Home › Updates
Updates
Insights, updates and perspectives from the 53Biologics team on biologics development and manufacturing.
What Should a Request For Proposal (RFP) Actually Ask?
A biologics CDMO RFP should do more than collect capabilities, timelines and prices. At late stage, the purpose of the request is to reveal how a
Is Your Analytical Package Ready for GMP Biologics Manufacturing?
A biologic can be ready for GMP manufacturing in the process sense and still not be ready in the analytical sense becasue the analytical package is poor defined. This is one of the most common late-stage bottlenecks in B…
Changing CDMO Late in Development: What Biologics Teams Should Know
Changing CDMO late in development may sometimes be necessary. Capacity may no longer fit the program. Timelines may have shifted. The original partner may not offer GMP manufacturing, integrated analytics, fill-finish or…
Antibody manufacturing: Beyond Capacity and Price
Antibody manufacturing decisions are often reduced to two variables: capacity and price. While both are important, they rarely determine the true success of a program. Antibody Manufacturing Is a System, Not a Service On…
How a CDMO Accelerates Drug Development
In today’s biologics landscape, drug development is no longer limited by scientific discovery alone. It is constrained by how efficiently that discovery is translated into scalable, compliant manufacturing. This is where a CDMO can either…
Recombinant Protein Production Under GMP: Key Decisions That Define Success
When companies evaluate GMP recombinant protein manufacturing, discussions often revolve around timelines, batch size or price per gram. For companies already familiar with the industry and now entering the decision stage, the key question…