Research and Markets: Therapeutic Protein Drug Products: Practical Approaches to Formulation in the Laboratory, Manufacturing, and the Clinic
Research and Markets (http://www.researchandmarkets.com/research/z32cst/therapeutic) has announced the addition of Woodhead Publishing Ltd's new book "Therapeutic Protein Drug Products: Practical approaches to formulation in the laboratory, manufacturing, and the clinic" to their offering.
Therapeutic Protein Drug Products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.
Key Topics Covered:
- Commercial therapeutic protein drug products
- A formulation method to improve the physical stability of macromolecular-based drug products
- Properties of protein formulations
- Material and process compatibility testing
- Compounding and filling: Drug substance to drug product
- Administration in the clinic
- Regulatory guidelines for the development of a biotechnology drug product.
For more information visit http://www.researchandmarkets.com/research/z32cst/therapeutic
Source: Woodhead Publishing Ltd