Prepare Your Drug Product with Process Development
Prepare your product for advancing into the clinic and beyond with our integrated approach to the drug development process. We help you develop downstream purification processes, repurification, UF/DF, compounding, and challenging formulation processes. Our approach focuses on gaining a deep molecular understanding of the API while maintaining a focus on the target product profile to ensure the process will be reproducible, scalable, and transferable.
Our experts develop biologic formulations and processes in a parallel, iterative manner to ensure consistent manufacturing and a reliable drug supply. Analytical methods further support formulation development and GMP testing activities, which are optimized and validated at the stage-appropriate time.
Once the formulation and process are established, our team characterizes the processes for manufacturing the final dosage form and the bulk formulation for scale-up and robustness. We then transfer these to the manufacturing facility. Finally, manufactured materials are tested for release and placed into long-term stability studies at one of our central GMP laboratories to support clinical trials and commercialization.
Biologics Development Support
Biologics process development relies on an integrated approach that considers the molecular and manufacturing constraints identified in your prior research and informs subsequent stages. By engaging our cross functional team, your program benefits from a cohesive point of view, proven experience, and a simplified pathway forward.
Develop your compound’s optimal drug product formulation within the boundaries informed by preformulation characterization data, such as solubility, stability parameters, and the target pH range. We take a comprehensive approach to addressing formulation challenges and preparing your compound for compatible processes.
Make a smooth transition into pivotal clinical phases with our process development services. With numerous variables at play, our integrated lab network provides a dynamic, responsive approach to unforeseen challenges. We carefully characterize the manufacturing processes for scale-up and robustness, then transfer these to one of our GMP facilities.
Manufacture your clinical supplies with our extensive GMP clinical supplies manufacturing capabilities. Our offerings span solids, semi-solids, and liquids, to orals, topicals, and injectables. In addition, we offer sterile facilities, controlled substances, and clinical packaging and kitting services for various dosage forms.
Targeted Process Development Services
Overcome poor water solubility barriers that prevent your drug product from achieving its full bioavailability potential. Our expert team offers spray drying for amorphous solid dispersions to optimize your drug’s efficacy. This advanced technique effectively removes crystallinity and maximizes soluble concentration at the site of absorption.
Prepare for advancing your biological drug substance or drug product to the next stage with downstream ultra filtration (UF) and diafiltration (DF) purification processes. Whether you require a one-off buffer exchange to support early-stage formulation development or a full-scale process development endeavor with transfer to GMP facilities, our team prepares your manufacturing and fill finish processes to optimize your drug product formulation.
Control the release of your biologic by coating your intermediate drug product with protective enteric coating. These coatings inhibit the release of the drug in low pH environments, where they are more vulnerable to degradation and agglomeration. Our team identifies the appropriate enteric coating for your biotherapeutic and prepares your processes to scale into commercial manufacturing.