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Biosimilars and Interchangeable Biologics: Tactical Elements
Even very established companies have made mistakes when developing biosimilar products. For example, not appreciating future threats to intellectual property caused a biosimilar product development plan to fail after millions were spent. Additional pitfalls include not anticipating the next line of improved products, better formulations, deliver
| Author(s) | By Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, Chicago, Illinois, USA). |
|---|---|
| Publisher | Taylor & Francis Ltd |
| Format | Paperback / softback |
| Pages | 624 |
| Published in | United Kingdom |
| Published | 2 Oct 2023 |
| Availability | Not yet available |
Even very established companies have made mistakes when developing biosimilar products. For example, not appreciating future threats to intellectual property caused a biosimilar product development plan to fail after millions were spent. Additional pitfalls include not anticipating the next line of improved products, better formulations, deliver
Structural and Functional Elements. Immunogenicity Considerations. Product Development Strategies. Stability and Formulation Considerations. Biosimilarity Tetrahedron. Recombinant Expression Systems. Upstream Systems Optimization. Downstream Systems Optim
Sarfaraz K. Niazi, PhD, is the founding executive chairman of Therapeutic Proteins International LLC, a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics, headquartered in Chicago. Dr. Niazi began his
