mAbs Scale-up video

Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products. Watch this video to learn more about:

Parenteral drugs are becoming increasingly complex, creating new challenges and opportunities. This paper explores potential innovations across the entire value chain.

Despite selecting the right, compendial excipients for a balanced formulation, you may encounter obstacles that delay market deadlines. Learn how to streamline the formulation and fill-finish process with the right raw material selection, secure and efficient fluid pathway design, comprehensive regulatory support, and supply chain transparency.

Biopharma companies often lack the capacity and infrastructure to handle large buffer volumes needed for mAb production. Avantor offers four key strategies to improve operational efficiencies and reduce facility footprint, such as pre-weighed, GMP-compliant raw materials or ready-to-use hydrated solutions. Learn more about these customizable solutions.

The growing complexity of therapeutic monoclonal antibodies (mAbs), especially bispecific antibodies, presents significant manufacturing challenges such as instability, low yields and aggregation. This article explores innovative solutions, including detergent-based viral inactivation as an alternative to low pH treatment, high- performance chromatography ligands and advanced formulation excipients.

Can biopharma manufacturers avoid extra costs, potential problems and wasted production time by designing a fully compliant (cGMP) manufacturing process early on? This article explores where planning ahead, using compendial raw materials of the highest quality and purity, can yield substantial benefits to both productivity and patient safety.