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Reportlinker Adds Advances in Large Scale BioManufacturing and Scale-Up Production, 2nd ED
Date:8/19/2010

Process and Facility Design Approach

Disposable Technologies for Manufacturing of Biologics

Managing Large Volume, Single Use Disposables

Optimization of Antibody Processing: Upstream and Downstream

Simulated Moving Bed Chromatography

Implementation of Membrane Technology in Antibody Large-Scale Purification

Development of Viral Clearance Strategies for Large-Scale Monoclonal Antibody Production

Downstream Processing: Removing Economic and Technical Bottlenecks

Purification of Monoclonal and Genetically Engineered Antibodies

Regulatory Environment for Follow-on Biologics

Post-Approval Changes for Large Scale Biopharmaceutical Manufacturing: Global

FDA and Regulatory Issues in Biopharmaceutical Manufacturing

Strategic Issues: Capital Investments

Pricing Issues for Biotechnology Products

Economics of Scheduling, De-bottlenecking, and Cycle Time

Intellectual Property Considerations in Scale-Up of Biomanufacturing Processes

Forecasting Industry-wide Biopharmaceutical Manufacturing Capacity Requirements

Worldwide Therapeutic Protein Production Capacity

Authors and Reviewers:

Accelsiors Group International

Advanced Scientifics Inc.

Amgen, Inc.

Amgen, Inc.

Amgen, Inc.

Amgen, Inc.

Amgen, Inc.

Biogen IDEC

Biomanufacturing Training and Education Center

BioPharm Services UK

BioProcess Technology

Biotechnology Unit, NIDDK, NIH

Bristol Myers Squibb

Chromos, Burnaby, BC

Cambrex Bio Science

Clonex Development, Inc.

Consultants Inc.

Eli Lilly & Co.

Eli Lilly & Co.

Eli Lilly & Co.

Eli Lilly & Co.

Falconridge Associates

Fluor Corporation/Fluor Daniel Inc.

Fluor Corporation/Fluor Daniel Inc.

Fluor Corporation/Fluor Daniel Inc.


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