biopharma applications as well as food and feed industries.