Find and compare companies providing Drug Substance (CDMO/CRO) services for:
Biologics

A biologics CDMO develops and manufactures biologic drug substance such as monoclonal antibodies, recombinant proteins, or enzymes. Services include cell line development, upstream processing, purification, and GMP release testing.

Biologics require living systems and complex purification, while small molecules rely on chemical synthesis. Biologic CDMO services emphasize cell culture, viral clearance, and protein characterization.

Include molecule type, expression system, target titer or yield, batch size expectations, and target markets. Add requirements for viral safety, analytics, and any platform process preferences.

Many biologic CDMOs offer cell line development and clone selection, but the depth varies. Confirm timelines and ownership of cell line documentation.

Typical steps include clarification, chromatography, viral inactivation or filtration, ultrafiltration, and formulation buffer exchange. The exact sequence depends on molecule type and impurities.

CDMOs implement viral clearance studies, filtration steps, and robust monitoring of cell banks. Ask for validated viral safety data relevant to your expression system.

Biologic scale ranges from small clinical batches to large commercial bioreactor campaigns. Share target volumes and future demand to ensure capacity alignment.

Yes, most offer extensive analytics such as potency assays, purity, glycosylation profiling, and stability studies. Clarify which methods are in-house versus outsourced.

Confirm GMP inspection history, quality system maturity, and track record with similar biologics. Ensure the facility supports your target regulatory markets.

Pitfalls include misaligned cell line transfer plans, incomplete analytical methods, and underestimating process variability. Early comparability and robust analytics reduce risk.

Many biotech CDMOs provide integrated development and GMP manufacturing. Validate that the same team can scale the process and support tech transfer.

Timelines depend on cell line maturity and platform processes. Early-stage programs may need additional development cycles for productivity and purification optimization.

Many facilities use single-use systems for flexibility and reduced cleaning validation. Confirm volume limits and compatibility with your process.

Filter by region, scale, and services, then compare experience with your molecule class and analytical requirements. Shortlist partners with validated viral clearance capability.