Formulation Development

Biopharmaceutical formulation development focuses on creating a stable and effective formulation for biologic drugs, ensuring their stability and efficacy throughout production, storage, and administration. This process requires a deep understanding of the biologic molecule’s properties, such as size, charge, and hydrophobicity. It involves several key steps, including pre-formulation studies, formulation optimization, and stability testing.

By integrating formulation and process development early in drug development, we minimize the risk of costly reformulations in later phases. Our advanced technologies and high-throughput equipment enhance our ability to develop robust formulations efficiently.

Key Considerations in Biologic Drug Formulation

Formulation strategies must address the unique characteristics of biologic molecules to ensure their stability, efficacy, and safety. Critical factors include:

• Molecular Stability: Evaluating the molecule’s behavior under different temperatures, pH levels, and salt concentrations to prevent degradation.
• Minimizing Aggregation and Viscosity: Optimizing formulation components to reduce protein aggregation and maintain solution stability, preserving drug quality.
• Patient-Centric Approaches: Selecting appropriate dosage forms (liquids, injectables, or other formats) to enhance patient compliance and treatment outcomes.
• Regulatory Compliance: Using approved excipients to protect active ingredients, maintain potency, and meet regulatory standards.

Our team specializes in designing in designing an appropriate development strategy, considering the commercial application and route of administration, using regulatory approved reagents and excipients, to target and control specific degradation pathways and protect Critical Quality Attributes.

Molecules We Work With

Rodon has extensive experience in developing formulations for a wide range of biologic molecules, including monoclonal antibodies (mAbs), multispecific antibodies, recombinant proteins, fusion proteins, vaccine antigens, enzymes, cytokines, and growth factors, among others. Each of these molecules presents unique formulation challenges, such as stability concerns, aggregation tendencies, and delivery requirements. Our expertise allows us to tailor formulations that maximize drug stability, bioavailability, and manufacturability while ensuring compliance with industry standards.

Rodon’s Formulation Development Expertise

The approach taken by Rodon is based on first establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability of the protein in early preformulation studies. This includes stress studies to promote degradation which allows for a clearer selection of reagents and excipients for further formulation development and identification of stability indicating methods. We employ Design of Experiments (DOE) methodologies to evaluate multiple factors simultaneously, ensuring a data-driven approach to stability optimization.

To support formulation development, we offer a comprehensive suite of analytical methods, including:

• Bioassays for potency assessment, utilizing minimal sample quantities when applicable.
• Biophysical characterization techniques to rapidly determine optimal formulation conditions.
• Stability-indicating methods for precise monitoring of drug integrity.

Get in Touch with Us

Are you ready to embark on your biologics formulation development journey with a partner who understands the intricacies of biopharmaceutical formulation development? Contact us today to learn how our expertise and advanced technologies can help you achieve successful drug formulation and manufacturing.