Biologics Formulations
Roquette provides integrated solutions designed to address key challenges in biologics formulation, helping scientists and manufacturers ensure product stability, efficacy, and compliance. Each excipient plays a critical role in overcoming formulation and process hurdles commonly encountered with protein-based drug products.
Optimize Biologics Formulations with Roquette’s Advanced Excipients
Roquette offers a versatile portfolio of GMP, compendia-grade excipients developed to ensure the stability, safety, and performance of final biopharmaceutical formulations. Whether protecting sensitive biologics from degradation or maintaining isotonicity and integrity during processing, Roquette’s excipients for biologics formulation deliver consistent reliability for injectable and lyophilized formats.
With proven solutions such as KLEPTOSE® HPB Biopharma and HP Biopharma hydroxypropyl beta-cyclodextrin low endotoxin grades, and NEOSORB® sorbitol, PEARLITOL® mannitol, and LYCADEX® dextrose monohydrate Biopharma grades, Roquette supports formulation scientists in achieving robust stability, process compatibility, and global regulatory confidence.
Addressing Key Challenges in Biologics Formulation
Comprehensive Stabilization of Biologics
Roquette’s excipients deliver broad protection against thermal, light/UV, agitation, and formulation stress, helping preserve the three-dimensional structure of sensitive biomolecules. By maintaining stability under various process and storage conditions, these excipients help extend shelf life and support reproducibility in biopharmaceutical production.
Mitigating Aggregation and Instability
Protein aggregation and particle formation remain key challenges in biologics formulation. KLEPTOSE® HPB and HP hydroxypropyl beta-cyclodextrin stabilizers mitigate these effects by reducing molecular interactions that lead to instability. Combined with polyol-based stabilizers such as sorbitol and mannitol, Roquette’s portfolio helps maintain protein solubility and activity throughout the formulation process.
Supporting Lyophilized and Injectable Formats
Formulating for lyophilized and injectable biologics requires a precise balance of bulking, isotonicity, and cryoprotection. Sorbitol, mannitol, and dextrose monohydrate Biopharma grades help protect biologics during freezing, drying, and reconstitution. These excipients enable consistent cake structure, rapid dissolution, and easy administration, ensuring product reliability from manufacturing through final use.
Regulatory Confidence and Global Compliance
All Roquette biopharma-grade excipients are produced under good manufacturing practice (GMP) conditions and listed in major global pharmacopeias, providing confidence for regulatory submissions worldwide. Each material is fully traceable and supported by comprehensive technical and quality documentation, ensuring regulatory alignment and market readiness across international territories.
Our Services and Expertise
Roquette supports formulation scientists and manufacturers through a combination of technical collaboration, regulatory expertise, and secure global supply, ensuring the reliability and performance of biopharmaceutical formulations from development through commercialization.
Through our scientific resources and dedicated Customer Technical Services (CTS), Roquette provides tailored formulation guidance and analytical insight. Scientists can collaborate directly with our experts to address stability challenges, optimize excipient selection, and refine lyophilization or reconstitution parameters. This technical partnership helps accelerate formulation development while maintaining scientific rigor and compliance with global standards.
All excipients are manufactured under GMP conditions with low endotoxin levels and full traceability, ensuring consistent product quality and safety. Roquette’s extensive regulatory support and documentation packages simplify market submissions and facilitate approval in multiple regions, offering confidence to both development and quality teams.
With a reliable and secure global supply chain, Roquette ensures continuity of supply for both clinical and large-scale commercial manufacturing. This end-to-end assurance, covering quality, regulatory compliance, and logistical dependability, enables customers to bring high-quality biologics formulations to market with confidence.
Excipients for Stability, Cryoprotection, and Isotonicity
Roquette’s excipients are designed to strengthen the integrity and performance of biopharmaceutical formulations, ensuring consistent stability and compatibility with process requirements. From cyclodextrins to polyols, each Roquette excipient contributes to maintaining protein stability and ensuring reliable drug performance. Explore the range of products that support biologics formulation success.
Our Applications
Biologics
Stabilizers, cryoprotectants, and process aids for safe, efficient biologic formulation and manufacturing.
Injectables, Dialysis and APIs
High-purity excipients ensuring biocompatibility and isotonicity in parenteral and dialysis applications.
Oral Dosage Solutions
Functional excipients improving flow, compressibility, solubility, and taste for tablets and capsules.