Biosimilars and Interchangeable Biologics: Tactical Elements

Biosimilars and Interchangeable Biologics

Tactical Elements
Edition number: 1
Publisher: CRC Press
Date of Publication:
Normal price:

Publisher's listprice:
GBP 44.99
Estimated price in HUF:
21 730 HUF (20 695 HUF + 5% VAT)
Why estimated?
Your price:

19 557 (18 626 HUF + 5% VAT )
discount is: 10% (approx 2 173 HUF off)
The discount is only available for 'Alert of Favourite Topics' newsletter recipients.
Click here to subscribe.

Estimated delivery time: In stock at the publisher, but not at Prospero's office. Delivery time approx. 3-5 weeks.
Not in stock at Prospero.
Can't you provide more accurate information?

Product details:

No. of pages:624 pages
Size:280x210 mm
Weight:2680 g
Short description:

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

Long description:

What?s the Deal with Biosimilars?

Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.

Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.

Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.



Table of Contents:

Structural and Functional Elements. Immunogenicity Considerations. Product Development Strategies. Stability and Formulation Considerations. Biosimilarity Tetrahedron. Recombinant Expression Systems. Upstream Systems Optimization. Downstream Systems Optimization. Single-Use Manufacturing Systems (SUMS). Commercial Manufacturing Overview. Outsourcing Considerations. Appendix: Glossary of Terms.