Biomolecule Formulation

Biologics are therapeutics that can be based on proteins, peptides, viruses, viral vectors, or nucleic acids. They require a defined environment to remain intact and functional throughout the manufacturing and formulation process, as well as during long-term storage. Usually, the formulation for biologics takes place in the final ultrafiltration/diafiltration unit operation step, where the processing buffer is exchanged with the formulation buffer, and the concentration is adjusted to the required target.

In formulation development, there are several approaches that will have an impact on the success of your biologic:

• Optimizing the pH of your buffer system
• Adding inorganic salts for osmolarity adjustment (if needed)
• Selecting high purity stabilizing excipients, such as surfactants, amino acids, and sugars
• Selecting excipients to optimize solution viscosity (for protein formulations at higher concentrations)

To support your biopharmaceutical formulation development and manufacturing, we provide materials low in bioburden and endotoxins. These materials are supported with our Emprove® Program which provides extensive documentation to help you minimize regulatory and quality-associated risks and includes:

• Buffers
• Salts
• Stabilizers
• Viscosity-reducing excipients