-- Creative Enzymes today launched its entirely revamped fermentation and scale-up service, a paradigm shift for biopharmaceutical developers, industrial biotechnology companies, and academic researchers struggling with the infamous “valley of death” between successful laboratory outcomes and a commercializable product.
The biotechnology industry still experiences alarming failure rates in the scale-up of processes, where the statistics indicate that, on average, 65-70% of promising biologics experience significant decline in yield, loss of quality, or fail altogether when transitioning from bench to commercial scale up. Creative Enzymes’ new fermented platforms tackle these core challenges head on through the integrated approach of computational modeling, state-of-the-art monitoring technologies, and decades of bioprocess experience.
“Failures at scale up never stem from one factor alone, there are complex interactions occurring between hydrodynamics, mass transfer phenomena, and cellular physiology that do not change linearly with scale,” explains the Chief Scientific Officer at Creative Enzymes. “Traditional approaches, insisting on maintaining conventional scale-up parameters like kLa, power per unit volume, and tip speed, have abjectly failed to account for today's complex biological systems.”
Creative Enzymes' proprietary platform pairs CFD modeling with genome-scale metabolic models, and transcriptional profiling, allowing it to fully understand and proactively predict scale dependent phenomena before they become failures at scale. Creative Enzymes models examine unique bioprocesses to create predictive models to understand bottlenecks in oxygen transfer, nutrient gradients, and cellular stress responses at any scale.
Creative Enzymes’ improved fermented scale up service solves the most common technical limitations in bioprocessing scale-up:
1. Management of Metabolic Burden
For recombinant protein production, the platform utilizes dynamic induction approaches based on timely monitoring of cellular redox state and ATP flux, significantly improving heterologous protein expression and maintaining cell viability during high-density fermentation, addressing a major pain point for therapeutic protein producers.
2. Mass Transfer Optimization Beyond Conventional Parameters
The company uses advanced impeller designs and computational simulation, not just to maintain homogeneity for practical high-viscosity fermentations, including filamentous fungi and high cell-density bacterial cultures. Clients regularly mention that maintaining oxygen transfer during bioprocessing scale-up has been problematic when growth rates approaching productivity are clearly constrained by oxygen transfer.
The company has already had success demonstrating up to a 73% improvement in volumetric productivity for problematic yield proteins in Pichia pastoris and E. coli bioprocesses compared to conventional scale-up approaches.
3. Process Robustness Through Multifactorial Design Space Mapping
Creative Enzymes does not just optimize for productivity, it develops robust operating windows that provide buffers for contingent outcomes during large-scale environmental perturbations. Using a quality-by-design method, it accounts for sensitivity analysis of over 20 predetermined process parameters to develop predictive models for real-time decision of process control.
The expanded capabilities now encompass microbial and mammalian expression systems, filamentous fungi, and algae, with targeted protocols for problematic proteins, sensitive metabolites, and complex glycoproteins.
As regulatory agencies increase scrutiny on process comparability and the communications of biological therapeutics pathways to market, Creative Enzymes’ advanced fermentation and scale-up service represents a critical tool for researchers traversing the complex motions required to move their product from discovery to commercialization.
About Creative Enzymes
Creative Enzymes is a leading provider of enzyme products and bioprocess services for life science and biotechnology industries, specializing in solving complex technical challenges in biological manufacturing across pharmaceutical, food, biofuel, and industrial sectors.
Contact Info:
Name: Iva Colter
Email: Send Email
Organization: Creative Enzymes
Website: https://www.creative-enzymes.com/
Release ID: 89161800
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