Validation of Biopharmaceutical Manufacturing Processes

✍ Scribed by Brian D. Kelley and R. Andrew Ramelmeier (Eds.)

Publisher: American Chemical Society
Year: 1998
Tongue: English
Leaves: 195
Series: ACS Symposium Series 698
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

Content: Historical, current, and future trends for validating biological processes / R. Andrew Ramelmeier, Brian D. Kelley, and Christi Van Horn --
Process characterization studies to facilitate validation of a recombinant protein fermentation / Jinyou Zhang, Jay Reddy, Peter Salmon, Barry Buckland, and Randy Greasham --
Validation of continuously perfused cell culture processes for production of monoclonal antibodies / S.C. Whitaker, R. Francis, and R.C. Siegel --
Establishment of proven acceptable process control ranges for production of a monoclonal antibody by cultures of recombinant CHO cells / Robert G. Gerber, Paul R. McAllister, Carol A. Smith, Thomas M. Smith, Dane W. Zabriskie, and Alan R. Gardner --
Validation of the recombinant coagulation Factor IX purification process for the removal of host cell DNA / M.W. Leonard, L. Sefton, R. Costigan, L. Shi, B. Hubbard, D. Bonam, B.D. Kelley, B. Foster, and T. Charlebois --
Worst-case approach to validation of operating ranges / Alan R. Gardner, Thomas M. Smith, Robert G. Gerber, and Dane W. Zabriskie --
Establishment of operating ranges in a purification process for a monoclonal antibody / Thomas M. Smith, Eileen Wilson, Robert G. Scott, John W. Misczak, John M. Bodek, and Dane W. Zabriskie --
Robustness testing of a chromatographic purification step used in recombinant Factor IX manufacture / Brian D. Kelley, Lei Shi, Duane Bonam, and Brian Hubbard --
Virus removal and inactivation : a decade of validation studies : critical evaluation of the data set / Joachim K. Walter, Franz Nothelfer, and William Werz --
Reuse validation of an anion exchange chromatography step for purification of clinical-grade ciliary neurotrophic factor / Somesh Nigam, Gary Ruezinsky, and James Dugger --
Start-up and validation of sterile formulation and filling processes for the manufacture of parenteral aluminum hydroxide-based vaccines / R.A. Ramelmeier, P.M. McHugh, M.S. Rienstra, C.J. Orella, W.L. Stobart, M.W. Henley, and R.D. Sitrin --
Changes in biologics regulations : impact on the development and validation of the manufacturing processes for well-characterized products / Kimberlee K. Wallace and Antonio R. Moreira.

📜 SIMILAR VOLUMES

Process Validation in Manufacturing of B

📁 Process Validation in Manufacturing of Biopharmaceuticals

✍ Anurag S. Rathore, Gail Sofer 📂 Library 📅 2012 🏛 CRC Press 🌐 English

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices</

Process validation in manufacturing of b

📁 Process validation in manufacturing of biopharmaceuticals : guidelines, current practices, and industrial case studies

✍ Anurag S Rathore; G K Sofer 📂 Library 📅 2005 🏛 Taylor & Francis 🌐 English

Content: Guidelines to Process Validation, G. Sofer Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes, R.J. Seely and J. Haury Process Characterization, J.E. Seely Scale-Down Models for Purification Processes: Approaches and Applications, R. Godavarti,

Process validation in manufacturing of b

📁 Process validation in manufacturing of biopharmaceuticals: guidelines, current practices, and industrial case studies

✍ Anurag S Rathore; G K Sofer 📂 Library 📅 2005 🏛 Taylor & Francis 🌐 English

Process Validation in Manufacturing of B

📁 Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

✍ Sofer, Gail 📂 Library 📅 2005 🏛 CRC Press 🌐 English

Written by experienced authorities in process validation, Process Validation in Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance

Process Validation in Manufacturing of B

📁 Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

✍ Sofer, Gail 📂 Library 📅 2000 🏛 CRC Press 🌐 English

Process Validation in Manufacturing Biop

📁 Process Validation in Manufacturing Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

✍ Rathore A. S. (ed.), Sofer G. (ed.) 📂 Library 📅 2005 🏛 Informa Healthcare 🌐 English

Rathore, a scientist in process development, and Sofer, director of regulatory compliance at a biosciences firm, offer practical guidelines, recommendations, and an abundance of industrial case studies demonstrating various techniques and approaches in the validation of biopharmaceutical processes.