From Cell to Clinic, Faster: A Practical Playbook for Ingredient-Driven Bioprocessing in 2026
Here are the Top Bioprocessing Pressures and how DKSH’s ingredient portfolio directly addresses them:
Key Pressure / Question | Industry Concern | Ingredient Role | How DKSH Ingredients Provide the Solution |
1. How do we sustain high cell density without compromising yield? | CHO and HEK systems often plateau due to nutrient depletion or toxic metabolite build-up. | Amino acids, protein hydrolysates, yeast extract, carbohydrates & sugars | Amino acids and sugars supply sustained energy; hydrolysates and yeast extract enhance biomass and productivity. DKSH sources GMP-grade materials with validated consistency, minimizing variability that disrupts titer. |
2. How can we control pH and stability during high-density cultures? | Rapid metabolic activity leads to acidification and unstable growth. | Biological buffers, inorganic salts, organic salts | Buffers and salts regulate pH, osmolarity, and ionic strength. DKSH provides validated, pharmacopeia-grade materials that maintain stable culture conditions across scales. |
3. How do we ensure reproducibility in peptide and ADC synthesis? | Non-natural amino acid incorporation, solvent purity, and denaturant variability create impurities. | Specialty amino acids, acids, solvents, denaturants | GMP-protected amino acids ensure clean synthesis. High-purity solvents and denaturants reduce impurities and enhance reproducibility. DKSH ensures regulatory compliance (DMF/IND support) to avoid delays. |
4. How do we stabilize fragile biologics like nanobodies or fusion proteins? | Novel formats are prone to aggregation and instability in formulation. | Hormones, lipids, carbohydrates, amino acid-derived excipients | Lipids and hormones protect structural integrity; carbohydrates and amino acid derivatives enhance folding and stability. DKSH provides excipients designed for next-gen proteins, ensuring shelf-life and efficacy. |
5. How do we manage compliance and regulatory audits on raw materials? | Regulators increasingly demand full traceability and GMP certification. | All ingredient classes (buffers, salts, solvents, hydrolysates, etc.) | DKSH secures regulatory-ready documentation, GMP certification, and full traceability. Our global quality systems ensure raw materials meet EMA/FDA expectations, reducing risk of non-compliance. |
6. How do we avoid delays caused by global supply chain fragility? | Ingredient shortages or logistics bottlenecks disrupt critical R&D timelines. | Global ingredient sourcing across all categories | DKSH’s global network ensures continuity, backed by secure cold-chain and local warehouses. This mitigates tariff, freight, and import delays, safeguarding clinical and commercial supply. |
With DKSH, you gain:
- Regulatory-ready raw materials (GMP-grade, validated, with full documentation).
- Supply chain security (global sourcing + local delivery).
- Technical support from regional innovation centers to optimize formulations and minimize waste.
Connect with DKSH today to secure the ingredient portfolio that will take your therapies from cell to clinic — faster, safer, and more compliant.