MilliporeSigma says viscosity tech overcomes manufacturing challenges

MilliporeSigma has launched a Viscosity Reduction Excipient Platform, which it says helps tackle production and formulation issues associated with highly concentrated protein solutions.

According to Merck’s Life Science business MilliporeSigma, the Viscosity Reduction Platform can address specific needs of different protein-based therapeutics through the combination of amino acids and anionic components.

“MilliporeSigma’s new Viscosity Reduction Excipient Platform reduces interactions between proteins (including antibodies) that make the product too thick to pass through an injection needle,” Matthias Bucerius, head of actives and formulation at MilliporeSigma told us.

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“The platform does this by combining different excipients that when used together improve each other’s efficiency. The more interactions between proteins can be reduced, the more fluid the drug product becomes, so that it can be applied through a syringe.”

According to MilliporeSigma, for protein-based therapeutics, such as plasma derived proteins or monoclonal antibodies (mAbs), subcutaneous administration is the favoured method as it can improve patient agreement.

However, to meet the intended dose, the formulation typically requires highly concentrated protein formulations. Highly concentrated protein solutions often show increased viscosities, which is a challenge in the production process and final formulation.

“Our platform is more efficient in terms of viscosity reduction than other solutions that are currently used,” said Bucerius.

He continued: “It  can reduce viscosity stronger than current standard solutions. Also, it provides the formulation scientist with alternative new excipients to use if commonly used excipients cannot be used. Our technology offers a better balancing of viscosity and protein stability, which ultimately enables the formulation scientist to create a stable drug product suitable for a convenient route of administration.”

All excipients will be made available on MilliporeSigma’s Emprove Expert, which has been designed to help speed up internal qualification procedures and support your clinical development and commercialization.