03.23.23 -- Ensuring Success From Early Stage In The Biopharma Business

Biopharmaceutical companies seek to reduce technical and regulatory risks while also ensuring easy access to capacity at various scales. To this end, the key differentiators between potential CDMO partners are responsiveness to industry demands and ability to expand capacity while concurrently investing in new technologies or modalities that support industry growth.

An experienced contract manufacturer can help drug developers to better utilize valuable internal resources, leverage a deep pool of industry experience, and mitigate risk across development cycles — staying competitive in a rapidly evolving market. However, finding the right combination of services, culture, expertise, and capacity is critical.

BsAbs’ dual specificity opens a wide range of applications, including redirecting T cells to tumor cells, simultaneously blocking two different signaling pathways, and dual targeting of different disease mediators. Consistent production of structurally complex molecules that exhibit high yield and purity requires keen expertise and experience.

Successful CDMOs build client confidence by demonstrating the understanding needed to develop a robust and scalable process, backed by biostatistics and quality by design (QbD), in support of cGMP manufacturing. Examine how combining scaled-up manufacturing data with small-scale understanding can maximize production cadence.