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 extensive experience with a wide range of therapeutic peptides and proteins.
- Vaccine Development. Many contract organizations have not developed vaccine formulations, but Legacy has, including multivalent, peptide-, conjugate-, and DNA-based vaccines.
- Lyophilization Development. In addition to developing stable and commercially viable lyophilized formulations for clients, we also believe that it is important to develop lyophilization cycles that are as effective and as efficient as possible for the selected formulation. Therefore, we also offer lyo cycle development as part of our integrated services for dried products.
- 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.
- Immobilized Proteins. We have worked on issues of protein immobilization and maintenance of the stability of these products.
- Co-Formulation. Legacy has experience with co-formulation of two or more peptides or proteins, including mixtures of monoclonal antibodies.
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. In many of our short courses there is a presentation on this topic.
Using γ-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 γ-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 γ-irradiation as a potential terminal sterilization step for your biopharmaceutical or combination product.