Explore BioXPro™, the Croda multi-compendial cGMP amino acids offering with ultra-low levels of metals and endotoxin

Amino acids are the fundamental building blocks of proteins and play a critical role in various bioprocessing applications. From cell culture media to protein formulation, the selection and management of amino acids are central to driving efficiency, yield, and product quality in the biomanufacturing industry.

Explore BioXPro™ Amino Acids

Croda’s multi-compendial cGMP amino acids offer ultra-low levels of metals and endotoxin that reduces any potential variation in performance, resulting in high quality and improved batch-to-batch consistency for a range of pharmaceutical applications.

Role of amino acids in bioprocessing

• Cell culture media: Amino acids are vital ingredients in cell culture media, providing nutrients for the proliferation and maintenance of mammalian, microbial, and insect cell lines.
• Protein expression: Supplementing the right balance of amino acids enhances recombinant protein expression, ensuring proper folding and biological activity.
• Metabolic regulation: Amino acids influence cell metabolism, affecting by-product formation, cell viability, and process robustness.
• Product quality: The profile and concentration of amino acids can impact glycosylation patterns and other critical quality attributes of biopharmaceuticals
• Downstream purification: Amino acids can offer milder alternatives in protein washing steps and viral inactivation, improved separation in polishing and enhanced protein solubilisation and refolding.

Role of amino acids in formulation

Amino acids play a crucial role in biologic formulation, not only serving as essential building blocks for the protein-based therapeutic itself but also contributing to the stability and efficacy of the final product. In formulation development, specific amino acids may be included as stabilisers, pH buffers, or osmolytes, to enhance protein solubility, prevent aggregation, and improve shelf-life. Additionally, the careful selection and concentration of amino acids can mitigate degradation pathways, such as deamidation or oxidation, ensuring product quality is maintained throughout storage and administration.