1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

From Lab Scale to Production Scale

Process Design, Operation and Validation

A 3-Day Intensive Continuing Education Course 1.8 CEUs)

Development of effective recovery and purification procedures for biopharmaceuticals requires integration from the start of regulatory expectations, molecular limitations of the product, application requirements, and economic constraints. All of these considerations must be addressed without compromise and usually within compressed timelines. Consistently fulfilling this challenge requires a thorough understanding of the mechanisms, strengths and weaknesses of the various recovery and purification tools; an appreciation for the physicochemical characteristics of the major contaminant classes; and a systematic approach to process development and scaleup.

THIS COURSE WILL IMPROVE YOUR KNOWLEDGE OF...

• recovery and purification methods of proteins.

• dominant characteristics of key contaminant classes like host cell protein, DNA, endotoxin, and viruses; and preemptive strategies for their removal.

• protein purification mechanisms, how to exploit them to the greatest possible benefit while avoiding their weaknesses.

• the difference between lab-scale and manufacturing scale purification

• how to sequence purification methods for maximum product purity and economical benefit.

• how to select materials and equipment that enhance cross-scale compatibility, how to avoid those that don’t.

• how to control bioburden throughout the process.

• how to select, improve on and validate process equipment.

• how to clean and sanitize process equipment.

• how to make process validation painless by integrating it into the evolving process design.

• how to provide the expected cleanliness environment of recovery and purification processes.