CHEMISTRY MANUFACTURING CONTROLS EXPERTISE
Historically a softgel company, Banner Life Sciences™ is branching out to utilize multiple platforms and capabilities, including tablets and sterile injectables, to grow and enhance our product portfolio. The group has expertise in controlled-release, delayed-release, sustained-release capsules and tablets, solubilization, stability enhancement, taste masking, and tailoring formulations to desired PK profiles. With unbridled innovation, our scientists are able and encouraged to explore any technique and technologies to achieve their goals.
The team is comprised of top-level scientists, with experience in reformulation, formulation, process development, scale-up, and design of experiments. Based on the characteristics of the selected active pharmaceutical ingredient, our formulators are able to devise a development plan to achieve the desired target product profile and performance. Designing products with the patient in mind, our end-to-end development process strictly adheres to the principles of quality by design to ensure the highest level of quality and consistency.
The analytical-development team has strong expertise in method development and validation, ranging from basic wet chemistry to complex LC/MS methodology. All analytical methods and stability programs are developed to meet regulatory requirements for both drug substance and drug product characterization, as well as all appropriate requirements in accordance with the FDA, USP, FDA, and ICH.