Formulation & Development

Scientist conducting testing in protected area

SCIENTIFIC & TECHNICAL EXPERTISE FOR ADEPT PROBLEM SOLVING

In our decades of partnership with pharmaceutical and biotechnology companies, we have used our scientific and technical expertise to solve a broad range of issues that come with product formulation and development. These include questions related to dosage forms (solution, suspension, freeze-dried), reformulation, drug stability, solubility, chemical degradation, component compatibility, leachables and extractables, and precipitation. We can also assess delivery options and delivery option product compatibility. Our team is equipped with state-of-the-art instrumentation and equipment.

Scientists in conversation

INDUSTRYWIDE COLLABORATION FOR CONTINUAL PROGRESS

Our scientists participate in consortia with industry groups and universities dedicated to advancing scientific and technical knowledge and contribute to standard-setting organizations such as USP and the Parenteral Drug Association. Whether your product is a biologic or a small molecule, standard or complex, clinical or commercial, our experts stand ready to develop and implement formulation decisions aimed at optimizing product quality throughout manufacturing.

EXPLORE THESE CRITICAL FORMULATION AND DEVELOPMENT CAPABILITIES:

RELATED RESOURCES

White Papers

Is Mannitol Hemihydrate Detrimental to Protein Stability Assessing Mannitol Crystallinity in Lyophilized Drug Products

Learn from the BioPharma Solutions team under what conditions MHH dehydrates and how the dehydration impacts protein stability.

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White Papers

Vial Breakage During Lyophilization

Learn more from the BioPharma Solutions team on the Root Causes and Mitigation Strategy for Vial Breakage during Lyophilization.

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White Papers

Importance of Assessing Mannitol Crystallinity in Lyophilized Drug Products

When mannitol is used as an excipient in a lyophilized drug product, assessing its crystallinity is important because drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

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