Since our inception, we have conducted formulation development work for a number of clients, covering a wide range of proteins. They 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 this wide range of proteins, we have developed liquid dosage forms, frozen solutions, and lyophilized products. Legacy is equipped to develop all types of lyophilized (freeze-dried) protein formulations. Once a dried formulation has been developed, we can also work toward identifying a lyophilization cycle that is intended to provide pharmaceutical elegance and efficiency as well as ensure the stability of the drug product. These cycles have been effectively transferred to CMOs and other manufacturing sites.

Please note that Legacy has experience with other types of drying methods as well, such as spray-drying, spray freeze-drying, and supercritical fluid drying.

In addition, Legacy has experience formulating proteins for a variety of parenteral and non-parenteral applications, including

• Oral/Peroral Dosage Forms
  

  Tablets

  Solutions

  Capsules

  Suspensions

  
  
• Inhalation (Pulmonary) Products
  

  Dry Powder Formulations

  Liquid Formulations

  Microspheres

  
  
• Nasal Dosage Forms
  
  
• Ophthalmic Dosage Forms (topical, intraocular)
  
  
• Transdermal/Topical Dosage Forms
  
  
• Otic Dosage Forms
  
  
• Buccal Dosage Forms
  
  
• Implantable Devices (pumps, stents)
  
  
• Controlled Release Dosage Forms, including microspheres and nanoparticles

Finally, in many cases, Legacy has the skill and experience to develop formulations that do not infringe existing patents. At the same time, we often can develop novel compositions that could lead to additional intellectual property (IP) for our clients. While this is an important difference in how we approach formulation development of biosimilars, it can also be important for new chemical entities as well.