Frontage’s CMC portfolio of services spans pre-formulation, drug product formulation development, analytical method development and validation, GLP batches, GMP clinical trial materials (manufacturing, labeling, packaging, and distribution), scale up, pilot and pivotal/registration batches, and commercial manufacturing (to be ready Q3 2024).

Our formulation development experience and capabilities cover a wide range of dosage forms for IND, NDA, ANDA and 505(b)(2) filings.

Nanoemulsion has the potential to overcome several disadvantages in drug formulation. Nanoemulsions are nano-sized emulsions that can improve the bioavailability of drug molecules via various routes of administration. The development of nanoemulsion formulation is a challenging and lengthy process. Selecting components such as oil phase, surfactant, an optimum oil-to-surfactant ratio, and ideal process parameters are critical for developing a stable nanoemulsion. Development becomes more complicated when a drug molecule is sensitive to a variety of factors. This webinar discusses, with a case study, a nanoemulsion development process using a microfluidizer, and factors to consider while developing a sterile ophthalmic nanoemulsion formulation for a light, oxidation, and heat-sensitive molecule.

Gene therapy holds the promise to transform medicine and creates options for patients who are living with incurable diseases. The industry has been booming in the last 20 years. Before a gene therapy product can be used in humans, the product must be tested for safety and effectiveness. This webinar focuses on the introduction of three critical test methods: AUC, Infectivity and RCL assays. Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.