Continuous Manufacturing of Pharmaceuticals


Book Description

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.




Continuous Manufacturing for the Modernization of Pharmaceutical Production


Book Description

On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.




The College of Pharmacy


Book Description










Pharmacy Clinical Coordinator's Handbook


Book Description

Take Your Skills and Your Team to the Next Level Inside you’ll get real-life examples, sample forms, policies, procedures, checklists, and more for every aspect of your practice, including formulary management, communications, strategic planning, and staff development. Plus, tables and figures for everything from delegation flow and budget schedules to nonformulary drug requests and the SAFE Tool Scoring System. Get the advice, support, and tools you need to answer essential questions facing any clinical coordinator or manager: What are the key organizational relationships I need to develop to be successful? How can I best demonstrate the value that pharmacy provides to the healthcare team? How can I build and inspire a team to achieve high-quality patient outcomes? With multiple responsibilities and multiple priorities, how do I get started? What can I do to advance clinical pharmacy practice? As a clinical coordinator or clinical manager you are in a position to positively impact the lives of both your staff and the patients you serve every day. With the Pharmacy Clinical Coordinators Handbook you can now develop the vision and strategy you need to succeed in this essential and demanding position.




Pharmaceutical Manufacturing Handbook


Book Description

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.




The Politics of the Pharmaceutical Industry and Access to Medicines


Book Description

The book studies the pharmaceutical industry of India. It is one of the most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals. Please note: Taylor & Francis does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka