Built around large molecule biologic formulation challenges
Large molecule biologic injectables often involve sensitive molecules that can be vulnerable to aggregation, degradation, interfacial stress and excipient-related instability. For formulation teams, confidence depends on more than selecting a surfactant. It depends on understanding how excipient quality, impurity control, surfactant strategy and formulation support can help protect biologic stability from development through to delivery.
Croda brings together high purity excipient technologies, Super Refined™ purification and formulation expertise to help support large molecule injectable development across oncology and immunology applications.
Supporting stability where biologics are under pressure
Biologic formulations can be sensitive to multiple stress factors, including oxidation, hydrolysis, agitation, reconstitution stress, interfacial exposure and residual host-cell protein activity.
Croda’s Super Refined™ excipient technologies are designed to reduce impurities and support more consistent excipient performance, helping formulation teams build a cleaner foundation for sensitive biologic injectables. For large molecule formulation development, this can help support:
- Biologic stability
- Reduced aggregation risk
- Improved surfactant performance
- Stronger excipient consistency
- Greater confidence in formulation performance over time.
Data-led support for biologic formulation decisions
Croda has generated formulation data across large molecule biologic APIs including Rituximab, Trastuzumab, Bevacizumab, Adalimumab and Ustekinumab. This data helps show how high purity surfactants, Super Refined™ excipients and BioXPro™ amino acids can support biologic stability, reduce formulation risk and help teams make more informed excipient choices. For teams working with complex biologics, this creates a clearer link between formulation challenge, excipient strategy and development confidence.
Helping address surfactant degradation and interfacial stress
Excipient combinations for large molecule biologic APIs
Some large molecule formulations require carefully selected combinations of surfactants, buffers, stabilisers and high purity excipients. The right combination can help support biologic stability, reduce aggregation risk and improve formulation robustness. Croda can help formulation teams explore excipient combinations for biologic APIs including:
Trastuzumab Potential combinations include Super Refined™ Polysorbate 20, BioXPro™ Histidine, BioXPro™ Histidine Hydrochloride and Super Refined™ Benzyl Alcohol.
Bevacizumab Potential combinations include Super Refined™ Polysorbate 20 and Super Refined™ Polysorbate 80.
Adalimumab Potential combinations include Super Refined™ Polysorbate 80, BioXPro™ Histidine Hydrochloride and BioXPro™ Arginine Hydrochloride.
Ustekinumab Potential combinations include Super Refined™ Polysorbate 80, BioXPro™ Histidine and BioXPro™ Histidine Hydrochloride.