How to choose a CDMO for biologics
Choosing a biologics CDMO is mostly a matter of matching a site to your molecule, your stage, and where the program is going next. Write those down before you send the first enquiry.
Start with the molecule
Say what you are making and how. An antibody made in Chinese hamster ovary cells needs different equipment and experience from a protein made in bacteria, an antibody-drug conjugate, or a viral vector. Ask each site which products like yours it has made, at which site, and at what stage.
Match the stage and the scale
Material for toxicology studies and early trials can come from small batches. Late trials and commercial supply need larger and more frequent batches. Ask what bioreactor scales the specific site runs, whether they are single-use or stainless steel, and whether your process could stay at that site as demand grows. A second technology transfer later costs time, so it is worth knowing early whether you would need one.
Drug substance and drug product
Drug substance is the purified protein. Drug product is the filled vial, syringe, or freeze-dried form. Some CDMOs do both, sometimes at different sites. Using one partner means fewer handoffs. Using two lets you pick the stronger site for each step. Either can work, but decide early who is responsible for the shipment between them.
Development and analytics
Ask what development work the site does in house: cell line development, upstream and downstream process development, formulation, and analytical method development and characterization. Biologics depend on their analytical methods, so ask who develops them, who validates them, and where release testing happens.
Who owns what
Agree who owns the cell line, the process, and the data before work starts. Some CDMOs offer their own expression system or cell line. Ask what license terms apply if you later move manufacturing elsewhere or sell the product commercially.
Quality record
Ask for the inspection history of the site that will make your product, not the company as a whole. Public records help. In the United States, the Food and Drug Administration publishes warning letters and inspection classifications. In Europe, the EudraGMDP database lists manufacturing authorizations, good manufacturing practice certificates, and statements of non-compliance. Plan your own quality audit before you sign.
Capacity and terms
Ask when the next manufacturing slot is open, how far ahead slots are booked, and what happens if a batch fails or you need to move a date. Read the cancellation and postponement terms closely.
Using the biologics list
Use the biologics manufacturing list to find candidate sites, then ask the questions above of each one.