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Biologic Clinical & Material Compatibility

Life Sciences / CDMO/CRO Services / Biologics / Formulation Development / Clinical and Material Compatibility

In-Use Clinical Compatibility

Test the compatibility of your materials and equipment with your biotherapeutic to ensure dosing and limit immunogenicity concerns prior to patient administration. Our team addresses many factors that impact in-use compatibility, such as varying materials used in IV bags, tubing, syringes, and filters. Other factors, such as chemical composition and manufacturing processes, may also elicit different chemical and physical interactions with your biotherapeutic, resulting in possible destabilization.

Any changes to clinical drug preparation and administration guidelines within a pharmacy manual must also be tested to ensure product quality and dosing. While these adjustments improve clinical safety, they also make preparation more complex and reinforce the need for assessing all components. When administration procedures, handling instructions or required equipment call for revision, such as the implementation of a closed system transfer device (CSTD), our team helps address and verify any resulting outcomes.

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Contaminant Identification

Process-related unknowns and contaminants have the potential to decrease chemical and physical stability in your bulk drug substance or final product. We help identify and reduce these factors to ensure active stability and lot consistency. Our studies assess the stability of your biologic with known contact materials and contaminants as well as provide the analytical tools to identify and reduce residual contaminants. These contaminants often include metals, silicone oil, oxidizers, plasticizers, antifoam agents, and host cell proteins.

Integrated Laboratory Services  

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.