Research & Development

Full physical and chemical characterization of Banner finished products includes Dissolution Evaluation for QC and/or In Vitro/In Vivo Correlation (IVIVC).

Pharmaceutical development demands compliant analytical methods for regulatory submission. With access to state-of-the-art instrumentation our scientists can solve complex analytical problems. We develop and validate analytical methods according to current regulatory standards. Thorough Quality Assurance auditing ensures the quality of the results.

When higher sensitivity, specificity and throughput are needed, Banner R&D and QC laboratories use a Tandem Liquid Chromatography/Triple Quadruple Mass Spectrometer for development, validation, transfer of analytical methods and sample analyses.

Our creative, experienced and resourceful R&D organization (click to view entire team) has a proven record of developing breakthrough technological applications of gelatin based dosage forms as demonstrated by our strong portfolio of intellectual property and unique proprietary products. Many of the top 10 US pharmaceutical companies have chosen to partner with Banner to develop gelatin based formulations for both their Rx and OTC compounds. Our flexibility, rapid turnaround and customer focus also make us a preferred partner for smaller specialty pharmaceutical companies. As an industry leader in softgel technology, Banner offers exceptional expertise in gelatin-based drug delivery systems to help create innovative products and line extensions for new as well as previously marketed drugs.

For several decades we have been developing and manufacturing billions of units of softgel and Soflet® GelCaps products that are distributed through our marketing partners worldwide. Our mission is to create and market superior health care products to serve our global community. To realize this goal, our global R&D team includes more than 80 professionals working in state-of-the-art laboratories in our U.S. headquarters as well as in Europe and Mexico. The R&D team includes more than 17 Ph.D. level scientists. The primary R&D group based at our headquarters in High Point, North Carolina, USA integrates all critical functional areas for successful product development.

Customized work processes are used in new product development which enable the various R&D departments of Clinical Supplies, Analytical Development, Formulations Development, Clinical and Regulatory Affairs and Project Management Team to work seamlessly together with Quality Assurance to successfully develop several prescription, over-the-counter (OTC) and nutritional products based upon our innovative soft gelatin based oral drug delivery platforms. Banner R&D maintains a consistent presence at various industry symposia and regularly produces scientific literature in a variety of journals and publications.

Full physical and chemical characterization of Banner finished products includes Dissolution Evaluation for QC and/or In Vitro/In Vivo Correlation (IVIVC).

Banner's R&D team has conducted campaigns from proof-of-concept to full scale manufacturing in our modern and well-equipped pharmaceutical and material science laboratories. A wide range of drug delivery platforms is developed with equipment such as the Freeze Dryer.

Technical Innovations

Softgel capsule manufacturing offers major advantages in the sequestered handling of hazardous drugs in liquid form as opposed to tablets and other solid oral dosage forms that may result in dust exposure and contamination of personnel and environment. Our highly trained employees have the capability to work with different classes of potent compounds, including cytotoxic, immunosuppressant, teratogenic, and carcinogenic compounds. Our Potent Compounding Suite is designed to ensure complete safety and protection of both personnel and environment through its independent and isolated systems featuring complete air-lock entry and an isolation chamber. Our Applications Laboratory enables scientists to test manufacture a variety of formulations while utilizing very small amounts of active ingredients.

This unique laboratory allows for bench-scale softgel and Soflet Gelcap batches to be made quickly and cost effectively, thereby speeding up time to market. The encapsulation machine is similar in mode of operation to our production machines, allowing the development of robust processes during development that subsequently enjoy a high likelihood of success in production. This advanced lab is well suited for feasibility studies, which can be implemented at our High Point facility at a fraction of the cost of full-size development runs.

Patents

We are committed to the development and use of Banner's intellectual property for the benefit of our customers. We have over 20 patents to our name, and several additional ones pending. Some of our granted patents include:

  • US 6,949,256, "Non-Gelatin Capsule Shell Formulation"
  • US 6,482,516, "Enrobed Tablet"
  • US 6,258,380, "Chewable Soft Capsule"
  • US 6,251,426, "Ibuprofen Containing Softgels"
  • US 6,214,376, "Non-Gelatin Substitutes for Oral Delivery Capsules, Their Composition, and Process of Manufacture"
  • US 6,193,999, "Gum Acacia-Substituted Soft Gelatin Capsules"
  • US RE39,347, "Multiple Layered Softgel"