Beyond our experience with conventional formulations (liquid, frozen or lyophilized), Legacy BioDesign LLC can provide the following specialized expertise:

High Concentration Formulations. We have a well-developed, rational strategy for identifying the formulation conditions most likely to lead to high solubility and low viscosity for peptides and proteins. Design of these types of formulations make use of our unique approach to solubility optimization. In addition, we are the only company that has rational plan for developing stable liquid formulations using any concentration of a active biopharmaceutical ingredient.

Vaccine Development. Many contract organizations have not developed vaccine formulations, but Legacy has, including cell-, protein-, and DNA-based vaccines. Legacy has access to a variety of experts in vaccine and cell preservation to support these efforts.

Biophysical Characterization. One of the strengths of Legacy BioDesign is the expertise in biophysical characterization of complex biomolecules. We can use this expertise and capability to develop solid preformulation packages for regulatory filings for your product.

Process Analytical Technologies (PAT).

Protein Stability during Bioprocessing.

Terminal Sterilization.  

Controlled Release Drug Delivery Systems. We have worked with polymeric microspheres, biocompatible gels, liposomes, suspensions, and devices. Within these controlled release systems, we have incorporated antibiotics, chemotherapies, immune modulators, peptides, proteins, and DNA. Similarly, we have developed formulations of biopharmaceuticals for use in sophisticated delivery devices, so we can help you with combination products as well.

Drug Product Production. We have two excellent fill/finish facilities as part of the Legacy network.

Immobilized Proteins. We have worked on issues of protein immobilization and maintenance of the stability of these products.