Formulation and Drug Product Development
Comprehensive support for your biopharmaceutical’s formulation and product development.
Finishing Your Development Journey with Finesse
The uniqueness of each biologic drug product often demands a specially tailored formula, as there are numerous variables that can impact stability, potency, and delivery. Our experienced team of formulation development experts excel at fine-tuning the composition of an array of biopharmaceuticals, encompassing therapeutic proteins, enzymes, monoclonal antibodies, and bispecific antibodies.
As you work with us, we will walk you through pre-formulation studies to examine the biophysical properties of your molecule, its thermal stability and aggregate formation in response to formulation and storage conditions. During drug product development, we will evaluate your molecule under a range of buffer conditions, temperatures, shear force, pH levels, salt concentrations, as well as excipients that help stabilize your molecule or aid in manufacturing or drug delivery. These insights will allow us to select the most optimal, robust drug product formulation for the molecule’s intended therapeutic use, and maintain its stability, conformation and efficacy during production, shipping, and storage for the desired shelf life.
Our Strengths
Tanvex’s formulation and drug product development strengths are rooted in our team’s scientific acumen which enables us to rapidly design, test, and optimize biopharmaceutical development and manufacturing. With a commitment to innovation and efficiency, Tanvex empowers clients to navigate the complex path from concept to market with precision and speed.
- QbD approach and high throughput methodology that expedite the pre-formulation screening process, allowing for quick iterations and optimization.
- Streamlined drug product development approach ensures swift design and testing of formulations, reducing development timelines while maintaining quality.
- Focus on optimization guarantees the creation of stable, effective, and safe pharmaceutical products that stand up to regulatory scrutiny and patient expectations
Our Capabilities
With a focus on innovation and optimization, Tanvex crafts tailored solutions that ensure the creation of safe, effective, and stable biopharmaceutical products.
- High throughput pre-formulation screening
- Drug product formulation development
- Biophysical characterization
- Thermal stability assessment
- Excipient compatibility studies
- Pooling and mixing characterization
- Filter integrity assessment (Vmax, flush volume, Bacterial Retention Support)
- Filtration process characterization
- Filling process characterization and assessment
- Filter comparability and compatibility assessment
- Extractable and leachable assessment of manufacturing production components
- DP package selection, assessment, compatibility and testing (functional studies for syringes using Instron, photostability, CCIT)
- Shipping assessment and testing
- Regulatory drafting and audit support
- Administration / IV bag compatibility
