Since our inception, we have engaged in formulation development endeavors on behalf of numerous clients around the world, covering a wide range of protein types, which include:

• Monoclonal Antibodies

• Antibody Fragments

• Antibody-Drug Conjugates

• Cytokines (Interleukins & Interferons)

• PEGylated Proteins

• Chimeric Proteins

• Fusion Proteins

• Plasma-derived proteins, including blood clotting factors

• Industrial Enzymes

For these various proteins, we have developed stable liquid formulations, frozen solutions, and lyophilized products. Legacy is well-equipped to develop a comprehensive range of lyophilized (freeze-dried) protein formulations. Following the development of a dried formulation, we are proficient in identifying a lyophilization cycle aimed at achieving pharmaceutical refinement and efficiency while concurrently ensuring the stability of the drug product. These meticulously devised cycles have been efficiently transferred to Contract and Development Manufacturing Organizations (CDMOs) and other manufacturing facilities.

Furthermore, Legacy’s expertise extends to formulating proteins for various parenteral and non-parenteral applications, which include:

• Oral/Peroral Dosage Forms

• Inhalation (Pulmonary) Products

• Dry Powder Formulations

• Liquid Formulations

• Nasal Dosage Forms

• Ophthalmic Dosage Forms (Topical & Intraocular)

• Transdermal/Topical Dosage Forms

• Buccal Dosage Forms

• Implantable Devices, Including on Body Injectors

It is worth emphasizing that Legacy possesses the proficiency and experience to develop formulations that respect existing patents. We also endeavor to perform formulation studies in such a detailed manner that we can generate IP for our clients as well. In many instances, we have been successful in contributing to their existing patent portfolio. To date, Legacy scientists have been named as inventors on over 50 US patents on behalf of our clients.