Specialized Experience
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.
- 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 four 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.
Protein Stability During Bioprocessing
Another area where Legacy has some unique expertise is in identifying protein instabilities during processing. Using multivariate statistical methods (such as Principal Component Analysis and Projection to Latent Structures), we are able to determine the potential source of the damage to the protein. Then an efficient strategy for diminishing or retarding protein degradation can be developed and implemented. We are able to design and conduct studies on the potential adverse effects of shear, agitation, filtration and other stresses. Beginning in 2007, there will be a presentation on this topic in the three-day short course we present on peptide and protein stabilization and formulation, offered through the European Continuing Education College.
Using g-Irradiation One of the ultimate goals of biopharmaceutical product development is to provide a safe and effective product. Towards that end, there has been a long-standing interest in terminal sterilization, using methods that would inactivate pathogens of all types, including non-enveloped viruses. While g-irradiation has the potential to inactivate all types of pathogens, it also can cause substantial damage to proteins and peptides. In partnership with another company, we have developed formulation strategies that reduce the level of damage exhibited by proteins, even at relatively high doses of radiation. We would welcome the opportunity to evaluate g-irradiation as a potential terminal sterilization step for your biopharmaceutical or combination product.