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Updates
Insights, updates and perspectives from the 53Biologics team on biologics development and manufacturing.
Engineering Batches: The Run That Can Save Your GMP Campaign
An engineering batch can be difficult to defend internally. It uses manufacturing time. It consumes raw materials. And it costs money. Moreover and unlike
How Much Process Development Is Enough Before GMP Manufacturing?
There is a point in almost every biologics program when process development starts raising an uncomfortable question: are we still improving the process, or
Can Your CDMO Handle a Non Standard Protein?
Platform processes have transformed biologics manufacturing. They save development time, reduce uncertainty and allow CDMOs to build experience around repeatable workflows. For many molecules,
Should Drug Substance and Fill & Finish Stay With the Same CDMO?
There is nothing inherently wrong with manufacturing Drug Substance at one site and filling Drug Product somewhere else. The biopharma industry has worked this
Small GMP Batches: Why Bigger Is Not Always Better in Biologics Manufacturing
Bioreactor capacity is one of the first numbers biotech teams see when comparing CDMOs. 200 L. 500 L. 2,000 L. Sometimes considerably more. It
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