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:
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:
Flyer: High-quality Stabilizers for Your Biomolecules
Flyer: Granulated Products
Webinar: Addressing Raw Material Handling Challenges by Dry Granulation
Webinar: Use of Excipients for Protein Stabilization in Downstream Processes
Webinar: Viscosity-reducing Excipients for Highly Concentrated Protein Formulations
Protein-based therapeutics are prone to aggregation during manufacturing and long-term storage. Aggregation levels are a critical quality attribute to ensure the safety and efficacy of protein-based drugs. The proper control of aggregation throughout the manufacturing process can help avoid process delays and batch failures.
To tackle protein aggregation challenges in the manufacturing process, our portfolio of high-quality sugars, polyols, amino acids, and surfactants can help you overcome these challenges in your high-risk applications. Certain impurities derived from sugars or surfactants can compromise your protein formulation stability. To mitigate this challenge, we developed a sucrose low in nanoparticulate impurities and high purity polysorbates with low peroxide content.
Administration routes that are limited by volume may require highly concentrated protein formulations that may be too viscous. Excipients can be used to reduce solution viscosity, but this bears the risk of compromising protein stability.
Our Viscosity Reduction Platform of new excipient combinations enables efficient viscosity reduction whilst maintaining protein stability. Consequently, these formulations can reach higher protein concentrations with improved processing economics, suitable for standard subcutaneous injection.
To reduce caking behavior of chemicals, speed up manufacturing, and increase operator safety, we offer granulated materials that are free-flowing and easy to handle for improved raw material handling in biomolecule processes. Our granulated raw materials are low in endotoxins and are part of the Emprove® Expert Chemicals portfolio which includes comprehensive documentation to support regulatory processes.