Science / Technology
Insmed has an experienced team with a proven ability to develop recombinant protein products. Our staff have a wealth of experience and training with more than 400 total years of biotech and pharmaceutical experience working with over 40 companies in the biotechnology industry.
While manufacturing a follow-on biologic product is complex, developing a stable, consistent cell line is even more challenging and requires extensive knowledge and experience.
Insmed's cell line development capability is based on the team's specialization in protein expression. Insmed scientists have developed the systems for producing high levels of recombinant proteins in E. coli, yeast, and mammalian cell lines. In addition to their expertise in cell line development, the Insmed team has created a highly efficient and productive protein development process with the following integrated components:
Process development
Insmed's structured approach relies on the optimization of process conditions for high process yield and high levels of purity, optimization of expression levels, optimization of protein folding (when appropriate), and selection and optimization of scalable chromatographic purification methods.
Formulation development
Insmed has the capability and experience in the development of formulation conditions for product stability, including liquid and lyophilized vials, pre-filled syringe, and cartridge presentations.
Analytical development-Using state-of-the-art methods, Insmed develops methods to:
- Assure the protein production process is always in a state of control
- Verify the quality of the output product from manufacturing on an ongoing basis (quality control)
- Perform thorough product characterization and comparability
Experience in Developing FDA-Approved Biologics
Insmed employees have significant protein process development and manufacturing experience with more than 15 licensed products including Betaseron, Epogen, Humatrope, and Neulasta. Insmed has developed, commercialized, and received FDA approval for IPLEX, an insulin-like growth factor biologic product.
As part of its overall approach to protein development, Insmed performs process characterization and process validation in order to:
- Understand the function and purpose of each step in the protein development process
- Understand the effects of process inputs on process outputs for each step
- Provide consistent yield and purity at all operating ranges
- Set the process validation acceptance
