This book 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.

The book is primarily directed towards professionals within the biotechnology and pharmaceutical industries; it is also of interest to those in academia.

Price GBP  110.00,  Price USD  178.00,   Price EU  125.00

 Key features: 

• The book provides a list and description of commercially available therapeutic drug products and their formulations.
• The book provides a comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic.
• The book discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles.
• Recommendations are made as to how therapeutic proteins can be evaluated at the pilot scale prior to manufacturing, with an emphasis on material and process compatibility testing. The book provides a regulatory perspective on therapeutic protein formulation, specifically topics related to subvisible particles.

• Commercial therapeutic protein drug products (Brian K. Meyer and Mohammed Shameem) - introduction; lyophilized formulations; liquid formulations (monoclonal antibodies and IgG fusion proteins; proteins and peptides to 150 kDa); protein formulations for radiologic and diagnostic use; summary; references
• A formulation method to improve the physical stability of macromolecular-based drug products
• (Akhilesh Bhambhani, Santosh Thakkar, Sangeeta B. Joshi and C. Russell Middaugh) - introduction; common techniques used for the construction of EPDs (UV absorbtion spectroscopy; far-UV circular dichroism; fluorescence spectroscopy; pressure perturbation calorimetry; ultrasonic spectroscopy; red-edge excitation shift spectroscopy; time-correlated single photon counting; dynamic light scattering; miscellaneous techniques); the peptide drug pramlintine; monoclonal antibodies at low and high concentration; static vs. dynamic EPDs: a case study using a humanized immunoglobulin G1 (IgG1); conclusions and future studies; references
• Properties of protein formulations (Henryck Mach, Brian Meyer and Mohammed Shameem) - introduction; opalescence; color; phase separation; subvisible particles (analytical methods; immunogenicity; trends and challenges); references
• Material and process compatibility testing (Brian K. Meyer) - introduction; material compatibility (stainless steel and alloys; plastic and other polymers; tubing; glass; rubber closures; silicone oil, tungsten; hydrogen peroxide); process compatibility testing (filtration; pumping during manufacturing of drug substance; pumping during filling of drug product; mixing and stirring; photostability; shaking); antimicrobial preservative compatibility testing; references
• Compounding and filling (Brian K. Meyer and Louis Coless) -introduction; aseptic processing; bulk drug substance (manufacture of buffers; single-use (disposable) containers; reusable containers; frozen vs. 2-8°C storage; shipping); compounding of drug product (filtration; in-process assays); filling the drug product (container selection; stoppering; capping; inspection; shipping); references
• Administration in the clinic (Manoj Sharma, Chakravarthy Narasimhan and Mohammed Shameem) - introduction and background; diluents; components; construction materials; clinical dosing strategy: fixed volume versus fixed concentration; representative admixture concentration levels; exposure temperature and time; option of using syringes; analytical tests and acceptance criteria; sample preparation considerations; role of probe studies; bag overfill volume; pharmacy instructions; conclusions; references
• Regulatory guidelines for the development of a biotechnology drug product (Mark J. Waskiewicz) - introduction; ICH overview; Common Technical Document (CTD); drug product dossier (composition; pharmaceutical development; manufacturing; analytical control of drug product; reference standard; stability); regulatory considerations through the biotechnology product lifecycle (pre-clinical studies; early-phase clinical studies; late-phase clinical studies; commercial batches; life-cycle management); conclusions; notes