What Should a Request For Proposal (RFP) Actually Ask?
July 29, 2026
A biologics CDMO RFP should do more than collect capabilities, timelines and prices. At late stage, the purpose of the request is to reveal
Category: Blog
Is Your Analytical Package Ready for GMP?
June 30, 2026
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
June 18, 2026
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
May 26, 2026
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
May 12, 2026
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
April 21, 2026
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…
Why GMP Readiness Starts During Drug Development, Not at Clinical Phase
April 7, 2026
Most biotech teams assume GMP readiness begins when a product enters clinical phases. In reality, the foundations of GMP are built much earlier, during drug development, often without being explicitly labeled as such. Drug Development…
How to Scale Manufacturing Without Losing Quality or Compliance
March 25, 2026
Scaling manufacturing is one of the most misunderstood transitions in biologics development. Many teams assume that if a process works at small scale, it will behave similarly at larger volumes. In reality, scale up in manufacturing is not…
53Biologics boosts its GMP biomanufacturing expansion with an investment led by Ren Life Sciences and supported by Inveready
March 25, 2026
VALLADOLID, MARCH 25, 2026 53Biologics, a biotechnology company specialising in the development and manufacturing of biological drugs, has announced the closing of a strategic financing round led by the specialist European private equity…
Understanding the Manufacturing Responsibilities for Drug Substances and Drug Products
March 11, 2026
Understanding the responsibilities involved in Drug Substance and Drug Product manufacturing is essential for making the right strategic decisions. Many biotech companies approaching clinical phases discover that the distinction between…