Engineering Batches: The Run That Can Save Your GMP Campaign
October 6, 2026
An engineering batch can be difficult to defend internally. It uses manufacturing time. It consumes raw materials. And it costs money. Moreover
Author: Patricia
How Much Process Development Is Enough Before GMP Manufacturing?
September 24, 2026
There is a point in almost every biologics program when process development starts raising an uncomfortable question: are we still improving the
Can Your CDMO Handle a Non Standard Protein?
September 8, 2026
Platform processes have transformed biologics manufacturing. They save development time, reduce uncertainty and allow CDMOs to build experience around repeatable workflows. For
Should Drug Substance and Fill & Finish Stay With the Same CDMO?
August 20, 2026
There is nothing inherently wrong with manufacturing Drug Substance at one site and filling Drug Product somewhere else. The biopharma industry has
Small GMP Batches: Why Bigger Is Not Always Better in Biologics Manufacturing
August 6, 2026
Bioreactor capacity is one of the first numbers biotech teams see when comparing CDMOs. 200 L. 500 L. 2,000 L. Sometimes considerably
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
Is Your Cell Line the Right Choice for You? A Practical Q&A
July 13, 2026
Choosing a strain or cell line is one of those decisions that looks technical at first, but can become surprisingly strategic later.
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…