Formulation of Other Therapeutics
In addition to our extensive experience in peptide and protein formulation, we have also been involved in formulating a wide range of biotherapeutics, including products for all manner of parenteral delivery (subcutaneous, intramuscular, intrathecal, intravitreal, intravenous, intra-articular) and for non-parenteral delivery (oral, nasal, pulmonary, transdermal, topical) as well. These efforts have included:
Recombinant Vaccines: We have formulated recombinant vaccines, spanning both multi-valent and conjugate variants, and have evaluated the impact of a number of different adjuvants on vaccine stability.
Nucleic Acid-Based Therapies: Our proficiency extends to formulating nucleic acid-based therapies, including aptamers, ribozymes, non-viral DNA plasmids, CpG-based adjuvant and small interfering RNAs (siRNAs).
Multi-Protein Mixtures: We have significant experience in the co-formulation of multiple protein and peptide mixtures intended for both prophylactic and therapeutic uses. This includes the concurrent formulation of monoclonal antibodies. As part of these efforts, we have developed analytical methods that allow for monitoring the stability of the individual components.
PEGylated and Modified Peptides and Proteins: Legacy has experience in formulating peptides and proteins that have been chemically modified, including PEGylated materials, lipidated peptides, polypeptides modified with fatty acids, and various alkylated peptide products. We have published a review on the formulation and handling of PEGylated proteins.
“Product Development Issues with PEGylated Proteins”, Robert W. Payne, Brian M. Murphy, and Mark Cornell Manning, Pharm. Dev. Technol. 2011, 16: 423-440.
Antibiotics and Anticancer Compounds: We have contributed our expertise to the formulation of small molecules, such as antibiotics and anticancer compounds. This has included products intended for human as well as veterinary applications.